According to the company, the MAA submission is based on data from the GATHER1 and GATHER2 Phase III clinical trials.
Astellas Pharma Inc. announced the European Medicines Agency (EMA) has accepted for regulatory review the marketing authorization application (MAA) for Iveric Bio’s avacincaptad pegol (ACP).
According to the company, ACP is an investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The Committee for Medicinal Products for Human Use (CHMP) of the EMA will start its review of the MAA under the centralized licensing procedure for all 27 member states of the European Union (EU).
The company noted that ACP met its primary endpoint in the GATHER1 (NCT02686658) clinical trial and the GATHER2 (NCT04435366) clinical trial, both of which were randomly assigned, double-masked, sham-controlled, multicenter Phase 3 clinical trials.
The MAA is based on the GATHER1 and GATHER2 Phase 3 clinical trials, which evaluated the safety and efficacy of monthly 2 mg intravitreal administration of ACP in patients with GA secondary to AMD. In each registrational trial, over a 12-month period, the primary analysis showed a statistically significant reduction in the rate of GA growth in patients treated with ACP compared to sham. Across the GATHER1 and GATHER2 clinical trials, safety was evaluated in over 700 patients with GA.
Moreover, the company noted the trials evaluated the safety and efficacy of monthly 2 mg intravitreal administration of ACP in patients with GA secondary to AMD. For the first 12 months in both trials, patients were randomized to receive either ACP 2 mg or sham monthly. There were 286 participants enrolled in GATHER1 and 448 participants enrolled in GATHER2. The primary efficacy endpoints in both pivotal studies were based on GA area measured by fundus autofluorescence at three time points: baseline, month 6, and month 12. Safety was evaluated in over 700 patients with GA across the trials.
GA is a form of AMD that can cause irreversible vision loss.1 Without timely treatment, an estimated 66% of people with GA may become blind or severely visually impaired.2 Globally, approximately 5 million people are estimated to have GA at least in one eye.1
“This acceptance of our EU Marketing Authorization Application is a key milestone in our global effort to help patients living with GA, a leading cause of blindness worldwide. We look forward to collaborating with CHMP throughout the review process and hope to make ACP available for patients in Europe,” Pravin U. Dugel, president of Iveric Bio, an Astellas company, said in a statement.
According to the news release, ACP was approved by the FDA as IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy secondary to age-related macular degeneration on August 4, 2023.
“Time matters, vision matters, and safety matters in this devastating progressive disease,” Dugel said in the statement upon receiving the FDA approval. “We would like to thank everyone involved in reaching this milestone and helping us deliver on our commitment to pioneer transformational therapies for retinal diseases."
Jason Menzo, CEO of Foundation Fighting Blindness, noted the treatment could go a long way to improve the quality of life of patients diagnosed with GA.
"Geographic atrophy can severely limit people's ability to drive, read, and see the faces of their family and friends,” he said in the release. “This new treatment offers our patient community an important therapeutic option to potentially extend their ability to maintain independence."
The approval is the second for a drug for geographic atrophy, coming on the heels of pegcetacoplan injection (SYFOVRE, Apellis Pharmaceuticals) in February. In July, Astellas Pharma completed its $5.9 billion acquisition of Iveric Bio.
This acceptance of the EU Marketing Authorization Application will have no impact on the financial forecasts of the current fiscal year ending March 31, 2024.