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Allergan Ltd announced today that the Committee for Medicinal Products for Human Use (CHMP) has recommended granting a Marketing Authorisation for ozurdex (dexamethasone drug delivery system [DEX-DDS]) in the 27 member states of the European Union.
If approved, ozurdex will become the first approved treatment in Europe for macular oedema in patients with retinal vein occlusion (RVO). Blockage (occlusion) in a retinal vein leads to an inflammatory response, resulting in macular oedema an excessive build up of fluid in the retina and thickening of the macula.
Retinal vein occlusion (RVO) is the second most common retinal vascular disease after diabetic retinopathy and is an important and common cause of vision loss.
“We are pleased with the decision reached by the Committee today to recommend ozurdex for Marketing Authorization in Europe, an important step in the regulatory review process and one step closer to offering patients suffering from macular oedema due to RVO this innovative treatment option,” said Mr David Endicott, President, Allergan Ltd, Europe, Africa and the Middle East.
“With 60-years of leadership and research investment into eye care, Allergan continues to pursue its strategic focus on the development of new treatments for the back of the eye which could help preserve vision for patients with certain retinal diseases.”
Ozurdex is a first-of-its-kind biodegradable intravitreal implant of dexamethasone, a highly potent corticosteroid, administered via a specially designed, single use applicator.
In two 6-month, prospective, double-masked, parallel-group studies, 1267 patients with macular oedema due to either branch or central retinal vein occlusion were randomised to receive either ozurdex or a sham (placebo) procedure.
Clinically significant improvement in vision (defined as ≥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.
Importantly, up to 85% of patients had an improvement or no worsening in vision over the 6 months (defined as >0 letters on an eye chart). The incidence of serious adverse events, such as increased intraocular pressure was similar between groups and they were, in the majority of cases, predictable and transient in nature.
The European Committee for Medicinal Products for Human Use (CHMP) is the scientific committee of the European Medicines Agency (EMEA) that recommends medicines for Marketing Authorization across 27 member states of the European Union. The European Commission generally follows the CHMP recommendation and grants final Marketing Authorization within a few months following a positive recommendation. Pending the final approval by the European authorities, Allergan anticipates launching ozurdex across the region starting in the third quarter of 2010.
