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Allergan receives FDA complete response letter for wet AMD therapy
Safety concerns identified with injection treatment
The U.S. Food and Drug Administration (FDA) issued a complete response letter to the biologics license application for abicipar pegol, a novel, investigational designed ankyrin repeat proteins (DARPin) therapy for patients with neovascular (wet) age-related macular degeneration (nAMD), citing safety concerns.
In a statement, the FDA revealed that the rate of intraocular inflammation observed following administration of abicipar pegol 2 mg/0.05 mL results in an unfavorable benefit-risk ratio in the treatment of neovascular (wet) age-related macular degeneration (nAMD).
Allergan shared plans to meet with the FDA to discuss outcomes and establish next steps.
"We continue to believe in the need for treatment options that provide patients with reliable vision gains and less frequent dosing for the treatment of nAMD," said Michael R. Robinson, MD, vice president and global therapeutic area head of ophthalmology Allergan.
"We are committed to working with the FDA to determine the appropriate next steps for abicipar pegol," he says.
Roche’s Lucentis (ranibizumab) and Regeneron’s Eylea (aflibercept) are two major competitors in the treatment market for wet AMD.