Allergan (AGN -1.5%) holds a conference call this morning to update investors on three of its pipeline programs.
Anti-VEGF DARPin: Completed top-line analysis of a Phase 2 study of abicipar pegol in wet age-related macular degeneration (AMD) and reviewed with the FDA. The program will now proceed to a Phase 3 clinical trial. The primary objective in the Phase 2 was to determine the appropriate dose of abicipar pegol that would provide equal or better visual acuity improvement compared to Luncentis (ranibizumab) but require less frequent injections.
Bimatoprost Sustained Release Implant: Reviewed Phase 2 clinical trial data assessing it as a treatment for elevated intraocular pressure and glaucoma. Patients in the study received the implant in one eye and topical bimatoprost in the other eye. The data suggests that results with the implant are comparable to the topical version over 4 - 6 months.
Semprana (dihydroergotamine): CRL received from FDA pertaining to the specifications around content uniformity on the improved canister filling process and standards for device actuation. The company plans to meet with the agency as it addresses these issues. The next FDA action will not occur until probably late Q2 2015, however.
The FDA approved Ozurdex (dexamethasone intravitreal implant) for the treatment of diabetic macular edema (DME) in patients who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic). Ozurdex is a sustained-release biodegradable steroid implant whose long-efficacy eliminates the need for monthly injections.