Findings from 2 late-stage trials hint that abicipar pegol performs on par with ranibizumab for neovascular AMD, but requires half the injections.

Abicipar pegol is a VEGF-A inhibitor developed in collaboration with Molecular Partners. The recombinant protein’s small molecular weight enables higher concentrations and potentially longer intravitreal half-life than other anti-VEGF agents.

“Today’s anti-VEGFs were designed for monthly or bimonthly dosing. In the real world, patients have difficulty adhering to the schedule. The adopted treat-and-extend approach in certain cases shows suboptimal visual outcomes,” said Raj Maturi, MD, Midwest Eye Institute & Associate Professor, Ophthalmology, Indiana University School of Medicine. “Abicipar could be the first and only 12-week anti-VEGF treatment that improves visual outcomes in a real-world setting for a large number of AMD patients."

CEDAR and SEQUOIA were identical phase 3 trials designed to assess the efficacy and safety of abicipar in treatment-naïve AMD patients. Each multicenter study included 3 treatment arms: 2 mg abicipar pegol every 8 weeks, 2 mg abicipar pegol every 12 weeks, or 0.5 mg ranibizumab every 4 weeks.

Overall, greater than 90% of patients achieved stable vision after 52 weeks. Patients in the abicipar arms received an average of 6 to 8 injections, while those in the ranibizumab arm received 13 injections.

While rates of treatment-related adverse events were similar across groups, the incidence of intraocular inflammation was higher in the abicipar arms than in the ranibizumab arm (15% vs 0%).

Allergan anticipates filing for approval in 2019.