Title: Fluocinolone acetonide ocular implant for treating recurrent non-infectious uveitis [ID1039]
Funder: Department of Health and Social Care

Abstract: To appraise the clinical and cost effectiveness of fluocinolone acetonide ocular implant within its marketing authorisation for treating recurrent non-infectious uveitis.

Lay abstract: Uveitis is inflammation of the uveal tract of the eye, which consists of the iris, the ciliary body and the choroid. Uveitis can be caused by a bacterial, viral or fungal infection or trauma to the eye, but it is more commonly associated with an underlying autoimmune disorder. The autoimmune disorder may be associated with systemic disease, such as ankylosing spondylitis, or it may affect only the eyes. One or both eyes may be affected. Symptoms of uveitis include eye pain and redness of the eye, problems with vision, sensitivity to light, temporary loss of peripheral vision and headaches. Uveitis may be acute (where the symptoms come in short episodes of about 6 weeks and may recur) or chronic (where the inflammation persists for more than 3 months possibly flaring up at times). Consequences of uveitis can include glaucoma (increased pressure inside the eye), cataracts (cloudiness of the lens), cystoid macular oedema (swelling of the retina) and permanent loss of peripheral or central vision. Uveitis is classified according to the location of the inflammation. Anterior uveitis is inflammation of the iris. Intermediate uveitis affects the posterior part of the ciliary body and the vitreous humour. Posterior uveitis affects the choroid at the back of the eye, and often involves the retina. Posterior segment uveitis includes both intermediate and posterior uveitis. Pan uveitis is inflammation of the whole of the uveal tract (front and back). Intermediate, posterior and pan uveitis are less common than anterior uveitis (they account for around 1 in 4 uveitis diagnoses (1)). It is estimated that non-infectious uveitis affects less than 4.8 people per 10,000 in the European Union (2). It is estimated that up to 26,300 people are affected by non-infectious uveitis in England each year. Uveitis affects people of any age, but most commonly affects people between the ages of 20 and 59 years (3). There is no nationally agreed treatment pathway for recurrent non-infectious uveitis. Non-infectious uveitis (whether or not it is associated with an underlying systemic autoimmune disorder) is initially treated with corticosteroids. Corticosteroids may be administered systemically (orally or parenterally), by periocular or intravitreal injection, or using intravitreal implants. Additionally, if the front of the eye is also affected, topical corticosteroids and dilating eye drops may be offered. Systemic immunosuppressive drugs such as methotrexate, ciclosporin, mycophenolate mofetil and azathioprine may be offered. This may allow a reduction in the corticosteroid dose and associated complications (known as the steroid-sparing effect). Immunosuppressive drugs may also be given when corticosteroids are c contraindicated or not tolerated. If there is an inadequate response to immunosuppressive treatments, or if they are not tolerated, biological tumour necrosis factor (TNF)-alpha inhibitors may be used. In rare cases, surgery (vitrectomy) may be needed to treat complications associated with recurrent or severe uveitis. References 1. NHS Choices website. Uveitis – overview. Accessed July 2018. 2. European Medicines Agency (2010) Public summary of opinion on orphan designation: Fluocinolone acetonide for the treatment of non- infectious uveitis. 3. RNIB. Uveitis. Accessed July 2018.

Research activity codes: 6.1 PHARMACEUTICALS;6.3 MEDICAL DEVICES
Health categories: EYE