1. May 23, 2019

FDA Accepts Investigational New Drug Application for Sustained-Release Implant for Retinal Diseases

The U.S. Food and Drug Administration (FDA) has reviewed the Investigational New Drug (IND) application for AR-13503, a new multi-kinase (Rho kinase/Protein kinase C [ROCK/PKC]) inhibitor sustained-release implant (the AR-13503 implant), clearing the path for human clinical studies in the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), according to a press release from Aerie Pharmaceuticals, Inc.

The AR-13503 implant is a bio-erodible polyesteramide polymer implant that provides controlled release of AR-13503 and is administered by intravitreal injection approximately once every 6 months.

The implant has the potential to inhibit angiogenesis, preserve the blood retinal barrier, and reduce retinal fibrosis in retinal diseases, such as nAMD and DME, according to the results of preclinical studies. It may also lessen the treatment burden associated with more frequent intravitreal injections.

“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,” said Vicente Anido, Jr, PhD, Chairman and Chief Executive Officer.

Aerie expects to initiate a first-in-human clinical study in the second quarter of 2019.

You can read more here.