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.
Santen Pharmaceutical Co. Ltd. is selling its North American branded ophthalmic portfolio to Visiox Pharma LLC and Harrow Health Inc. in a move to make its global organization as competitive as possible, Santen told BioWorld.
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).
Tenpoint Therapeutics Ltd. raised $70 million in a series A funding round to pursue ambitious plans to reverse vision loss using both ex vivo cell engineering and in vivo cell reprogramming approaches.
As investors continue to weigh VRDN-001’s chances against Tepezza (teprotumumab, Horizon Pharmaceuticals plc) in thyroid eye disease, Viridian Therapeutics Inc. popped the lid off positive preliminary data from the ongoing phase I/II trial with the intravenous full antagonist antibody to the insulin-like growth factor 1 receptor.
Astellas Pharma Inc. and 4D Molecular Therapeutics Inc. (4DMT) inked a deal worth up to $942 million under which Astellas will license 4DMT's intravitreal R100 gene therapy vector for rare ophthalmic targets.
Just over a month after scoring U.S. FDA clearance for dry eye disease therapy Miebo (perfluorohexyloctane), Bausch + Lomb Corp. is adding Xiidra (lifitegrast) to its arsenal in the same indication as part of the potential $2.5 billion deal with Novartis AG, which is divesting its “front-of-eye” ophthalmology assets.
Japan’s Pharmaceutical and Medical Devices Agency has cleared Healios K.K. and Sumitomo Pharma Co. Ltd. to begin a phase I/II study of HLCR-011, which is composed of retinal pigment epithelial (RPE) cells derived from allogeneic induced pluripotent stem cells (iPS) in patients with RPE tear.
Less than two years old, Tourmaline Bio Inc. is gaining a public listing through a reverse merger with publicly traded Talaris Therapeutics Inc., as it enters a phase IIb with its lead IL-6 inhibitor for thyroid eye disease (TED).
The lead asset of Applied Genetic Technologies Corp. has been spun into Beacon Therapeutics Ltd., which launches with $120.9 million to run a phase II/III pivotal trial of AGTC-501 in X-linked retinitis pigmentosa, and to take forward two other in-licensed preclinical programs in age-related macular degeneration and cone rod dystrophy.