NICE Recommends OZURDEX(R), an Innovative Treatment for Retinal Vein Occulsion (RVO), a Common Cause of Vision Loss

MARLOW, England, June 6, 2011 /PRNewswire/ --

Allergan announces today that the National Institute for Health and Clinical Excellence (NICE) has recommended OZURDEX(R) (dexamethasone 0.7mg intravitreal implant in applicator) for the treatment of macular oedema due to central retinal vein occlusion (CRVO) and also for branch retinal vein occlusion (BRVO) where laser photocoagulation is neither beneficial nor appropriate.

RVO is an eye condition that can lead to severe damage to the retina, visual impairment and even blindness. The visual impairment that often results from RVO can significantly impact on patients' quality of life and ability to do everyday things, such as reading a newspaper, watching a film or driving.[1] Up to 25,000 patients in the UK every year suffer from macular oedema associated with RVO and may be suitable for treatment with OZURDEX.[2]

OZURDEX is an innovative, first-of-its-kind biodegradable intravitreal implant containing dexamethasone, a highly potent corticosteroid, administered via a specially designed, single use applicator.[3,4] Dexamethasone is slowly released from the implant into the eye and acts locally to control oedema, reduce inflammation around the occlusion and improve vision. A single injection can offer long lasting improvement with benefits demonstrated to last for up to six months.

Mr. Ian Pearce, Consultant Ophthalmologist and the Clinical Expert representative of the Royal College of Ophthalmologists said: "The availability of a licensed, effective and now NICE recommended treatment is a significant step forward for management of RVO patients in England and Wales and we look forward to ophthalmologists providing the treatment ASAP."

"RVO is the second most common cause of reduced vision due to retinal vascular disease. The decision announced today represents the first NICE recommendation for a licensed treatment for macular oedema associated with RVO and with it NICE has made available to retinal specialists and their patients an important treatment for this potentially devastating condition," said Mr. Douglas D. Ingram, Executive Vice President, President, Allergan, Europe, Africa and the Middle East. "We look forward to working with retinal specialists, hospitals and commissioning groups in the UK to support the National Health Service in rapidly adopting this cost effective solution to maximise patient benefits and to minimise premature vision loss as a result of RVO."

"We are really pleased with this decision from NICE to recommend that suitable patients with RVO are treated with OZURDEX on the National Health Service. As with many other eye conditions, it is really important that RVO is treated as early as possible. Anyone noticing any change in their vision should have their eyes checked as soon as possible," said Barbara McLaughlan, Policy and Campaigns Manger for the Royal National Institute of Blind People (RNIB).

OZURDEX clinical data

The efficacy of OZURDEX was assessed in two 6-month, prospective, double-masked, parallel-group studies in which 1267 patients with macular oedema due to either branch or central retinal vein occlusion (BRVO or CRVO) were randomised to receive either OZURDEX or a sham (placebo) procedure. Clinically significant improvement in vision (defined as [greater than or equal to]15 letters or 3 lines on an eye chart) was seen after 2 months in up to 30% of patients with macular oedema due to RVO following just one injection of OZURDEX. In some patients this improvement was maintained for up to 6 months.[5] Importantly, up to 80% of patients had an improvement or no worsening in vision over the 6 months (defined as >0 letters on an eye chart).[6] The most frequently reported adverse reactions in patients who received OZURDEX(R) were increased intraocular pressure (24.0%) and conjunctival haemorrhage (14.7%).[7]

Notes to Editor

About Retinal Vein Occlusion

RVO is an important and common cause of vision loss,[8] affecting 5 in every 1,000 people over the age of 30.[9] It is estimated that more than 200,000 people suffer from RVO in the UK.[9,10]

RVO occurs when a retinal vein in the eye becomes blocked (occluded). [5] This blockage in the retinal vein leads to an inflammatory response, resulting in a build up of fluid in the retina and thickening of the macula (called macular oedema).[11] Macular oedema is a leading cause of vision loss in patients with RVO.[12,13] OZURDEX is the only approved medicine for the treatment of macular oedema in RVO. Other interventions include surgery and laser photocoagulation therapy, although these are not universally effective.[14,15] RVO can cause significant direct healthcare costs, as well as indirect costs to patients and society, such as loss of income and costs to adapt a person's home.[16,17]

About Macular Oedema Caused by Retinal Vein Occlusion (RVO)

Macular oedema is a common consequence of a number of retinal diseases, with inflammation playing a significant role.[3,8,18] Macular oedema is an excessive build up of fluid in the retina and thickening of the macula.[11] Macular oedema can lead to vision impairment if left untreated and it is the primary cause of vision loss in patients with branch RVO (occlusion in a branch retinal vein),[12] and is one of the leading causes of visual loss in patients with central RVO (occlusion in a central retinal vein).[13] Macular oedema is a common complication of diabetic retinopathy and is the leading cause of vision loss in patients with diabetes.[9] Uveitis can lead to macular oedema through an inflammatory process[19] and macular oedema is one of the main reasons for visual loss in uveitis.[20]

References

---------------------------------

[1] Deramo VA, Cox TA, Syed AB, et al. Vision-related quality of life in people with central retinal vein occlusion using the 25-item National Eye Institute Function Questionnaire. Arch Opthalmol 2003;121:1297-302.

[2] Data on File, Allergan, Inc.

[3] Kuppermann BD, Blumenkranz MS, Haller JA, et al. Randomized controlled study of an intravitreous dexamethasone drug delivery system in patients with persistent macular edema. Arch Ophthalmol 2007;125:309-17.

[4] Haller JA, Dugel P, Weinberg DV, et al. Evaluation of the safety and performance of an applicator for a novel intravitreal dexamethasone drug delivery system for the treatment of macular edema. Retina 2009;29:46-51.

[5] Haller JA, Bandello F, Belfort R et al. .Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology 2010,117:1134-46.

[6] Data on File 4B-65, Allergan, Inc.

[7] OZURDEX(R) Summary of Product Characteristics, July 2010.

[8] Royal College of Ophthalmologists. Retinal Vein Occlusion (RVO) Interim Guidelines. February 2009.

[9] Rogers S, McIntosh RL, Cheung N, et al. The prevalence of retinal vein occlusion: pooled data from population studies from the United States, Europe, Asia and Australia. Ophthalmology. 2010;121:1297-302.

[10] United Nations. World population prospects: the 2008 revision. Population database. Accessed 11 January 2010.

[11] Johnson MW. Etiology and treatment of macular edema. Am J Ophthalmol 2009;147:11-21.

[12] Margolis R, Singh RP, Kaiser PK. Branch retinal vein occlusion - clinical findings, natural history, and management. Compr Ophthalmol Update 2006;7:265-76.

[13] Weinberg , DV, Seddon JM. Venous occlusive diseases of the retina. In: DM Albert, FA Jakobiec. Principles and Practice of Ophthalmology. Philadelphia: WB Saunders Company,1994;2:735-46.

[14] The Branch Vein Occlusion Study Group. Argon laser photocoagulation for macular edema in branch vein occlusion. Am J Ophthalmol 1984;98:271-82.

[15] The Central Vein Occlusion Study Group M report. Evaluation of grid pattern photocoagulation for macular edema in central vein occlusion. Ophthalmology 1995;102:1425-33.

[16] Future Sight Loss UK (1): The economic impact of partial sight and blindness in the UK adult population. Executive summary. RNIB June 2009

[17] Lafuma A, Brezin A, Lopatriello S, et al. Evaluation of non-medical costs associated with visual impairment in four European countries. France, Italy, Germany and the UK. Pharmacoeconomics 2006;24:193-205.

[18] Tranos PG, Wickremasinghe SS, Stangos NT et al. Macular edema. Surv Opthalmol 2004;49;470-90.

[19] Forrester JV. Uveitis:pathogenesis. Lancet 1991;338:1498-501.

[20] Durrani OM, Tehrani NM, Marr JE et al. Degree, duration, and causes of visual loss in uveitis. Br J Opthalmol 2004;88:1159-62.