Zimura receives breakthrough therapy designation for geographic atrophy
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The FDA has granted breakthrough therapy designation to Zimura for the treatment of geographic atrophy secondary to age-related macular degeneration, according to a press release from Iveric Bio.
Zimura (avacincaptad pegol), a complement C5 inhibitor, is the first investigational therapy to receive the status of breakthrough therapy designation for this indication. The designation is based on positive 12-month primary efficacy endpoint data from the GATHER1 and GATHER2 pivotal clinical trials, which demonstrated observed efficacy rates of up to 35% (P = .0050 for GATHER1) and 18% (P = .0039 for GATHER2) compared with sham and 28% (P = .0063 for GATHER1) and 14% (P = 0.0064 for GATHER2) using square root transformation.
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There were no reports of serious intraocular inflammation, vasculitis or endophthalmitis in either trial.
“In both GATHER1 and GATHER2, avacincaptad pegol consistently showed a treatment effect with the first measurement at month 6 that was persistent and continued to increase over time, with observed efficacy rates of up to 35%,” Pravin U. Dugel, MD, president of Iveric Bio, said in the release. “We believe [avacincaptad pegol] has the potential to safely and effectively preserve central vision by saving photoreceptor cells for patients living with this life-changing disease that leads to irreversible blindness.”
Iveric Bio expects to complete the final part of its new drug application submission for avacincaptad pegol by the end of the year.
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