Belite Bio (BLTE) said Monday that a phase 3 trial of Tinlarebant to treat Stargardt disease type 1 met its primary efficacy endpoint.

Results showed a "statistically significant" reduction in lesion growth rate of 35.7%, compared with placebo as measured by retinal imaging, the company said. The trial saw a statistically significant treatment effect in the fellow eye for the primary endpoint with 33.6% lesion growth reduction.

Tinlarebant was "well tolerated," with only four treatment-related discontinuations, Belite Bio said.

The company intends to discuss potential next steps with regulatory authorities and to submit new drug applications for Tinlarebant in H1 2026.

Stargardt disease type 1 is an eye disease that results in progressive vision loss.

Belite Bio shares were up 20% in recent premarket activity.