Novel protein may lead to extended intervals in AMD treatment

SAN DIEGO — Abicipar pegol, an engineered DARPin protein, shows promise for maintaining treatment gains at longer treatment intervals in patients with age-related macular degeneration, according to a speaker here.

“DARPins are a novel class of single-domain fusion proteins that can be engineered to selectively bind any given target protein with high affinity and specificity,” Raj K. Maturi, MD, said at the American Society of Retina Specialists meeting. “Abicipar pegol is the first engineered DARPin with a high affinity to soluble forms of VEGF-A.”

In the third stage of the phase 2 REACH study, a double-masked comparison of safety and treatment effects of abicipar pegol in treatment-naive exudative AMD, 25 patients received abicipar 1 mg and 23 patients received abicipar 2 mg at 4-week intervals for three loading doses. Patients were then followed up at 4-week intervals with sham to 20 weeks. In the comparator arm, Lucentis (ranibizumab, Genentech) 0.5 mg was given in 16 patients at each monthly visit.

Visual acuity improvement was numerically greater in the abicipar 2 mg group than in the ranibizumab group at 16 weeks — 8 weeks after the final abicipar injection — which was the primary endpoint. This greater numerical difference between treatments was sustained at week 20, Maturi said.

The study was not powered to show statistically significant differences between treatment groups, Maturi said, and no serious adverse events were observed.

Phase 3 studies beginning in 2015 will include an every 8-week and an every 12-week dosing schedule for abicipar, Maturi said.

Disclosure:Maturi receives research support from Alcon, Alimera, Allergan, Bayer, Eli Lilly, Eyegate, GlaxoSmithKline, Quark and Santen; he is a consultant for Allergan and Eli Lilly.