- Based on data from the GATHER2 phase III clinical trial, the FDA has approved an expanded label for IZERVAY™ for the treatment of geographic atrophy secondary to age-related macular degeneration.
- The decision provides greater flexibility in long-term disease management for physicians and patients.
- The treatment effect of avacincaptad pegol more than doubled in year 2 compared with year 1 in GATHER II.
- Reported adverse events include culture-positive endophthalmitis and nonserious intraocular inflammation. Choroidal neovascularization incidence was slightly higher with avacincaptad pegol treatment over 2 years.
- More than 210,000 vials were distributed between April 2024 and December 2024, and postmarketing safety data remains consistent with findings from clinical trials.
Source: Astellas