A Real-world Study to Evaluate the Efficacy and Safety of 9% Dexamethasone Intraocular Injection for the Treatment of Inflammation Associated With Cataract Surgery
Phase: PHASE4
Conditions: Inflammation, Cataract
Sponsor: Ocumension Therapeutics (Shanghai) Co., Ltd

Study Title: 
A Real-world Study on the Efficacy and Safety of 9% 
Dexamethasone Insert in the Treatment of Postoperative 
Inflammation Following Cataract Surgery 
 
Study Drug:  
9% Dexamethasone Insert 
 
Sponsor: 
 
 
 
 
Study Indication:  
 
Ocumension Therapeutics (Shanghai) Co., Ltd 
56F, One Museum Place, 669 Xin Zha Road, Jing’an District, 
Shanghai, PRC 200041 
 
 
Postoperative inflammation following cataract surgery 
Protocol No.:  
 
OT-502-002 
NCT06497699 
June 30, 2022 
 
 
 
 

Study Summary 
Title  
A Real-world Study on the Efficacy and Safety of 9% 
Dexamethasone Insert in the Treatment of Postoperative 
Inflammation Following Cataract Surgery 
Protocol Number 
OT-502-002 
Study Phase 
Real-word Study 
Study Duration 
90 days 
Study Center(s) 
2 sites  
Objectives 
To evaluate the efficacy and safety of Dexamethasone Insert 
in the treatment of postoperative inflammation 
following cataract surgery in real-world clinical settings; and 
to evaluate the ease of use, time taken, and 
safety of the Dexamethasone Insert injector 
Numbers of subjects
Plan: 263 subjects (113 subjects in the 9% Dexamethasone 
Insert group, 150 subjects in the external control 
group). 
Actual enrollment: 113 subjects in the 9% Dexamethasone 
Insert group, 150 subjects in the external control 
group; after propensity score (PS) 1:1 matching, 208 subjects 
(104 subjects in the 9% Dexamethasone Insert 
group, 104 subjects in the external control group) were 
included in the post-matching analysis. 
Eligibility Criteria 
Inclusion Criteria: 
1) Patients must be able to understand and sign the informed 
consent form (ICF), and be able to comply 
with all study procedures. 
2) Male or female patients over 40 years old who planned to 
undergo phacoemulsification combined with 
intraocular lens implantation surgery. 
Exclusion Criteria: 
1) Known allergy to dexamethasone or any component of the 
Dexamethasone Insert. 
2) History of endophthalmitis of any cause in either eye, 
presence of corneal abnormalities or 
malnutrition. 
3) Patients with ocular hypertension, with an intraocular 
pressure (IOP) >21 mmHg in the study eye at 
screening, regardless of anti-glaucoma monotherapy. 
4) Posterior capsule rupture or lens dislocation, anterior 
hyaloid membrane rupture, vitreous loss, and 
floppy iris syndrome during cataract surgery. 
5) Other circumstances that, in the opinion of the 
investigator, the subject was not suitable for 
participation in the study 

 
1.Introduction 
Since the development of synthetic corticosteroids in the 1950s, corticosteroids have 
been used to treat eye disorders. They are important compounds for the treatment of 
inflammatory diseases. After entering cells, these compounds bind to glucocorticoid 
receptors, and are transported to the nucleus, activating the expression of anti-
inflammatory genes, and inhibiting the expression of pro-inflammatory genes. 
 
Dexamethasone was developed in the 1960s for the treatment of eye disorders and has 
since been used in ophthalmology. In current clinical practice, dexamethasone is used 
as a topical eye drop (in the form of a 1% ophthalmic suspension) to treat eye 
inflammation. Corticosteroid eye drops are commonly used to treat inflammation 
associated with cataract operations. Eye drops may need to be administered multiple 
times a day, presenting potential compliance issues; if compliance is poor, the 
expected therapeutic effect may not be achieved. As an alternative medication, 
dexamethasone delivered via short-term delivery systems can ensure subject 
compliance. 
 
The Dexamethasone Insert, a new corticosteroid intraocular implant developed by 
EyePoint Pharmaceuticals in the United States (brand name DEXYCU®), was 
approved by the United States Food and Drug Administration (FDA) in February 
2018 (approval number: NDA 208912) for the treatment of postoperative ocular 
inflammation. Under the support of the "National Nine Policies", drugs that have been 
approved for marketing in developed countries in Europe and America, not yet 
approved in China, and are urgently needed clinically, can be "piloted" in the Hainan 
Boao Lecheng International Medical Tourism Pilot Zone. In line with national spirit 
and the current urgent clinical needs domestically, the Hainan Provincial Health 
Commission and the Hainan Provincial Medical Products Administration have 
approved the use of the Dexamethasone Insert in the Hainan Boao Lecheng 
International Medical Tourism Pilot Zone. 
 
The Ophthalmic Center of Boao Super Hospital relies on the advanced talents, 
technology, resources, and expert support of the Eye Hospital Affiliated to Wenzhou 
Medical University, covering all optometry disciplines, and shares resources with the 
Eye Hospital Affiliated to Wenzhou Medical University in clinical diagnosis, 
telemedicine, and joint discipline construction. Therefore, a real-world study on the 
efficacy and safety of the Dexamethasone Insert was conducted at the Ophthalmic 
Center of Boao Super Hospital, with research processes (including subject screening, 
Dexamethasone Insert operation, subject data generation, and postoperative follow-
up) consistent with real-world clinical diagnosis and treatment standards, and the 
study results could be representative of real-world data. 
 
2.Overall Study Design and Plan 

This was a prospective, real-world study. It was planned to prospectively collect the 
medical histories and follow-up data of 113 subjects who received Dexamethasone 
Insert in real-world settings in China, to evaluate the efficacy and safety of 
Dexamethasone Insert, and conduct a survey among 30 injector users on the ease of use, 
time taken, and safety of using the Dexamethasone Insert injector. Prospectively 
enrolled subjects returned to the study sites in Hainan for follow-up on Days 1, 8, 30, 
and 90 after Dexamethasone Insert injection. In addition to prospectively collecting 
data from subjects receiving Dexamethasone Insert as mentioned above, data from 150 
cataract subjects previously treated using conventional clinical methods at selected 
medical institutions were also prospectively collected as an external control 
(conventional treatment) to further evaluate the efficacy and safety of the 
Dexamethasone Insert. Prospective collection of data of the external control subjects 
was conducted as consistently as possible with that of the Dexamethasone Insert group. 
 
3. Selection of Study Population 
3.1 Inclusion Criteria 
Only subjects who met all of the following conditions were included in this study: 
1) Patients must be able to understand and sign the informed consent form (ICF), and 
be able to comply with all study procedures. 
2) Male or female patients over 40 years old who planned to undergo 
phacoemulsification combined with intraocular lens implantation surgery. 
3.2 Exclusion Criteria 
Subjects were not allowed to participate in this study if they met any of the following 
criteria: 
1) Known allergy to dexamethasone or any component of the Dexamethasone Insert. 
2) History of endophthalmitis of any cause in either eye, presence of corneal 
abnormalities or malnutrition. 
3) Patients with ocular hypertension, with an IOP >21 mmHg in the study eye at 
screening, regardless of anti-glaucoma monotherapy. 
4) Posterior capsule rupture or lens dislocation, anterior hyaloid membrane rupture, 
vitreous loss, and floppy iris syndrome during cataract surgery. 
5) Other circumstances that, in the opinion of the investigator, the subject was not 
suitable for participation in the study. 
 
4. Statistical Plan 
Descriptive statistics will be performed for de-identified demographic data, surgical 
details, clinical outcomes, and surgeon satisfaction.