Allergan Gets FDA Approval For Ozurdex, Announces R&D Pipeline Update

(RTTNews) - Allergan, Inc. (AGN) Monday said the U.S. Food and Drug Administration or FDA has approved Ozurdex 0.7 mg as a treatment option for diabetic macular edema in adult patients who have an artificial lens implant or who are scheduled for cataract surgery. In addition, the company received a Complete Response Letter from the FDA to its New Drug Application for Semprana, formerly referred to as Levadex, which is being developed as an acute treatment of migraine in adults. The firm announced updates on three of the its key R&D pipeline programs, including Anti-VEGF DARPin, bimatoprost sustained-release implant for glaucoma and Semprana inhalation aerosol.

Allergan has finished the topline analysis of data from its's Stage 3, Phase 2 study of Anti-VEGF DARPin in neovascular, or 'wet,' age-related macular degeneration. These data along with data from previous studies were reviewed by the FDA at an end of a Phase 2 meeting where the FDA backed Anti-VEGF DARPin's advance to Phase 3 clinical trials and agreed with the proposed Phase 3 study plan. The company said it will initiate Phase 3 studies in the second quarter of 2015, when material from the new manufacturing process is available. Further the company said it has shared the bimatoprost sustained-release implant data with the FDA. The Phase 3 clinical trials will be initiated by the end of 2014.