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).
Galimedix Therapeutics Inc. plans to move its lead compound, GAL-101, into a phase IIa proof-of-concept trial next year, in order to test an intriguing hypothesis associated with certain retinal degeneration conditions. GAL-101 selectively binds misfolded amyloid beta species, and the company believes that this mechanism may benefit patients with the dry form of age-related macular degeneration or with glaucoma.
Pharmabcine Inc. has received IND approval from the Korean Ministry of Food and Drug Safety (MFDS) to initiate a phase I trial of PMC-403 in Korea in subjects with neovascular (wet) age-related macular degeneration (AMD).
Touting what’s been so far the “cleanest safety profile that’s been presented with genetic medicine in the eye,” deemed “a game changer for this field,” 4D Molecular Therapeutics Inc. CEO David Kirn said phase III planning will begin in later this year to test gene therapy 4D-150 in wet age-related macular degeneration (AMD).
Complement Therapeutics GmbH raised €72 million (US$79.4 million) in a series A round to move into the clinic a novel gene therapy for treating geographic atrophy secondary to dry age-related macular degeneration. It’s the largest series A round completed in Europe so far this year.
The granting of breakthrough device designation from the U.S. FDA to Pixium Vision SA for its Prima system was a boon for the company as its share price jumped more than 300% following the news. The price increase was “validation from the public market and investors” that the Prima system, for dry age-related macular degeneration (AMD), has the potential to get regulatory approval, Lloyd Diamond, CEO of Pixium, told BioWorld.
Thirona BV spun out its retina division into a stand-alone business, Thirona Retina BV, focused exclusively on the eye disease market, effective Jan. 1, 2023. The development comes after the recent expansion of Retcad, Thirona’s flagship solution for eye disease screening. Thirona BV will continue to develop artificial intelligence (AI)-driven systems for precision medicine in lung disease.
Exegenesis Bio (Hangzhou Exegenesis Biotechnology Co. Ltd.) has received FDA clearance of its IND application for EXG-102-031, a recombinant adeno-associated virus (rAAV)-based gene therapy that is being studied for the treatment of neovascular age-related macular degeneration (AMD).
