- In August 2023, Iveric Bio (now part of Astellas Pharma Inc.) received FDA approval for IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This approval marked a significant milestone, as IZERVAY is the only approved GA treatment demonstrated to slow GA progression by up to 35% in the first year of treatment across two Phase 3 clinical trials. This development provides a much-needed therapeutic option for a leading cause of irreversible vision loss
- In February 2023, Apellis Pharmaceuticals received FDA approval for SYFOVRE (pegcetacoplan injection), also for the treatment of geographic atrophy (GA) secondary to AMD. This made SYFOVRE the first-ever FDA-approved treatment for GA. Clinical trials showed that SYFOVRE could slow the progression of GA by 14% to 20%. This approval created a new class of treatments for a previously untreatable condition, addressing a significant unmet medical need for millions of patients
- In May 2023, Bausch + Lomb and Novaliq GmbH announced the FDA approval of MIEBO (perfluorohexyloctane ophthalmic solution) for the treatment of the signs and symptoms of dry eye disease (DED). MIEBO is notable as the first and only FDA-approved prescription eye drop that directly targets tear evaporation, which is a major contributor to DED. This approval introduces a novel mechanism of action to the dry eye market, which is experiencing significant growth
- In July 2023, Tarsus Pharmaceuticals, Inc. received FDA approval for XDEMVY (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis. This marked the first and only FDA-approved treatment specifically for this common eyelid inflammation caused by Demodex mites. The approval was based on clinical trials where patients treated with XDEMVY showed significant improvement in eyelid collarettes (a key sign of Demodex infestation)
