Sirion gets FDA Fast Track designation for sight-preserving drug

Sirion gets FDA Fast Track designation for sight-preserving drug
Tampa Bay Business Journal

Sirion Therapeutics Inc. announced positive results from a clinical trial evaluating a treatment for certain persons with macular degeneration.

The Phase II trial evaluated fenretinide as a treatment for geographic atrophy associated with age-related macular degeneration.

Sirion describes fenretinide as an oral vitamin A binding protein antagonist. Geographic atrophy is the most advanced form of dry age-related macular degeneration.

An analysis of the Phase II data showed slower growth of lesions in patients treated with oral fenretinide than in patients who received a placebo, a release from Sirion said.

Sirion will continue the Phase II study and will meet with scientific advisers and the Food and Drug Administration to design a Phase III study, the release said.

The effort by Sirion to develop fenretinide as a treatment got an additional boost when the FDA granted it Fast Track designation, the release said. Fast Track programs of the FDA are designated to facilitate the development of drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address an unmet medical need for such a condition.

Sirion is a privately held biopharmaceutical company based in Tampa focused on discovery, development and commercialization of products to protect and preserve eyesight.