FDA Approves Iveric Bio’s New Geographic Atrophy Treatment

Image Credit: Adobe Stock Images/Ольга Тернавская

Iveric Bio, an Astellas company, has officially announced the FDA approval of Izervay (avacincaptad pegol intravitreal solution), indicated for the treatment of geographic atrophy (GA). Currently, the C5 inhibitor is the only approved GA treatment with a statistically significant reduction (p<0.01) in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials. According to a company press release, the trials showed disease progression slowed as early as six months.

"We are thrilled to receive FDA approval of Izervay and to offer a new therapy to physicians and appropriate patients in the U.S. Time matters, vision matters, and safety matters in this devastating progressive disease,” said Pravin U. Dugel, MD, President, Iveric Bio, in the company release. We would like to thank everyone involved in reaching this milestone and helping us deliver on our commitment to pioneer transformational therapies for retinal diseases."

Reference: Iveric Bio Receives U.S. FDA Approval for IZERVAY™ (avacincaptad pegol intravitreal solution), a New Treatment for Geographic Atrophy. PR Newswire. August 4, 2023. Accessed August 8, 2023. https://www.prnewswire.com/news-releases/iveric-bio-receives-us-fda-approval-for-izervay-avacincaptad-pegol-intravitreal-solution-a-new-treatment-for-geographic-atrophy-301894042.html