Aerie Pharmaceuticals Announces Acceptance of Its IND Application for Sustained-Release Implant for Retinal Diseases
Aerie Pharmaceuticals announced that the FDA has reviewed the investigational new drug (IND) application for AR-13503, a novel multi-kinase (Rho kinase/Protein kinase C (ROCK/PKC)) inhibitor sustained-release implant, and it is now in effect, allowing Aerie to initiate human studies in the treatment of neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME).
The IND was submitted in March 2019. Aerie expects to initiate a first-in-human clinical study later in the second quarter of 2019.
The AR-13503 implant is a bio-erodible polyesteramide polymer implant that provides controlled release of AR-13503 over a sustained period. It is designed to be administered approximately once every 6 months by intravitreal injection. Preclinical studies suggest that AR-13503 has the potential to inhibit angiogenesis, preserve the blood retinal barrier, and reduce retinal fibrosis in retinal diseases such as wet AMD and DME, while potentially reducing 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,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer, said in a company news release. “The AR-13503 implant marks our second foray into the retina space, with this product candidate leveraging both our scientific leadership in the creation of small-molecule kinase inhibitors for disease intervention along with our proprietary ophthalmic drug delivery platform.”