JUL 23, 2018
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 sub-optimal 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.