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FDA Grants Breakthrough and RMAT Status to Aurion’s AURN001
Aurion Biotech has been granted Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) Designation by the FDA for AURN001, Aurion’s innovative allogeneic cell therapy candidate designed to treat corneal edema secondary to corneal endothelial disease. Expediting Development and…
Oculis’ Licaminlimab Shows Promise in Phase 2B Trial for DED
Oculis Holding announced positive topline results from its phase 2b RELIEF trial, shedding light on the efficacy of licaminlimab, an innovative anti-TNFα biologic eye drop, in addressing dry eye disease (DED). Licaminlimab’s established dual mechanism of action, boasting both anti-inflammatory…
Metformin Found Ineffective Against Geographic Atrophy
In the quest to find effective treatments for eye diseases, the METformin for the MINimization of Geographic Atrophy Progression (METforMIN) trial sought to evaluate the efficacy of oral metformin in slowing the progression of geographic atrophy (GA) and its effects…
Nordic Pharma Introduces Lacrifill Canalicular Gel for Dry Eye
Nordic Pharma announced the commercial launch of Lacrifill Canalicular Gel, aimed at addressing dry eye disease in the United States. This novel therapy, Lacrifill, is a cross-linked hyaluronic acid derivative that has received clearance from the FDA. Its primary function…
J&J’s Nipocalimab Shows Promising Results in Sjögren’s Disease
Johnson & Johnson announced promising topline results from its Phase 3 VIVACITY study evaluating nipocalimab in adults with generalized myasthenia gravis (gMG), alongside findings from the Phase 2 DAHLIAS study in adults with Sjögren’s disease (SjD). Nipocalimab, an investigational treatment,…
Skye Bioscience’s Next Steps After Glaucoma Trial Disappointment
Skye Bioscience’s phase 2a clinical trial of its SBI-100 ophthalmic emulsion in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) has failed to meet its primary endpoint for lowering intraocular pressure (IOP). Consequently, the company announced its decision…
Melt Pharmaceuticals Launches MELT-300 Phase 3 Program
Melt Pharmaceuticals has completed the dosing of its first patient in its phase 3 program for MELT-300, marking a crucial step in evaluating the safety and efficacy of this pioneering product. MELT-300 is a non-intravenous, non-opioid tablet comprising fixed doses…
Rayner Announces 3 Key Appointments to Management Board
Rayner has made three key additions to its management board to foster continued growth and development within the organization. James Crutchlow has been appointed as Chief Commercial Officer, Rob Nadler as Chief Growth Officer, and Chris Willis as Chief Marketing…
Italy Probes Pharma Giants for Market Manipulation
Italy’s antitrust regulator has initiated a probe into several pharmaceutical giants, including Novartis, amid suspicions of anti-competitive practices in the sale of a drug targeting eye conditions. The investigation follows concerns regarding potential market restrictions and delayed product launch of…
BIOPHTA Secures €6.5M to Advance Eye Disease Therapy
BIOPHTA, a preclinical biotech company, has successfully closed a Seed round, raising €6.5 million to advance its pioneering technology into clinical development for the treatment of glaucoma and macular edema. This significant funding injection, led by prominent European venture capital…