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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…

Teprotumumab Shows Long-Lasting Benefits for TED Patients

Research presented at ENDO 2024, the Endocrine Society’s annual meeting in Boston, Massachusetts, and published in the journal Thyroid, indicates that most patients with thyroid eye disease (TED) treated with teprotumumab did not require additional treatments nearly two years later.…

Beacon Therapeutics Initiates VISTA Trial for X-Linked RP

Beacon Therapeutics announced the treatment of the inaugural patient in its pivotal VISTA clinical trial with its lead asset, AGTC-501 (laruparetigene zovaparvovec), marking a significant advancement in the pursuit of combating X-Linked Retinitis Pigmentosa (XLRP). Objective of the VISTA Trial…

Robot Radiotherapy Could Improve Treatment for AMD

Researchers from King’s College London, in collaboration with doctors at King’s College Hospital NHS Foundation Trust, have achieved a breakthrough in treating a debilitating eye disease using a new robot system. This system targets wet neovascular age-related macular degeneration (AMD)…

Australia’s 2nd Generation Bionic Eye Shows Promise in RP

Australia’s second-generation bionic eye has demonstrated “substantial improvement” in functional vision, daily activities, and quality of life for four participants over a period of more than two and a half years, according to the results of the first clinical trial.…

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…

Harrow Reveals 52-Week Data for Vevye ESSENCE-2 Study

Harrow, a leading pharmaceutical company, has revealed the encouraging results from its ESSENCE‑2 open-label extension (OLE) clinical study for Vevye (cyclosporine ophthalmic solution) 0.1%, a novel treatment for dry eye disease (DED). Study Design and Outcomes: ESSENCE-2 OLE Analysis The…

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