Belite Bio Eyes Priority FDA Review as Tinlarebant Targets Stargardt Disease

Belite Bio says Tinlarebant has completed its Phase 3 DRAGON trial for Stargardt disease, and Chief Medical Officer Hendrik Scholl said the company believes it is reasonable to expect priority FDA review after its rolling NDA filing, citing breakthrough therapy designation and ongoing discussions with regulators. Tinlarebant is designed to reduce toxic vitamin A-related buildup in the retina by targeting RBP4, with Belite saying a 5-mg daily dose cuts eye-available retinol by about 80%. The drug is also being studied for geographic atrophy, where the biology and imaging features can resemble Stargardt disease. The company’s safety discussion emphasized mostly manageable visual adaptation effects, including xanthopsia and delayed dark adaptation, with no serious ocular treatment-emergent adverse events reported. Belite is also running DRAGON II to support potential approval in Japan, where Tinlarebant has received Sakigake designation. MarketBeat previews top five stocks to own in August. 3 Lesser-Known Healthcare Names With Major Upside in Store Belite Bio NASDAQ: BLTE Chief Medical Officer Hendrik Scholl said the company is advancing its lead compound, Tinlarebant, as a potential treatment for Stargardt disease and geographic atrophy secondary to age-related macular degeneration, two severe retinal diseases with overlapping features. Speaking during a company news event, Scholl described Belite Bio as a biotech company focused on “unmet medical need in severe retinal diseases.” He said Tinlarebant has completed a Phase 3 clinical trial called DRAGON in Stargardt disease, an inherited retinal disorder that he described as “the leading cause of blindness in adolescents and juveniles.” Get Belite Bio alerts: Sign Up Tinlarebant’s mechanism targets vitamin A availability in the ey...