Aerie Pharmaceuticals announced the commencement of patient dosing in a first-in-human clinical trial of AR-13503 Sustained Release (SR) implant in patients with neovascular age-related macular degeneration (AMD) or diabetic macular edema (DME).
This multi-arm, 24-week study (AR-13503-CS201) is being conducted in two sequential stages. The first phase is a multicenter, open label, dose escalation study of the safety and tolerability of a single intravitreal injection of AR-13503 SR Implant, using two doses, in up to 12 patients. The second phase, enrolling up to 90 patients, is a multicenter, single-masked, randomized, parallel group study of the safety and preliminary efficacy of low- or high-dose AR-13503 SR Implant, dosed as monotherapy and in combination with aflibercept (Eylea; Regeneron), compared to aflibercept alone. Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor approved for the treatment of retinal diseases.
More information about the study is available at www.clinicaltrials.gov under the study designation NCT03835884.
“We are excited to be initiating human clinical evaluation of a novel treatment pathway for common, sight-threatening retinal diseases,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer, said in a company news release. “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. This study is designed to confirm our preclinical observations that AR-13503 could be useful as either monotherapy or in combination with VEGF inhibitors, and to help us select an appropriate dose for later stage trials. It will also provide the first clinical data for our polyesteramide bio-erodible polymer implant technology, which allows us to deliver small-molecule drugs to the back of the eye while extending treatment duration.”
About AR-13503 SR Implant
The AR-13503 SR Implant is a bio-erodible polyesteramide polymer implant that provides controlled release of AR-13503, a proprietary, small-molecule inhibitor of both Rho kinase and Protein kinase C, over a sustained period. It is designed to be administered approximately once every 6 months by intravitreal injection. Preclinical studies suggest that AR-13503 may inhibit angiogenesis, preserve the blood retinal barrier, and reduce retinal fibrosis in retinal diseases such as nAMD and DME, while potentially reducing the treatment burden associated with more frequent intravitreal injections.