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AGTC files investigational NDA for X-linked retinitis pigmentosa gene therapy

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Applied Genetic Technologies Corporation has filed an investigational new drug application with the FDA to begin a phase 1/2 clinical trial of its gene therapy candidate for X-linked retinitis pigmentosa, according to a company press release.

X-linked retinitis pigmentosa, caused by mutations in the RPGR gene, is an inherited condition that causes progressive vision loss. In preclinical data, AGTC’s investigational gene therapy has slowed the loss of visual function in canines with X-linked retinitis pigmentosa, according to the release.

“We are deeply committed to advancing therapies to address the unmet needs of patients with rare inherited retinal disorders, and filing our fifth [investigational new drug application] in this field represents a significant milestone that may ultimately improve the lives of individuals affected by [X-linked retinitis pigmentosa],” Sue Washer, AGTC president and CEO, said in the release.