Belite Bio reported topline results from the global Phase 3 DRAGON trial showing that tinlarebant met the study’s primary endpoint in adolescents with Stargardt disease type 1 (STGD1). The company said the data represent the first successful pivotal trial in STGD1 and positions tinlarebant to become the first approved therapy for the inherited macular degeneration that causes progressive vision loss. Belite’s announcements indicate plans to pursue regulatory filings — including in the U.S. — next year. The DRAGON trial focused on adolescents, a population where disease progression often starts early; achieving a primary endpoint in this group strengthens the company’s filing strategy. Belite and related media coverage emphasize the unmet medical need and potential commercial implications of an approved treatment for a formerly untreatable rare retinal disorder. The results also underscore investor and market interest in rare ophthalmology programs with clear endpoints. Sponsors and regulators will now scrutinize the full dataset and safety profile ahead of submission timelines and potential approval discussions.