FDA approves Ozurdex

Allergan, Inc., announced that it has received FDA approval for Ozurdex (dexamethasone intravitreal implant) 0.7 mg for diabetic macular edema (DME) in pseudophakic patients or phakic patients scheduled for cataract surgery.

Ozurdex is a sustained-release biodegradable steroid implant. It uses the company’s proprietary Novadur solid polymer delivery system‑a biodegradable implant that releases medicine over an extended period of time‑to suppress inflammation

Ozurdex also is FDA-approved for macular edema following branch retinal vein occlusion or central retinal vein occlusion and for posterior uveitis.

Allergan also announced the completion of topline analysis of data from its stage 3, phase 2 study of abicipar pegol (Anti-VEGF DARPin) for wet AMD. Although the study was not powered to show statistically significant differences between treatment groups and further data will be completed and submitted to the FDA, these data suggest that abicipar 2 mg is at least as effective as monthly ranibizumab, with a longer duration of action.

Allergan will initiate phase 3 studies of abicipar pegol in the second quarter of 2015, when material from its new manufacturing process for abicipar is available. In the phase 3 program, the company will compare abicipar 2 mg dosed every eight weeks, abicipar 2 mg dosed every 12 weeks and ranibizumab dosed every four weeks.

Allergan also announced that it plans to start phase 3 clinical trials by the end of the year for bimatoprost sustained-release implant for glaucoma and elevated IOP.

The results of its phase 2 study, in which patients received a bimatoprost sustained-release implant in one eye and topical bimatoprost in the contralateral eye, suggest that bimatoprost sustained-release implant efficacy is comparable to daily topical bimatoprost and lasts for four to six months.