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Saturday / May 21.
HomeminewsOral Therapy for STGD1 Receives FDA Fast Tract Designation

Oral Therapy for STGD1 Receives FDA Fast Tract Designation

LBS-008, an oral therapy for Stargardt disease (STGD1), by Belite Bio, Inc, a clinical stage biopharmaceutical drug development company, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA).

LBS-008 is a novel oral therapy that prevents the build-up of toxins in the eye that cause STGD1 and contribute to dry age-related macular degeneration (AMD). By modulating the amount of retinol entering the eye, Belite Bio says LBS-008 reduces the formation of toxins which have been implicated in STGD1 and dry AMD in order to maintain the health of retinal tissues.

The Fast Track Designation process, designed to facilitate the development, and expedite the review of drugs, will provide patients with earlier access to LBS-008

The Fast Track Designation process, designed to facilitate the development, and expedite the review of drugs, will provide patients with earlier access to LBS-008.

“We are delighted that LBS-008 has received FDA Fast Track Designation. STGD1 is a terrible retinal disease with the potential to severely affect the vision of afflicted patients and there are currently no approved treatments,” said Dr Tom Lin, the Belite Bio Chairman and CEO.

“At present, we are conducting a Phase 3 clinical trial in order to bring to market a treatment that will halt or slow the progression of STGD1. Additionally, we are evaluating our plan to launch a Phase 2/3 trial in Dry AMD in 2022. Dry AMD is a disease which shares a similar underlying pathophysiology with STGD1 and is a leading cause of central vision loss in people over 50.”

There are currently no approved treatments for Stargardt disease.

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