Applied Genetic Files IND For Its XLRS Product Candidate - Quick Facts

(RTTNews) - Applied Genetic Technologies Corp. (AGTC) announced it has filed an Investigational New Drug (IND) application with the U.S. FDA to conduct a Phase I/II clinical trial of the gene therapy product candidate for the treatment of X-linked retinoschisis. The company plans to initiate a clinical study evaluating the safety and efficacy of the gene therapy for treating XLRS during the second quarter of 2015 and expects to have initial data during the second half of 2015.

XLRS is an inherited retinal disease caused by mutations in the RS1 gene, which encodes the retinoschisin protein. AGTC's XLRS product candidate uses an AAV capsid with surface residues that have been specifically engineered for better penetration to the back of the eye.