Aerie Pharmaceuticals has initiated a clinical trial of AR-13503, a sustained release implant, for treatment of neovascular age-related macular degeneration or diabetic macular edema, according to a press release.
The implant, which is made of bio-erodible polyesteramide polymer, is designed for once every 6-month dosing by intravitreal injection. The small molecule drug inhibits both Rho kinase and protein kinase C over a sustained period.
The first-in-human clinical trial will include two phases. The first, a multicenter, open label, dose escalation study, will evaluate the safety and tolerability of a single intravitreal injection of AR-13503 SR implant in two doses in 12 patients. The second phase, a multicenter, single-masked, randomized, parallel group study including up to 90 patients, will study AR-13503 SR’s safety and preliminary efficacy dosed as monotherapy and in combination with Eylea (aflibercept, Regeneron), compared with aflibercept alone, the release said.
“We are excited to be initiating human clinical evaluation of a novel treatment pathway for common, sight-threatening retinal diseases,” Vicente Anido Jr., PhD, Aerie chairman and CEO, said. “Because AR-13503 may address several distinct components of the disease process in nAMD and DME, we believe the AR-13503 SR implant has the potential to be an important addition to the treatment armamentarium in retina, particularly by helping expand the options for individualizing therapy.”