Citing an unfavorable benefit-risk ratio, the FDA has declined to approve abicipar pegol for treatment of neovascular age-related macular degeneration.
A complete response letter to a biologics license application said the decision was due to the rate of intraocular inflammation observed after administration of abicipar pegol 2 mg/0.05 mL, an investigational DARPin therapy, according to a joint press release from Allergan and Molecular Partners.
The FDA advanced the application in September 2019. In 2018, the companies announced positive phase 3 study results, in which the drug met its primary
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