Jetrea

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
JETREA 0.375 mg/0.3 mL solution for injection 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each vial contains 0.375 mg of ocriplasmin* in 0.3 mL solution (1.25 mg/mL). This provides a usable 
amount to deliver a single dose of 0.1 mL containing 0.125 mg ocriplasmin. 
 
*Ocriplasmin is a truncated form of human plasmin produced by recombinant DNA technology in a 
Pichia pastoris expression system. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection (injection). 
Clear and colourless solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
JETREA is indicated in adults for the treatment of vitreomacular traction (VMT), including when 
associated with macular hole of diameter less than or equal to 400 microns (see section 5.1). 
 
4.2 Posology and method of administration 
 
JETREA must be administered by a qualified ophthalmologist experienced in intravitreal injections. 
The diagnosis of vitreomacular traction (VMT) should comprise of a complete clinical picture 
including patient history, clinical examination and investigation using currently accepted diagnostic 
tools, such as optical coherence tomography (OCT). 
 
Posology 
JETREA 0.375 mg/0.3 mL solution for injection is a ‘ready-diluted’ formulation, no further dilution is 
required. The recommended dose is 0.125 mg in 0.1 mL of the solution administered by intravitreal 
injection to the affected eye once as a single dose. Each vial should only be used once and for the 
treatment of a single eye. Treatment with JETREA in the other eye is not recommended concurrently 
or within 7 days of the initial injection in order to monitor the post-injection course including the 
potential for decreased vision in the injected eye. Repeated administration in the same eye is not 
recommended (see section 4.4).  
 
See section 4.4 for instructions on post-injection monitoring. 
 
Special populations 
Renal impairment 
No formal studies have been conducted with JETREA in patients with renal impairment. No dose 
adjustment or special considerations are anticipated for patients with renal impairment (see 
section 5.2). 
 
Hepatic impairment 
No formal studies have been conducted with JETREA in patients with hepatic impairment. No dose 
adjustment or special considerations are anticipated for patients with hepatic impairment (see 
section 5.2). 



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Elderly 
The elderly population has been studied in clinical studies. No dose adjustment is required.  
 
Paediatric population 
There is no relevant use of JETREA in children aged under 18 years for the indication of 
vitreomacular traction (VMT), including when associated with macular hole of diameter less than or 
equal to 400 microns. Currently available data on paediatric use are described in section 5.1. 
 
Method of administration 
Single use vial for intravitreal use only.  
 
Preoperative antibiotic drops may be administered at the discretion of the treating ophthalmologist. 
 
Precautions to be taken before handling or administering the medicinal product 
The intravitreal injection procedure should be carried out under controlled aseptic conditions, which 
include the use of surgical hand disinfection, sterile gloves, a sterile drape, a sterile eyelid speculum 
(or equivalent) and the availability of sterile paracentesis (if required). The periocular skin, eyelid and 
ocular surface should be disinfected and adequate anaesthesia and a broad spectrum topical 
microbiocide should be administered prior to the injection according to standard medical practice. 
 
Only 0.1 mL of the total 0.3 mL solution in the vial should be administered. Any excess volume 
should be expelled prior to injection in order to deliver a single dose of 0.1 mL containing 0.125 mg 
ocriplasmin. For handling of the medicinal product, see section 6.6.  
 
The injection needle should be inserted 3.5-4.0 mm posterior to the limbus aiming towards the centre 
of the vitreous cavity avoiding the horizontal meridian. The injection volume of 0.1 mL is then 
delivered into the mid-vitreous. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Active or suspected ocular or periocular infections.  
 
4.4 Special warnings and precautions for use 
 
Post-injection monitoring 
JETREA is administered by intravitreal injection only. Intravitreal injections have been associated 
with intraocular inflammation/infection, intraocular haemorrhage and increased intraocular pressure 
(IOP). Proper aseptic injection techniques must always be used. Following the intravitreal injection, 
patients should be monitored for any side effects such as (but not limited to) intraocular 
inflammation/infection and elevation in IOP. Transient increases in IOP including transient blindness 
and non-perfusion of the optic nerve have been seen within 60 minutes of injection of JETREA. 
Monitoring for increases in IOP may consist of a check for perfusion of the optic nerve head 
immediately after the injection and tonometry within 30 minutes following the injection. Intraocular 
inflammation/infection may be assessed using biomicroscopy between 2 and 7 days following the 
injection. Patients should be instructed to report symptoms suggestive of intraocular 
inflammation/infection or any other visual or ocular symptoms without delay. If any of the above 
events occur the patient should be treated according to standard medical practice. 
 
Bilateral treatment 
The safety and efficacy of JETREA administered to both eyes concurrently has not been studied. 
Therefore administration to both eyes concurrently is not recommended. 
 
Repeated administration 
Repeated administration of JETREA in the same eye has not been adequately studied and is therefore 
not recommended. 



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Population with no or limited data 
JETREA has not been studied in patients with large diameter macular holes (> 400 microns), high 
myopia (> 8 dioptre spherical correction or axial length > 28 mm), aphakia, history of rhegmatogenous 
retinal detachment, lens zonule instability, recent ocular surgery or intraocular injection (including 
laser therapy), proliferative diabetic retinopathy, ischaemic retinopathies, retinal vein occlusions, 
exudative age-related macular degeneration (AMD) and vitreous haemorrhage. Treatment is not 
recommended in such patients. 
 
There is limited experience in patients with non-proliferative diabetic retinopathy or history of uveitis 
(including active severe inflammation) or significant eye trauma. Caution should be exercised when 
treating such patients.  
 
Other 
The potential for lens subluxation or phacodonesis cannot be ruled out. If this event occurs, it should 
be treated according to standard medical practice. Patients should be monitored appropriately (see 
section 4.8 and 5.3). 
 
The effect of ocriplasmin (particularly in inducing resolution of vitreomacular adhesion or causing 
total posterior vitreous detachment [PVD]) is reduced in subjects with an epiretinal membrane (ERM) 
or a diameter of VMA > 1500 microns (see section 5.1).  
 
There is a risk for a significant decrease in visual acuity during the first week after the injection. 
Patients should be monitored appropriately (see section 4.8). 
 
Ophthalmological examinations may be abnormal following the administration of JETREA. These 
include optical coherence tomography (OCT), ophthalmoscopy (foveal reflex), colour vision test 
(Roth 28-hue) and full-field ERG. This should be taken into consideration when using these tests for 
the diagnosis or monitoring of other conditions (see section 4.8). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No formal interaction studies have been performed. 
 
Ocriplasmin is a proteolytic enzyme with serine protease activity which could be present in the eye for 
several days after intravitreal injection (see section 5.2). Administration in close temporal association 
with other medicinal products in the same eye may affect the activity of both medicinal products and 
is therefore not recommended. 
 
There are no clinical data on concomitant use of ocriplasmin with VEGF-inhibitors (vascular 
endothelial growth factor) and therefore it is not recommended.  
 
No systemic interactions are anticipated. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are no data for the use of JETREA in pregnant women. No reproductive toxicology studies have 
been performed. The systemic exposure of JETREA is expected to be very low after intravitreal 
injection. JETREA should be used during pregnancy only if the clinical benefit outweighs the 
potential risks. 
 
Breast-feeding 
It is unknown whether JETREA is excreted in human milk. JETREA should be used during 
breast-feeding only if the clinical benefit outweighs the potential risks. 
 



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Fertility 
There are no data on the effect of JETREA on fertility. 
 
4.7 Effects on ability to drive and use machines 
 
The intravitreal injection of JETREA may have a moderate influence on the ability to drive and use 
machines due to possible temporary visual disturbances (see section 4.8). In these cases, patients 
should not drive or use machines until the visual disturbances have resolved.  
 
4.8 Undesirable effects 
 
Summary of the safety profile 
Over 1400 patients have been treated with the recommended dose of 0.125 mg of JETREA in 
interventional clinical studies.  
 
All adverse reactions were ocular. In 3 clinical studies with follow-up from 6 months (TG-MV-006 
and TG-MV-007) to 24 months (TG-MV-014), the most commonly reported adverse reactions were 
vitreous floaters, eye pain, photopsia and chromatopsia as well as conjunctival haemorrhage resulting 
from the injection procedure. Most of the adverse reactions occurred within the first week after the 
injection. The majority of these reactions were non-serious, mild to moderate in intensity and resolved 
within 2 to 3 weeks. Information on resolution of specific events such as chromatopsia and ERG 
changes can be found in the relevant paragraph of the ‘description of selected adverse reactions’ 
section. 
 
The most clinically relevant adverse reactions included blindness transient, retinal tear, retinal 
detachment, lens subluxation and macular hole progression. 
 
Tabulated list of adverse reactions 
The following table summarises the adverse reactions reported in the treated eye in clinical studies 
and/or from post-marketing experience.  
 
Visual symptoms perceived in the contralateral eye or bilaterally have also been reported. 
 
The adverse reactions with a reasonable possibility of causal relationship to the injection procedure or 
JETREA are listed by MedDRA system organ class and frequency using the following convention: 
very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare 
(≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the 
available data). Within each frequency grouping, adverse reactions are presented in the order of 
decreasing seriousness. 
 



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Eye disorders Very common  
Vitreous floaters, eye pain, conjunctival haemorrhage, chromatopsia* 
 
Common  
Visual acuity reduced*, visual impairment1), visual field defect2), vision blurred, 
retinal haemorrhage, vitreous haemorrhage, macular hole*, macular degeneration, 
retinal degeneration, macular oedema3), retinal oedema4), retinal pigment 
epitheliopathy, metamorphopsia, conjunctival oedema, eyelid oedema, vitritis, 
anterior chamber cell, anterior chamber flare, iritis, photopsia, conjunctival 
hyperaemia, ocular hyperaemia, vitreous detachment, eye irritation, dry eye, 
foreign body sensation in eyes, eye pruritus, ocular discomfort, photophobia, 
lacrimation increased 
 
Uncommon  
Blindness transient, lens subluxation*, retinal tear*5), retinal detachment*5), night 
blindness, pupillary reflex impaired, diplopia, hyphaema, miosis, pupils unequal, 
corneal abrasion, anterior chamber inflammation, eye inflammation, conjunctival 
irritation 

Investigations Very common 
Retinogram abnormal*, colour vision test abnormal†  
 
Common 
Intraocular pressure increased, macular reflex abnormal, optical coherence 
tomography (OCT) abnormal* 

* see section ‘Description of selected adverse reactions’ 
1) including dim vision 
2) including scotoma  
3) including cystoid macular oedema 
4) including subretinal fluid 
5) events occurring pre-vitrectomy 
† using the Roth 28-hue colour vision test. See also section 4.4. 
 
Description of selected adverse reactions 
Visual acuity reduced 
In the placebo-controlled pivotal phase III studies (TG-MV-006 and TG-MV-007), 7.7% of JETREA 
patients and 1.6% of placebo patients had acute ≥ 2-line (≥ 10 ETDRS letters) loss in best-corrected 
visual acuity (BCVA) during the first week after injection with no alternative explanation for the 
change. The visual acuity decrease had resolved by the end of the studies for the majority of JETREA 
patients (80.6%) but there were some patients who had not recovered despite vitrectomy. The median 
time to resolution was 22 days. 
In study TG-MV-014, 2.8% of JETREA patients and 1.4% of sham patients had acute ≥ 2-line loss in 
BCVA during the first week after injection. Out of the 4 JETREA patients with acute visual acuity 
decrease, 3 recovered following vitrectomy. See section 4.4 for monitoring recommendations. 
 
Chromatopsia (including dyschromatopsia and colour vision test abnormal) 
Colour vision alterations (including yellowish vision and abnormal Roth 28-hue colour vision test) 
have been reported as a very common adverse reaction in patients injected with JETREA. The 
majority of events were non-serious, mild and generally resolved spontaneously. The median time to 
resolution was 3 months. 
 
Retinogram abnormal 
Electroretinographic (ERG) changes (a- and b-wave amplitude decrease) have been reported as a very 
common adverse reaction in patients injected with JETREA; in the majority of cases visual 
impairment and chromatopsia were also reported.  
In study TG-MV-014, a sub-set of 40 patients receiving JETREA systematically underwent ERG 
testing; the ERG changes which had developed in 16 out of 40 patients resolved in the majority of 
patients (13 out of 16). The median time to resolution was 6 months. ERG changes were not predictive 



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of negative outcomes in terms of visual acuity; visual acuity improved or was maintained in 15 out 
of 16 patients compared to baseline. 
 
Retinal breaks (tears and detachment) 
In the placebo-controlled pivotal phase III studies (TG-MV-006 and TG-MV-007), retinal breaks 
(tears and detachment) were reported in 1.9% of patients injected with JETREA vs. 4.3% injected with 
placebo. Most of these events occurred during or after vitrectomy in both groups. The incidence of 
retinal detachment that occurred pre-vitrectomy was 0.4% in the JETREA group and none in the 
placebo group, while the incidence of retinal tears (without detachment) that occurred pre-vitrectomy 
was 0.2% in the JETREA group and 0.5% in the placebo group.  
In study TG-MV-014, retinal tear was reported in 1.4% of patients injected with JETREA and 6.8% of 
sham recipients; the incidence of retinal detachment was 1.4% in both arms. In the sham group, no 
events occurred prior to vitrectomy. In the JETREA group, 1 patient (0.7%) developed retinal tear and 
retinal detachment between Day 0 and Day 7 post-injection. 
 
Macular hole 
In the placebo-controlled pivotal phase III studies (TG-MV-006 and TG-MV-007), events of macular 
hole (including both progression and new onset) were reported for 6.7% of all patients injected with 
JETREA vs. 9.6% injected with placebo at Month 6.  
In study TG-MV-014, events of macular hole (including both progression and new onset) were 
reported in 15.8% JETREA vs. 13.5% sham recipients at Month 24. 
Early progression rates of full-thickness macular hole (until Day 7 post-injection) at RPE (retinal 
pigment epithelium) level were higher in the JETREA treated patients compared to sham or placebo. 
Progression rates after Month 6, however, were higher in sham or placebo than in those treated with 
JETREA. Any persistence or progression of macular hole should be treated according to usual 
practice. 
 
Lens subluxation/phacodonesis 
One case of lens subluxation/phacodonesis was reported in clinical studies in adults and appears to 
have been possibly related to treatment with JETREA. In a paediatric study evaluating JETREA as an 
adjunct to vitrectomy, one case of subluxation was reported in a premature infant who received a 
single intravitreal injection of JETREA 0.175 mg. Lens subluxation was observed in 3 animal species 
at ocriplasmin concentrations above the intended clinical concentration (see section 5.3). 
 
Based on the proteolytic activity of ocriplasmin, preclinical and clinical findings, the potential for lens 
subluxation or phacodonesis cannot be ruled out. If this event occurs, it should be treated according to 
standard medical practice. 
 
Optical coherence tomography abnormal  
In study TG-MV-014, incomplete Inner Segment/Outer Segment (IS/OS) band, also referred to as 
Ellipsoid Zone, in the central area was very common at baseline (65.8% in the JETREA group and 
62.2% in the sham group). However, after treatment, a higher proportion of patients in the JETREA 
group had a change from an intact IS/OS band at baseline to an incomplete IS/OS band in the central 
area at a later time point compared with the sham group (7.7% and 2.8%, respectively at Day 28). 
Beyond the central area, abnormal aspects of the IS/OS band attributed to JETREA have been 
observed in up to 10% of patients.  
Ellipsoid Zone disruption within and outside the central area has been reported in non-interventional 
studies and post-marketing reports. In the majority of cases recovery occurred within 6 months. 
Subretinal fluid and signs and symptoms of impaired photoreceptor function including decreased 
visual acuity (in some cases severe) were reported in association with these events. 
 
See section 4.4 for monitoring recommendations. Routine observation is recommended in all above 
situations. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 



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professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
The clinical data on the effects of JETREA overdose are limited. One case of accidental overdose of 
0.250 mg ocriplasmin (twice the recommended dose) has been reported. The patient had a decrease in 
BCVA of 21 ETDRS letters from baseline that returned to within 9 letters of baseline at the end of the 
study. The patient also developed mild conjunctival hyperaemia, eye inflammation and miosis which 
resolved with corticosteroid eye drops. 
 
If an overdose occurs, close monitoring is recommended. If an adverse reaction occurs, it should be 
treated according to standard medical practice. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Ophthalmologicals, Other ophthalmologicals, ATC code: S01XA22  
 
Mechanism of action 
Ocriplasmin has a proteolytic activity against protein components of the vitreous body and the 
vitreoretinal interface (VRI) (e.g. laminin, fibronectin and collagen) and aims to dissolve the protein 
matrix responsible for the abnormal vitreomacular adhesion (VMA). The tight binding of the protein 
components within the macular area of the VRI contribute to vitreomacular traction (VMT), leading to 
visual impairment and/or macular holes. 
 
Clinical efficacy and safety 
The clinical efficacy and safety of JETREA for the treatment of vitreomacular traction (VMT) was 
assessed in 3 double-masked studies. 
 
Studies TG-MV-006 and TG MV-007 
The efficacy of JETREA was demonstrated in 2 pivotal multicentre, randomised, double-masked, 
placebo-controlled, 6-month studies in patients with VMT. A total of 652 patients (JETREA 464, 
placebo 188) were randomised in these 2 studies.  
 
In both pivotal studies, the proportion of patients who achieved VMA resolution at Day 28 (primary 
endpoint) was significantly (p≤0.003) higher in the JETREA group compared with the placebo group. 
The difference continued to be statistically significant through Month 6 in each study (p≤0.024). In the 
integrated data, 26.5% in the JETREA group compared with 10.1% in the placebo group achieved 
VMA resolution at Day 28 (p<0.001). The difference was maintained from Day 7 through Month 6 
(Figure 1). 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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Figure 1: Proportion of patients with VMA resolution up to Day 180 (Month 6) (TG-MV-006, 
TG-MV-007 and integrated data) 

 
Patients with no ERM at baseline were more likely to achieve VMA resolution at Day 28 compared 
with those who had ERM at baseline. In the integrated data, the VMA resolution rate at Day 28 was 
higher in patients treated with JETREA compared to placebo in both the subgroup without ERM 
(37.4% vs. 14.3%, p<0.001) and with ERM (8.7% vs. 1.5%, p=0.046). 
 
Patients with a smaller VMA diameter at baseline (≤ 1500 microns) were more likely to achieve VMA 
resolution at Day 28 compared with those who had a diameter > 1500 microns. In the integrated data, 
the VMA resolution rate at Day 28 was higher in patients treated with JETREA compared to placebo 
in both the subgroup with VMA ≤ 1500 microns at baseline (34.7% vs. 14.6%, p<0.001) and with 
VMA > 1500 microns at baseline (5.9% vs. 0%, p=0.113). 
 
In the integrated data, full-thickness macular hole (FTMH) was present at baseline in 106/464 (22.8%) 
patients and 47/188 (25%) patients in the JETREA and placebo groups, respectively. Of these, the 
proportion of patients who achieved FTMH closure without vitrectomy at Day 28 was higher in the 
JETREA group than the placebo group (40.6% vs. 10.6%, respectively; p<0.001). A difference was 
maintained through the end of the studies (Month 6).  
 
A significantly higher percentage of JETREA treated patients experienced total PVD at Day 28 
compared to placebo treated patients (integrated data: 13.4% vs. 3.7%, respectively; p<0.001).  
 
During the studies, vitrectomy could be performed at the discretion of the Investigator. JETREA 
treated patients were less likely to have had a vitrectomy by the end of the study (Month 6) compared 
with placebo treated patients (integrated data: 17.7% vs. 26.6%, respectively; p=0.016). 
 
A higher proportion of JETREA treated patients gained ≥ 2 or ≥ 3 lines in BCVA (irrespective of 
vitrectomy) at Month 6 (28.0% and 12.3%, respectively) compared with patients treated with placebo 
(17.1% and 6.4%) (p=0.003 and p=0.024, respectively). Also the proportion of patients gaining ≥ 2 or 
≥ 3 lines in BCVA without vitrectomy favoured JETREA at Month 6 (23.7% vs. 11.2%, p<0.001 for a 
gain ≥ 2 lines and 9.7% vs. 3.7%, p=0.008 for a gain ≥ 3 lines). 
 
In the integrated analysis of the National Eye Institute Visual Function Questionnaire-25 (VFQ-25), a 
numerical difference in favour of JETREA over placebo was shown in each sub-scale score, as well as 
the composite score. The difference for improvement in the general vision sub-scale score was 
statistically significant (6.1 JETREA vs. 2.1 placebo, p=0.024). 
 

0%

5%

10%

15%

20%

25%

30%

35%

%
 V

M
A 

R
es

ol
ut

io
n

Days Post-Injection

TG-MV-006
JETREA

TG-MV-007
JETREA

Combined
JETREA

TG-MV-006
Placebo

TG-MV-007
Placebo

Combined
Placebo

7 14 28 90 180

At all post-injection days, p≤0.024 in TG-MV-006, p≤0.009 in TG-MV-007, p<0.001 
in integrated data



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Study TG-MV-014 
The efficacy of JETREA has been further confirmed in a randomised, double-masked, sham-
controlled, 24-month study in patients with VMT finalised since the initial marketing authorisation 
approval. A total of 220 patients (JETREA 146, sham 74) were randomised in this study. 
 
The proportion of patients who achieved VMA resolution at Day 28 (primary endpoint) was 41.7% in 
the JETREA group compared with 6.2% in the sham group (p<0.001). This effect was maintained over 
time and VMA resolution was consistently greater in the JETREA group at each post-injection study 
visit compared with the sham group.  
 
In this study, FTMH was present at baseline in 50/145 (34.5%) and 26/73 (35.6%) patients in the 
JETREA and sham groups, respectively. Of these, 30% of JETREA treated patients and 15.4% of 
patients in the sham group experienced non-surgical FTMH closure at Month 24. All had done so by 
Month 3. 
 
The proportion of patients who underwent vitrectomy was smaller in the JETREA group than in the 
sham group at all visits. At Month 24, the proportions were 48/145 (33.3%) and 32/73 (43%), 
respectively. The most common reason for performing vitrectomy was FTMH (in 24.8% JETREA 
treated patients and 23.3 % sham patients). The proportion of patients who underwent vitrectomy for 
an event of VMA/VMT was 8.3% in the JETREA group compared to 19.2% in the sham group. 
 
The proportion of patients who gained ≥ 2 or ≥ 3 lines in BCVA at Month 6, irrespective of 
vitrectomy, was slightly higher in the JETREA group (36.2%, 18.6%) than in the sham group (28.6%, 
13.1%). At Month 24, the proportion of patients with ≥ 2 lines improvement from baseline in BCVA 
was greater in the JETREA group than in the sham group (50.5% vs. 39.1%). The proportion of 
patients with ≥3 lines improvement from baseline was only greater in the JETREA group (23.4% vs. 
12.8%, respectively) in the subgroup who had no FTMH at baseline. The ≥ 2 or ≥ 3 lines gain in 
BCVA without vitrectomy favoured JETREA over sham both at Month 6 (26.8%, 14.0%, vs. 15.62%, 
6.2%, respectively) and Month 24 (31.9%, 16.8%, vs. 11,7%, 4.1%, respectively).   
 
A greater proportion of patients in the JETREA group had a ≥ 5 points improvement in VFQ-25 
composite and sub-scale scores, irrespective of vitrectomy, at all visits. At Month 24, 51.4% of 
JETREA patients had a ≥ 5 points improvement in VFQ-25 composite score compared to 30.1% in the 
sham group. 
 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with 
JETREA in all subsets of the paediatric population in the treatment of vitreomacular traction (VMT), 
including when associated with macular hole of diameter less than or equal to 400 microns (see 
section 4.2 for information on paediatric use). 
 
The safety and efficacy of ocriplasmin in paediatric subjects scheduled for vitrectomy was 
investigated in study TG-MV-009. A single intravitreal injection of 0.175 mg (above the 
recommended dose), or placebo, was injected in the mid-vitreous of 24 eyes of children aged 0 to 
16 years, 30 to 60 minutes prior to the planned start of vitrectomy. The main reasons for vitrectomy 
were retinal detachment and retinopathy of prematurity. Treatment with ocriplasmin did not 
demonstrate an effect on posterior vitreous detachment rate, vitreous liquefaction grade, immediate 
postoperative retinal reattachment rate, development of proliferative vitreoretinopathy, or stage of 
retinopathy of prematurity. The safety findings observed in study TG-MV-009 were consistent with 
the known safety profile for JETREA. Based on the results of this study, the use of JETREA as an 
adjunct to vitrectomy in children, to facilitate vitreous separation and removal, is not recommended. 
 
Ethnicity 
Experience is limited in groups other than Caucasians. 
 



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5.2 Pharmacokinetic properties 
 
Ocriplasmin levels in the vitreous decrease rapidly after intravitreal administration. In a clinical study 
in patients scheduled for vitrectomy receiving 0.125 mg JETREA (corresponding to a theoretical start 
concentration of 29 µg/mL vitreous), mean ocriplasmin activity was 9% of theoretical start 
concentration 2-4 hours after injection and below the lower level of quantification at 7 days.  
 
Because of the small dose administered (0.125 mg), detectable levels of ocriplasmin in systemic 
circulation are not expected after intravitreal injection. 
 
When administered intravenously, ocriplasmin enters the endogenous protein catabolism pathway 
through which it is rapidly inactivated via its interactions with protease inhibitor α2-antiplasmin or 
α2-macroglobulin. The inactive ocriplasmin/α2-antiplasmin complex is cleared from the circulation 
with a half-life (t1/2) of several hours.  
 
Renal impairment 
No studies have been conducted to examine the pharmacokinetics of ocriplasmin in patients with renal 
impairment since the systemic exposure is expected to be very low after intravitreal administration. 
 
Hepatic impairment 
No studies have been conducted to examine the pharmacokinetics of ocriplasmin in patients with 
hepatic impairment since the systemic exposure is expected to be very low after intravitreal 
administration. 
 
5.3 Preclinical safety data 
 
The intravitreal toxicity of ocriplasmin has been evaluated in rabbits, monkeys and minipigs. 
Ocriplasmin induced an inflammatory response and transient ERG changes in rabbits and monkeys, 
while no inflammation or ERG changes were observed in minipigs. In rabbits and monkeys, the 
incidence of vitreous cell infiltrates tended to resolve over time. In monkeys, after administration of 
125 µg/eye (68 µg/mL vitreous) the ERG was fully recovered by Day 55. Lens subluxation was 
observed in the 3 species at ocriplasmin concentrations at or above 41 µg/mL vitreous, a concentration 
above the intended clinical concentration of 29 µg/mL. This effect appeared to be dose-related and 
was observed in all animals administered intravitreal ocriplasmin more than once. Pathological 
changes related to intraocular haemorrhage were observed in rabbits and monkeys. It remains unclear 
if this haemorrhage is related to the injection procedure itself or administration of ocriplasmin. No 
systemic toxicity was observed after intravitreal administration of ocriplasmin. 
 
The systemic toxicity of ocriplasmin has been evaluated in both rat and dog. Intravenous 
administration of 10 mg/kg was generally well tolerated in both rat and dog whether administered as 
single dose or as repeated dose. 
 
No carcinogenicity, mutagenicity or reproductive and developmental toxicity data are available.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium chloride (NaCl) 
Mannitol  
Citric acid  
Sodium hydroxide (NaOH) (for pH adjustment) 
Hydrochloric acid (HCl) (for pH adjustment) 
Water for injections  
 



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6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
3 years when stored in a freezer (-20 °C ± 5 °C). 
 
After thawing 
The unopened vial in the original carton protected from light may be stored in a refrigerator 
(2 °C to 8 °C) for up to 1 week. The new in-use expiry date should be calculated and noted on the 
carton before it is placed in the refrigerator.  
 
Once removed from the freezer or refrigerator, the medicinal product may be kept below 25 °C for up 
to 8 hours. At the end of this period the product must be used or discarded.  
 
Do not refreeze a vial once it has been thawed. 
 
After opening 
From a microbiological point of view, the medicinal product must be used immediately after opening. 
The vial and any unused portion of the solution must be discarded after single use. 
 
6.4 Special precautions for storage 
 
Store in a freezer (-20 °C ± 5 °C).  
For storage conditions after thawing/opening of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
0.3 mL solution in a vial (type I glass) closed with a chlorobutyl rubber stopper and a blue 
polypropylene flip-off cap. Pack containing 1 vial.  
 
6.6 Special precautions for disposal and other handling 
 
Vials are for single use only. 
 
JETREA 0.375 mg/0.3 mL solution for injection is a ‘ready-diluted’ formulation, no further dilution is 
required. Only 0.1 mL of the total 0.3 mL solution in the vial should be administered. Any excess 
volume should be expelled prior to injection in order to deliver a single dose of 0.1 mL containing 
0.125 mg ocriplasmin. 
 
Instructions for use 
 
1. Remove the vial from the freezer and allow to thaw at room temperature (takes about 

2 minutes). 
 
2. Once completely thawed, remove the protective blue 

polypropylene flip-off cap from the vial. 
 

 
 JETREA 0.375 mg/0.3 mL solution for injection 



13 
 

3. Disinfect the top of the vial with an alcohol wipe. 
 

 
 JETREA 0.375 mg/0.3 mL solution for injection 

 
4. Visually inspect the vial for particulate matter. Only a clear, colourless solution without visible 

particles should be used. 
 

5. Using aseptic technique, withdraw all of the solution 
using an appropriate sterile needle (slightly incline the 
vial to ease withdrawal) and discard the needle after 
withdrawal of the vial contents. Do not use this needle for 
the intravitreal injection. 

 

 
 JETREA 0.375 mg/0.3 mL solution for injection 

  
6. Replace the needle with an appropriate sterile needle, 

carefully expel the excess volume from the syringe by 
slowly depressing the plunger so that the plunger tip 
aligns with the 0.1 mL line on the syringe (corresponding 
to 0.125 mg ocriplasmin). 
 

 
 JETREA 0.375 mg/0.3 mL solution for injection 

  
7. Inject 0.1 mL of the solution immediately into the mid-vitreous.  
 
8. Discard the vial and any unused portion of the solution after single use. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
7. MARKETING AUTHORISATION HOLDER 
 
Inceptua AB 
Gustavslundsv. 143 
16751 Bromma 
Sweden 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/819/002 



14 
 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 13 March 2013 
Date of latest renewal: 8 December 2017 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 

http://www.ema.europa.eu/


15 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 

SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE 
FOR BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 



16 
 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND 
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer(s) of the biological active substance(s) 
 
FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED 
Belasis Avenue 
Billingham, Cleveland  
TS23 1LH  
United Kingdom 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Oxurion NV 
Gaston Geenslaan 1 
B-3001 Leuven 
BELGIUM 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic Safety Update Reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency;  
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

• Additional risk minimisation measures  
 
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree an 
educational programme with the National Competent Authority. 
 
The MAH shall ensure that, following discussions and agreement with the National Competent 
Authorities in each Member State where JETREA will be marketed, at launch and after launch, all 
healthcare professionals who are expected to use JETREA are provided with the following items: 



17 
 

 
• Summary of Product Characteristics (SmPC) 
• Information packs for the patients 
 
The patient information pack should be provided in printed and in audio format, and contain the 
following key elements: 
 
• Patient information leaflet 
• How to prepare for Jetrea treatment 
• How is Jetrea treatment administered 
• What are the steps following treatment with Jetrea 
• Key signs and symptoms of serious adverse events 
• When to seek urgent attention from the health care provider 



18 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



19 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



20 
 

 PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
JETREA 0.375 mg/0.3 mL solution for injection 
ocriplasmin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 vial contains 0.375 mg ocriplasmin in 0.3 mL solution (1.25 mg/mL). This provides a usable amount 
to deliver a single dose of 0.1 mL containing 0.125 mg ocriplasmin. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium chloride, mannitol, citric acid, sodium hydroxide, hydrochloric acid, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
1 vial  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Ready-diluted 
For single use only 
Read the package leaflet before use. 
Intravitreal use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a freezer. After thawing, unopened vial may be stored for up to 1 week in a refrigerator. Use 
thawed solution by: ----- / ----- / ----- 
 



21 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Inceptua AB 
Gustavslundsv. 143 
16751 Bromma 
Sweden 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/819/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted.  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



22 
 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
JETREA 0.375 mg/0.3 mL injection 
ocriplasmin 
Intravitreal use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
 
6. OTHER 
 



23 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



24 
 

 Package leaflet: Information for the patient 
 

JETREA 0.375 mg/0.3 mL solution for injection 
Ocriplasmin 

 
Read all of this leaflet carefully before you are given this medicine because it contains important 
information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor. 
- If you get any side effects, talk to your doctor. This includes any possible side effects not listed 

in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Jetrea is and what it is used for  
2. What you need to know before you are given Jetrea 
3. How Jetrea is given 
4. Possible side effects 
5. How Jetrea is stored 
6. Contents of the pack and other information 
 
 
1. What Jetrea is and what it is used for 
 
Jetrea contains the active substance ocriplasmin.  
 
Jetrea is used to treat adults with an eye disease called vitreomacular traction (VMT), including when 
it is associated with a small hole in the macula (central part of the light-sensitive layer at the back of 
the eye). 
 
VMT is caused by traction resulting from a persistent attachment of the vitreous humour (jelly-like 
material in the back of the eye) to the macula. The macula provides central vision that is needed for 
everyday tasks such as driving, reading and recognising faces. VMT can cause symptoms such as 
distorted or decreased vision. When the disease progresses the traction may eventually result in the 
formation of a hole in the macula (called a macular hole). 
 
Jetrea works by separating the vitreous humour from the macula, and helping to close the macular hole 
if one is present, which may decrease the symptoms caused by VMT. 
 
 
2. What you need to know before you are given Jetrea 
 
You must not be given Jetrea 
- if you are allergic to ocriplasmin or any of the other ingredients of this medicine (listed in 

section 6);  
- if you have (or suspect you may have) an infection in or around your eye. 

 
Warnings and precautions 
Talk to your doctor/ophthalmologist before you are given Jetrea. 
 
Jetrea is given as an injection into the eye. Your doctor/ophthalmologist will monitor you in case you 
develop an infection or any complications after the injection. You should contact your 
doctor/ophthalmologist immediately if you develop any of the eye symptoms described in section 4, 
after an injection of Jetrea. 
 
You will not be given Jetrea into both eyes at the same time.  
 
You will not be given Jetrea more than once into the same eye. 



25 
 

 
Tell your doctor/ophthalmologist if you have or have had any eye conditions or eye treatments. Your 
doctor/ophthalmologist will decide if treatment with Jetrea is right for you. 
 
Children and adolescents 
There is no relevant use of Jetrea in children and adolescents below 18 years old. The use of Jetrea is 
therefore not recommended in this patient group.  
 
Other medicines and Jetrea 
Tell your doctor/ophthalmologist if you are taking, have recently taken or might take any other 
medicines. Inform your doctor/ophthalmologist if you have had an injection of a medicine into the eye 
recently. This information will be taken into account to evaluate if and when Jetrea can be injected 
into the same eye.  
 
Pregnancy and breast-feeding  
There is no experience of using Jetrea in pregnant women or during breast-feeding. Jetrea should not 
be used during pregnancy or breast-feeding unless your doctor/ophthalmologist thinks it is clearly 
necessary. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a 
baby, ask your doctor/ophthalmologist for advice before being given this medicine. 
 
Driving and using machines 
After Jetrea treatment you may experience some decrease in vision for a limited amount of time. If this 
happens, do not drive or use any tools or machines until your vision improves. 
 
 
3. How Jetrea is given 
 
Jetrea must be given by a qualified ophthalmologist (eye specialist) who has experience in giving 
injections into the eye. 
 
Jetrea is given as a single injection into the affected eye. The recommended dose is 0.125 mg.  
 
Your doctor/ophthalmologist may ask you to use antibiotic eye drops before and after the injection in 
order to prevent any possible eye infection. 
 
On the day of the injection, your doctor/ophthalmologist will use antimicrobial eye drops and clean 
your eye and eyelid carefully to prevent infection. Your doctor/ophthalmologist will also give you a 
local anaesthetic to prevent any pain from the injection.  
 
After the injection, your doctor/ophthalmologist will monitor your vision.  
 
If you have any further questions on the use of this medicine, ask your doctor/ophthalmologist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Contact your doctor/ophthalmologist immediately if you develop any of the following symptoms 
after injection of Jetrea. Your doctor/ophthalmologist will monitor you and take corrective measures if 
needed. 
- A severe decrease in vision has been reported in up to 1 in 10 patients within one week after Jetrea 

treatment. This is generally reversible and will usually disappear without treatment.  
- Symptoms such as eye pain, worsening eye redness, severely blurred or decreased vision, 

increased sensitivity to light or increased number of dark floating spots in the field of vision 
(floaters) are also seen in up to 1 in 10 patients and may be the signs of an infection, bleeding, 
separation or tear of the retina or an increase in the pressure inside the treated eye.  



26 
 

- Symptoms such as fluctuation of vision, double vision, headache, halos around light, nausea and 
vomiting have been reported in up to 1 in 100 patients and may be the signs of a displacement or 
wobbling of the lens in the eye from its normal position.  

 
Talk to your doctor/ophthalmologist if you develop any of the additional side effects listed below: 
 
Very common side effects (may affect more than 1 in 10 patients): 
- dark floating spots in the field of vision (floaters) 
- eye pain 
- bleeding on the surface of the eye  
- colour vision changes 
 
Common side effects (may affect up to 1 in 10 patients): 
- decreased vision which may be severe 
- visual disturbances  
- decreased vision or blind spots in parts of the field of view  
- blurred vision  
- bleeding inside the eye 
- blind spot or blind area in the centre of the vision 
- distorted vision  
- swelling of the surface of the eye 
- swelling of the eyelid 
- inflammation of the eye  
- flashes of light in the eye  
- eye redness  
- irritation on the surface of the eye   
- dry eye  
- a feeling of having something in the eye  
- itching of the eye   
- eye discomfort  
- sensitivity to light  
- increased tear production  
 
Uncommon side effects (may affect up to 1 in 100 patients): 
- transient severe decreased vision  
- difficulty in seeing well at night or in dim light 
- disturbance in your eye’s reaction to the light that may increase your sensitivity to light (pupillary 

reflex impaired) 
- double vision  
- accumulation of blood in the front part of the eye 
- abnormal constriction of the pupil (black part in the centre of the eye)  
- different sized pupils  
- a scratch or scrape of the cornea (transparent layer that covers the front of the eye)  
 
Some tests and imaging of the back of the eye (retina) have been found to be abnormal after Jetrea 
administration. Your doctor will be aware of this and will take it into account when monitoring your 
eye. 
 
Some effects (such as flashes, floaters) can also be perceived from the untreated eye in some cases.  
 
Reporting of side effects 
If you get any side effects, talk to your doctor/ophthalmologist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


27 
 

5. How Jetrea is stored 
 
Keep this medicine out of the sight and reach of children. 
 
Information about storage and the time to use Jetrea once it has been thawed are described in the 
section intended for healthcare professionals only. 
 
Your ophthalmologist/doctor or pharmacist is responsible for storing this medicine and disposing of 
any unused solution correctly. 
 
 
6. Contents of the pack and other information 
 
What Jetrea contains  
- The active substance is ocriplasmin. One vial of Jetrea contains 0.375 mg of ocriplasmin in 

0.3 mL solution.  
- The other ingredients are sodium chloride (NaCl), mannitol, citric acid, sodium hydroxide 

(NaOH) (for pH adjustment), hydrochloric acid (HCl) (for pH adjustment) and water for 
injections. 

 
What Jetrea looks like and contents of the pack 
Jetrea is a solution for injection in a vial. The solution is clear and colourless.  
Each pack contains one vial. 
 
Marketing Authorisation Holder 
Inceptua AB 
Gustavslundsv. 143 
16751 Bromma 
Sweden 
 
Manufacturer 
Oxurion NV 
Gaston Geenslaan 1 
B-3001 Leuven 
Belgium 
 
This leaflet was last revised in 
 
Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu  
 
--------------------------------------------------------------------------------------------------------------------------- 
 
The following information is intended for healthcare professionals only: 
 
Jetrea must be administered by a qualified ophthalmologist experienced in intravitreal injections. The 
diagnosis of vitreomacular traction (VMT) should comprise of a complete clinical picture including 
patient history, clinical examination and investigation using currently accepted diagnostic tools, such 
as optical coherence tomography (OCT). 
 
JETREA 0.375 mg/0.3 mL solution for injection is a ‘ready-diluted’ formulation, no further dilution is 
required. The recommended dose is 0.125 mg in 0.1 mL of the solution administered by intravitreal 
injection to the affected eye once as a single dose. Each vial should only be used once and for the 
treatment of a single eye. Treatment with Jetrea in the other eye is not recommended concurrently or 
within 7 days of the initial injection in order to monitor the post-injection course including the 

http://www.ema.europa.eu/


28 
 

potential for decreased vision in the injected eye. Repeated administration in the same eye is not 
recommended. 
 
See section 4.4 of the Summary of Product Characteristics for instructions on post-injection 
monitoring. 
 
Single use vial for intravitreal use only. 
 
Preoperative antibiotic drops may be administered at the discretion of the treating ophthalmologist.  
 
The intravitreal injection procedure should be carried out under controlled aseptic conditions, which 
include the use of surgical hand disinfection, sterile gloves, a sterile drape, a sterile eyelid speculum 
(or equivalent) and the availability of sterile paracentesis (if required). The periocular skin, eyelid and 
ocular surface should be disinfected and adequate anaesthesia and a broad spectrum topical 
microbiocide should be administered prior to the injection according to standard medical practice. 
 
Only 0.1 mL of the total 0.3 mL solution in the vial should be administered. Any excess volume 
should be expelled prior to injection in order to deliver a single dose of 0.1 mL containing 0.125 mg 
ocriplasmin.  
 
The injection needle should be inserted 3.5-4.0 mm posterior to the limbus aiming towards the centre 
of the vitreous cavity avoiding the horizontal meridian. The injection volume of 0.1 mL is then 
delivered into the mid-vitreous. 
 
Instructions for use 
 
1. Remove the vial from the freezer and allow to thaw at room temperature (takes about 2 minutes). 
2. Once completely thawed, remove the protective blue polypropylene flip-off cap from the vial 

(Figure 1). 
3. Disinfect the top of the vial with an alcohol wipe (Figure 2). 
4. Visually inspect the vial for particulate matter. Only a clear, colourless solution without visible 

particles should be used. 
5. Using aseptic technique, withdraw all of the solution using an appropriate sterile needle (slightly 

incline the vial to ease withdrawal) (Figure 3) and discard the needle after withdrawal of the vial 
contents. Do not use this needle for the intravitreal injection. 

6. Replace the needle with an appropriate sterile needle, carefully expel the excess volume from the 
syringe by slowly depressing the plunger so that the plunger tip aligns with the 0.1 mL line on the 
syringe (corresponding to 0.125 mg ocriplasmin) (Figure 4). 

7. Inject 0.1 mL of the solution immediately into the mid-vitreous.  
8. Discard the vial and any unused portion of the solution after single use.  
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 



29 
 

JETREA  
0.375 mg/0.3 mL 

solution for injection 
 

JETREA  
0.375 mg/0.3 mL 

solution for injection 
 

JETREA 
0.375 mg/0.3 mL 

solution for injection 
 

JETREA 
0.375 mg/0.3 mL 

solution for injection 
 

  
  

Figure 1 Figure 2 Figure 3 Figure 4 
 
Information about storage 
 
Do not use this medicine after the expiry date which is stated on the label and on the carton after EXP. 
The expiry date refers to the last day of that month. 
 
Store in a freezer (-20 °C ± 5 °C). 
 
After thawing 
The unopened vial in the original carton protected from light may be stored in a refrigerator 
(2 °C to 8 °C) for up to 1 week. The new in-use expiry date should be calculated and noted on the 
carton before it is placed in the refrigerator.  
 
Once removed from the freezer or refrigerator, the medicinal product may be kept below 25 °C for up 
to 8 hours. At the end of this period the product must be used or discarded.  
 
Do not refreeze a vial once it has been thawed. 
 
After opening 
From a microbiological point of view, the medicinal product must be used immediately after opening. 
The vial and any unused portion of the solution must be discarded after single use. 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) ANDMANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET