Aurion Biotech, whose mission is to restore vision to millions of patients with its life-changing regenerative therapies, today announced it has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its novel cell therapy, Vyznova™, for the treatment of bullous keratopathy of the cornea. The Company believes this is the first-ever regulatory approval in the world for an allogeneic cell therapy to treat corneal endothelial disease.
ONL Therapeutics Closes First Tranche of $15 Million Series C Financing to Advance Lead Compound into Phase 2 Clinical Trial
ONL Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced it has closed on the first tranche of a $15 million Series C Preferred Stock financing round. Proceeds from the financing will primarily support the advancement of ONL1204 Ophthalmic Solution into a Phase 2 clinical trial in patients with macula-off rhegmatogenous retinal detachment (RRD). We expect to initiate this new U.S.-based Phase 2 study in acute retinal detachment next quarter and to continue to generate data throughout the year from our two ongoing chronic Phase 1b studies in geographic atrophy (GA) associated with age-related macular degeneration and progressing open-angle glaucoma (OAG) that are being conducted in Australia and New Zealand.