The FDA has accepted Aerie Pharmaceuticals’ investigational new drug application for the AR-13503 implant, the company’s treatment candidate for neovascular age-related macular degeneration and diabetic macular edema, the company announced in a press release.
A first-in-human clinical study is planned to begin in the second quarter of this year.
The bio-erodible polyesteramide polymer implant, which delivers a controlled, sustained release of the Rho kinase/protein kinase C inhibitor AR-13503, is designed to be administered by intravitreal injection every 6 months, the release said.
“While the standard-of-care anti-VEGF therapies are effective for many patients with nAMD and DME, there are many patients who do not respond adequately to these therapies or who lose their initial gains in vision over time. By targeting multiple disease processes that underlie progression in these common, sight-threatening retinal diseases, our research suggests that ROCK/PKC inhibitors such as AR-13503 may prove useful as alternative or additive therapies to the currently available treatments,” Aerie chairman and CEO Vicente Anido Jr, PhD, said.