Allergan, Inc. (NYSE: AGN) (“Allergan” or the “Company”) today announced updates on three of the Company’s key R&D pipeline programs, including abicipar pegol (Anti-VEGF DARPin ® ), bimatoprost sustained-release implant for glaucoma and SEMPRANA™ (dihydroergotamine) inhalation aerosol (formerly referred to as LEVADEX ®). In addition, Allergan announced that it has received approval from the U.S. Food and Drug Administration (FDA) for OZURDEX ® (dexamethasone intravitreal implant) 0.7 mg as a treatment option for diabetic macular edema (DME) in adult patients who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic).
“Allergan has a long track record of delivering stockholder value by efficiently investing in R&D to provide important new treatment options to address unmet patient needs,” said David E.I. Pyott, Chairman and Chief Executive Officer, Allergan. “As a company that is well-known for industry leading R&D and innovation, we are pleased to announce the FDA approval of OZURDEX ®, which marks our 12 th FDA approval since 2010. In addition, we are pleased to share updates on several of our key R&D pipeline programs including abicipar pegol (Anti-VEGF DARPin ® ), which has been recognized as the most important value driver in our pipeline. With one of the most productive R&D pipelines in the industry, we are committed to advancing our R&D programs as we continue to deliver a steady stream of new treatments across the five specialty areas of our broad and balanced portfolio.”
Anti-VEGF DARPin ®
Allergan has completed the topline analysis of data from the Company’s Stage 3, Phase 2 study of abicipar pegol (Anti-VEGF DARPin ® ) in neovascular, or “wet,” age-related macular degeneration (AMD). These data along with data from previous studies were reviewed with the FDA at an end of a Phase 2 meeting where the FDA supported Allergan’s decision to advance abicipar pegol to Phase 3 clinical trials and agreed with the proposed Phase 3 study plan.The abicipar pegol Stage 3, Phase 2 study was designed to, in addition to assessing safety and efficacy, determine the appropriate dose of abicipar pegol that would provide equal or better visual acuity improvement but require less frequent injections than ranibizumab ( LUCENTIS ® ). In the double-masked trial, a total of 64 patients were randomized to abicipar pegol 1mg (n=25), abicipar pegol 2mg (n=23) or ranibizumab 0.5mg (n=16) and were followed for 20 weeks. All patients received doses at the start of the trial and at 4 and 8 weeks. Patients in the ranibizumab arm of the study received additional doses at 12 and 16 weeks. Patients who were treated with either dose of abicipar pegol received sham injections at 12 and 16 weeks. Patients in all arms of the study were well matched for demographics and baseline characteristics. The analysis of the topline data showed that after 16 weeks, mean visual acuity improvement from baseline was 8.2 letters for abicipar pegol 2mg, 6.3 letters for abicipar pegol 1mg, and 5.3 letters for ranibizumab. After 20 weeks, (12 weeks after the last abicipar injection and 4 weeks after the last ranibizumab injection) mean visual acuity improvement from baseline was 9.0 letters for abicipar pegol 2mg, 7.1 letters for abicipar pegol 1mg, and 4.7 letters for ranibizumab. In addition, Optical Coherence Tomography (OCT) data was supportive of the visual acuity data. 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 at the 2mg dose is at least as effective as monthly ranibizumab with a longer duration of action.