Putting into jeopardy what was on track to be the first approved therapy in Europe for geographic atrophy (GA), an advanced form of age-related macular degeneration that causes blindness, Apellis Pharmaceuticals Inc. learned of a negative trend vote by the EMA’s Committee for Medicinal Products for Human Use (CHMP) on its MAA for intravitreal pegcetacoplan.
Inflammasome Therapeutics Inc. has received FDA clearance to begin a phase I/II trial of the company’s inflammasome inhibitor for the treatment of geographic atrophy, the most severe form of dry age-related macular degeneration. This is the first clinical trial of an inflammasome inhibitor to treat geographic atrophy. The company’s sustained-release implant contains the first of a new class of inflammasome inhibitor drugs, Kamuvudines, developed by the company and designed to halt the multiple processes that cause geographic atrophy.
Ray Therapeutics Inc. has been awarded a $4 million grant by the California Institute for Regenerative Medicine (CIRM) to help advance development of the company’s optogenetics technology platform and support progression of RTX-021 for the treatment of geographic atrophy, the advanced form of age-related macular degeneration.
Endogena Therapeutics Inc. has received FDA clearance of its IND application for EA-2351 for geographic atrophy, an advanced form of age-related macular degeneration (AMD).
Kriya Therapeutics Inc. has entered into an exclusive license, collaboration and supply agreement with Everads Therapy Ltd. to advance Kriya’s portfolio of gene therapies for retinal diseases using Everads’ suprachoroidal delivery device.
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.
Apellis Pharmaceutical Inc.’s shares nosedived by 37% July 17 after the American Society of Retina Specialists wrote to ophthalmologists warning them of the risk of serious intraocular inflammation events in patients following injection of the company’s geographic atrophy drug, Syfovre (pegcetacoplan).
On the strength of upside in best corrected visual acuity (BCVA) in patients with geographic atrophy (GA), Annexon Inc. officials will meet with the U.S. FDA to talk about what’s next for ANX-007, after the C1q inhibitor missed the phase II trial’s primary endpoint: mean rate of change, or slope, in the GA lesion area compared to sham.
