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DORC Receives FDA Clearance for Eva Nexus System
DORC International has announced 510(k) market clearance and the launch of the Eva Nexus. According to DORC, the Eva Nexus features multiple innovations to improve performance, efficiency, and stability for retina surgeons, including Smart IOP for anterior and posterior chamber stability; DORC’s trocar cannula system with HI-FLOW infusion…
Primary Open Angle Glaucoma (POAG)
A subtype of glaucomas known as primary open angle glaucoma (POAG) is characterized by an open, seemingly normal anterior chamber angle and elevated intraocular pressure (IOP), with no additional underlying disease. Secondary glaucoma is a condition where the elevated IOP…
Harrow Starts Triesence Relaunch Strategy
Harrow Pharmaceuticals announced its efforts to relaunch Triesence (triamcinolone acetonide injectable suspension) 40 mg/mL in the United States market. The company announced the successful manufacture of the first of three commercial-scale Process Performance Qualification (PPQ) batches required for the relaunch.…
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…