Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases, today announced the FDA submission of a Phase 3 clinical study protocol to evaluate efficacy and safety of Tinlarebant (a/k/a LBS-008) in patients with geographic atrophy (GA) associated with Dry AMD.

“Dry AMD is a chronic degenerative disease of the retina that leads to blindness in the elderly. We believe that Tinlarebant, being an oral once-a-day tablet, would be a non-invasive, more convenient, and well-tolerated long-term treatment for Dry AMD.” said Dr. Tom Lin, CEO of Belite Bio.

Phase 3 Advanced Dry AMD Study Outline

• 2-year prospective, randomized (2:1, active:placebo), double-masked, placebo-controlled study designed to assess the efficacy and safety of daily oral Tinlarebant.
• Enrollment of approximately 430 GA patients across multiple centers globally is expected to begin in the first half 2023
• The primary endpoint will be the change in GA lesion size from baseline to month 24, compared to placebo.
• An interim analysis of efficacy and safety is expected to be conducted at the mid-point of the study.

For full release please visit investors.belitebio.com