Skyline Therapeutics (Shanghai) Co. Ltd. has received FDA clearance for its IND application for a phase I/IIa trial of SKG-0106, a one-time intravitreally delivered recombinant adeno-associated virus (AAV) gene therapy for the treatment of neovascular age-related macular degeneration (wet AMD). A global phase I trial will be initiated soon.

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.

Drug Farm has received FDA clearance of its IND application for DF-003, a first-in-class, oral, potent, highly selective ALPK1 inhibitor.

Intergalactic Therapeutics Inc. has announced promising preclinical data with IG-002, its lead program addressing all forms of ABCA4-related retinopathies. Intergalactic’s nonviral gene therapy platform is designed to overcome limitations of standard adeno-associated virus (AAV) gene therapy technologies, including vector capacity limitations and vector-related safety concerns.

Visgenx Inc. has announced promising data from a nonhuman primate (NHP) study of VGX-011...

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).

Mutations in the CEP290 (NPHP6) gene cause severe cilia formation defects and a wide range of ciliopathies, ranging from non-syndromic Leber congenital amaurosis (LCA10) to Meckel syndrome (MKS). Researchers from Medetia SAS and affiliated organizations recently presented the discovery and preclinical evaluation of a novel prostaglandin-E2 receptor agonist, MDT-110, as a potential treatment of NPHP6/CEP290-associated phenotypes.

The U.S FDA 510(k) clearance for Corneat Vision Ltd.’s Everpatch is a “safety stamp” for the product, and the “first step’ in the deployment of Corneat’s synthetic tissue substitute technology, which could displace the use of donor and processed tissue, Almog Aley-Raz, CEO of Corneat, told BioWorld. The Corneat Everpatch, for use in ophthalmic surgeries, is the first non-degradable material that seamlessly embeds itself with surrounding tissue avoiding foreign body response often triggered by implanted devices, Aley-Raz claimed.