Actavis plc (NYSE: ACT) has announced receipt of communication from the UK National Institute for Health and Care Excellence (NICE) indicating support for the use of Ozurdex (dexamethasone 0.7mg intravitreal implant) in patients suffering diabetic macular edema (restricted to pseudophakic patients who do not respond to non-costicosteroid treatment). The medication is currently approved in the EU for macular edema following either branch or central retinal vein occlusion and for the treatment of non-infectious posterior segment uveitis. Subject to a Final Appraisal Determination from NICE, the medication may become available under the NHS in England and Wales for suitable patients with diabetic macular edema (DME).
DME is one of the main causes of mild to moderate vision loss in diabetic retinopathy and is characterized by an abnormal accumulation of extravascular fluid in the central retina arising from a breakdown of the blood-retinal barrier. It has been estimated that up to 14% of type-2 diabetic patients who are not on insulin treatment will develop DME. Ozxurdex is marketed by Actavis as a “first-of-its-kind” biodegradable intravitreal implant containing the corticosteroid, dexamethasone – a treatment shown to inhibit inflammation, known to represent a significant underlying cause of macular edema. The implant contains 700ug of dexamethasone inside a solid copolymer drug delivery implant. Once inserted intravitreally, the implant, made of lactic acid and glycolic acid degrades slowly into carbon dioxide and water releasing the dexamethasone directly into the eye as it does so. As a result no surgical removal is required. According to Allergan (recently acquired by Actavis), the system releases “an initial high-pulse dose of dexamethasone directly to the retina over 2 months, followed by controlled, gradual release for up to 6 months, avoiding the need for frequent repeat intravitreal injections, which can have potential complications and impact on patients quality of life”.
Commenting on the milestone, Mr Ian Pearce, a consultant ophthalmologist at St Paul’s Eye Unit, Royal Liverpool University Hospital, stated in a company press release, “I am pleased to have a NICE recommended treatment option for some of my patients with DMO. However, for those who still have their natural lens and who remain excluded from this guidance – specifically those who have not responded to, or are unsuitable for, non-corticosteroid therapy, I do hope to see the funding extended.”