Astellas Pharma Inc. announced that the U.S. Food and Drug Administration approved an expanded label for IZERVAY™ (avacincaptad pegol intravitreal solution), that removes limitations on the duration of dosing 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 FDA's decision follows Astellas' resubmission of a supplemental New Drug Application on December 26, 2024, shortly after discussions with the agency to address a Complete Response Letter issued in November 2024.
"This is a welcome update for retina specialists, providing continued management options for treatment of this chronic, progressive disease that can lead to irreversible vision loss," said Veeral S. Sheth, MD, MBA, FACS, FASRS, partner and director of clinical trials at University Retina, in Astellas’ press release.
The GATHER2 phase III clinical trial served as the basis for the FDA’s expanded approval. The trial demonstrated that avacincaptad pegol significantly slowed geographic atrophy lesion growth over 2 years vs sham. Treatment benefits were observed as early as 6 months and continued to increase over time. Notably, the treatment effect more than doubled in year 2 compared with year 1.
Avacincaptad pegol was well tolerated through 2 years with minimal safety concerns. Reported adverse events included:
- 1 case of nonserious intraocular inflammation
- 1 case of culture-positive endophthalmitis
- 0 cases of ischemic optic neuropathy or serious intraocular inflammation (including retinal vasculitis)
- Choroidal neovascularization incidence, which was slightly higher in the avacincaptad pegol group (11.6%) vs sham (9%) over 2 years.
Between receiving a permanent J-code in April 2024 and December 2024, more than 210,000 vials were distributed. Postmarketing safety data remains consistent with findings from clinical trials.
