Astellas Pharma US, Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced positive 24-month topline results from the Phase 3 GATHER2 clinical trial evaluating the efficacy and safety of IZERVAY™ (avacincaptad pegol intravitreal solution), a complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Topline results demonstrated that the IZERVAY monthly dosing regimen met the primary objective to significantly slow GA growth compared to sham at 24 months. Additionally, the treatment effect with the every other month dosing regimen for IZERVAY showed a similar reduction in the rate of GA growth versus sham.
Overall, safety after 24 months of treatment was consistent with previously reported 12-month data, with no new safety signals identified. There was one case of culture-positive endophthalmitis and one case of non-serious intraocular inflammation. There were no cases of occlusive or non-occlusive retinal vasculitis or ischemic neuropathy. The rate of choroidal neovascularization (CNV) was 12% in patients treated with IZERVAY and 9% in those treated with sham.
Dhaval Desai, PharmD, Senior Vice President and Chief Development Officer, Iveric Bio, An Astellas Company
"We are excited about these results, which show that IZERVAY continued to slow the rate of GA growth with a consistent safety profile after two years of treatment. We look forward to sharing results at a future scientific congress and with regulatory agencies."
IZERVAY was approved by the U.S. Food and Drug Administration on August 4, 2023, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) and is currently under review by the European Medicines Agency.
Astellas is reviewing potential financial impacts of these results for the fiscal year ending March 31, 2024.
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