After this summer’s FDA approval of Iveric Bio’s Izervay—the drug at the center of the $5.9 billion buyout by Japanese pharma Astellas—the battle for the geographic atrophy (GA) crown is on in the U.S. Now, Apellis Pharmaceuticals, which boasts embedded eye disease sales leader Syfovre, is putting up long-term data in a bid to outdo its new rival.
Gaining FDA approval last month for its geographic atrophy (GA) drug Izervay put Astellas on a collision course with Apellis and its GA treatment Syfovre, which was endorsed by the U.S. regulator in February of this year.
PARSIPPANY, N.J.--(BUSINESS WIRE)--IVERIC bio, Inc. (Nasdaq: ISEE) announced today that top-line efficacy and safety results from GATHER2, the Company’s second Phase 3 clinical trial of avacincaptad pegol (ACP, also known as Zimura®), an investigational complement C5 inhibitor being evaluated for the treatment of geographic atrophy (GA), will be presented at the American Academy of Ophthalmology 2022 annual meeting (AAO 2022) in Chicago, September 30 – October 3. Following previously announced positive topline findings, this is the first time GATHER2 results for avacincaptad pegol will be presented at a medical congress.
A biotech has claimed a second Phase III win, and that company is taking its win all the way to the bank — and ultimately the FDA.
PARSIPPANY, N.J.--(BUSINESS WIRE)--Sep. 6, 2022-- IVERIC bio, Inc. (Nasdaq: ISEE) today announced positive topline results from GATHER2, the Company’s second Phase 3 clinical trial of Zimura® (avacincaptad pegol), a novel investigational complement C5 inhibitor, for the treatment of geographic atrophy (GA). GATHER2 met its prespecified primary endpoint of mean rate of growth (slope) in GA area at 12 months with statistical significance and a favorable safety profile.