The U.S. FDA issued a complete response letter Nov. 15 for Izervay’s (avacincaptad pegol intravitreal solution, ACP) supplemental NDA, which sought to include positive two-year data for the Astellas Pharma Inc. therapy, previously approved for use in a treatment for geographic atrophy secondary to age-related macular degeneration.
Iveric Bio Inc.’s regulatory win Aug. 4 drew attention to the already hot eye-disease space, where intriguing new developments include the possibility of an oral therapy for Stargardt disease. Belite Bio Inc. in late July finished enrollment of a phase III study with once daily tinlarebant, a retinol binding protein 4 antagonist for Stargardt’s. Data from 90 adolescent subjects in the study called Dragon are due in mid-2024.
Iveric Bio Inc. is now the second biotech to gain U.S. clearance for geographic atrophy – snagging U.S. FDA approval on Aug. 4 for Izervay (avacincaptad pegol intravitreal solution) to treat GA secondary to age-related macular degeneration. The once-monthly Izervay 2-mg injection is anticipated to be available in the U.S. in two to four weeks, said Tokyo-based Astellas Pharma Inc., which recently acquired Iveric in May 2023.
Iveric Bio Inc. is now the second biotech to gain U.S. clearance for geographic atrophy – snagging U.S. FDA approval on Aug. 4 for Izervay (avacincaptad pegol intravitreal solution) to treat GA secondary to age-related macular degeneration. The once-monthly Izervay 2-mg injection is anticipated to be available in the U.S. in two to four weeks, said Tokyo-based Astellas Pharma Inc., which recently acquired Iveric in May 2023.
Astellas Pharma Inc. announced it plans to acquire Iveric Bio Inc. in an all-cash deal in which it will pay $40 per Iveric share for a total equity value of roughly $5.9 billion. “Iveric Bio has promising programs including avacincaptad pegol (Zimura), an important program for geographic atrophy secondary to age-related macular degeneration, and capabilities across the entire value chain in the ophthalmology field,” said Naoki Okamura, Astellas’ president and CEO.
Astellas Pharma Inc. announced it plans to acquire Iveric Bio Inc. in an all-cash deal in which it will pay $40 per Iveric share for a total equity value of roughly $5.9 billion. “Iveric Bio has promising programs including avacincaptad pegol (Zimura), an important program for geographic atrophy secondary to age-related macular degeneration, and capabilities across the entire value chain in the ophthalmology field,” said Naoki Okamura, Astellas’ president and CEO.
Questioners probed the fine points during Iveric Bio Inc.’s conference call, but news proved unmistakably good with Zimura (avacincaptad pegol) in geographic atrophy (GA), and shares of the firm (NASDAQ:ISEE) closed Sept. 6 at $15.70, up $6.26, or 66%, on positive top-line data from Gather 2, the firm’s second phase III study.
The phase III miss disclosed Aug. 11 by Kubota Pharmaceutical Holdings Co. Ltd. subsidiary Kubota Vision Inc. in Stargardt disease put more eyes on the rare, inherited, juvenile-onset form of macular degeneration, for which nothing is approved.
Apellis Pharmaceuticals Inc.’s win with one phase III trial and narrow miss with an identical one testing pegcetacoplan in geographic atrophy secondary to age-related macular degeneration caused Wall Street to punish the company while rewarding competitor Iveric Bio Inc.
LONDON – In the rush to test drugs against COVID-19, clinical trials in other indications are starting to be interrupted by the strains on health care systems and the fact that many potential patients are those most at risk from the effects of the novel coronavirus.
