Pharmaprojects R&D Pipeline News Feed
US approval for macular oedema implant
18 Jun 2009
The US FDA has approved Allergan's Ozurdex (dexamethasone) injectable biodegradable implant, for the treatment of macular oedema following branch retinal vein occlusion (RVO) or central retinal vein occlusion. Dexamethosone belongs to the glucocorticoid class of steroid hormones and is already widely-used in a variety of conditions, including as an anti-inflammatory, immunosuppressant and to mitigate the side-effects of chemotherapy.
The approval follows positive results from two Phase III efficacy trials across 1,300 patients as measured by improvement in best-corrected visual activity. A significant improvement was observed in 20-30% of patients within 2 months of implantation and this improvement was seen to persist for approximately 1-3 months.
Ozurdex offers the first intravitreally-administered therapy that provides prolonged efficacy and a favourable safety profile to patients with macular oedema. Allergen's Trivaris (triamcinolone) was approved in the US at the end of last year, also for the treatment of macular oedema associated with RVO.
US launch of Ozurdex is expected in the third quarter. It was previously launched in Singapore and Mexico in 1999, and is currently also in late-stage clinical trials in China and Israel.
