Abicipar pegol not approved for treatment of wet AMD
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 endpoints but saw higher rates of intraocular inflammation in about 15% of patients. The subsequent MAPLE study results reported a lower rate of intraocular inflammation, 8.9%, which was credited to a modified manufacturing process.
“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 [neovascular] AMD,” Michael R. Robinson, MD, vice president, global therapeutic area head, ophthalmology, at AbbVie, Allergan’s parent company, said in the release. “We are committed to working with the FDA to determine the appropriate next steps for abicipar pegol.”