Complete Response for abicipar pegol to treat neovascular (wet) age-related macular degeneration. Allergan/AbbVie + Molecular Partners .

Allergan, an AbbVie Company and Molecular Partners a clinical-stage biotechnology company developing a new class of custom-built protein therapeutics known as DARPin therapeutics, announced that the FDA has issued a Complete Response Letter to the Biologics License Application (BLA) for Abicipar pegol, a novel, investigational DARPin therapy for patients with neovascular (wet) age-related macular degeneration (nAMD).

The letter from the FDA indicates that the rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit-risk ratio in the treatment of neovascular (wet) age-related macular degeneration (AMD). AbbVie plans to meet with the FDA to discuss their comments and determine next steps.