The FDA granted priority review designation to a new drug application for tinlarebant, a potential treatment for Stargardt disease type 1, according to a press release from Belite Bio.
The oral therapy, which is designed to reduce the accumulation of vitamin A-based toxins that contribute to the progression of retinal diseases, was assigned a Prescription Drug User Fee Act date of Feb. 12, 2027. The designation was supported by results from the phase 3 DRAGON trial, which reported a 35.7% reduction in the growth rate of atrophic retinal lesions with tinlarebant vs. placebo, as Healio