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GenSight Gets Fast Track Designation For Optogenetic Therapy GS030 To Treat Retinitis Pigmentosa

GenSight Biologics (SIGHT), a company focused on developing and commercializing gene therapies, on Tuesday said the U.S. Food and Drug Administration or FDA has granted Fast Track Designation to GS030, which combines AAV2-based gene therapy with optogenetics to treat Retinitis Pigmentosa or RP.

The Fast Track designation granted by the FDA to GS030 highlights the significant unmet need for a safe and effective treatment of all forms of retinitis pigmentosa, the company said in a statement.

"Following the publication of a promising first case report in Nature Medicine in June, and with more data from the PIONEER trial expected later this year, we are in a great position in our quest to provide a cutting-edge treatment for retinitis pigmentosa patients," said Bernard Gilly, Co-Founder and Chief Executive Officer.

Fast Track is a process intended to facilitate the development and expedite the review of drugs for the treatment of serious conditions where there is an unmet medical need.

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