Belite Bio Starts Rolling Submission of New Drug Application for Eye Treatment

Dow Jones04-22

By Christopher Kuo

Belite Bio started rolling submission of a New Drug Application to the Food and Drug Administration for its treatment of a rare retinal disorder.

The company on Tuesday said it expects to complete the submission in the second quarter. The NDA is for the company's drug tinlarebant, which is designed to treat Stargardt disease type 1, an inherited retinal disorder caused by genetic mutations that often results in legal blindness.

The company has completed a Phase 3 trial in adolescent STGD1 subjects. Tinlarebant was previously granted Breakthrough Therapy Designation by the FDA, the company said.

Write to Christopher Kuo at chris.kuo@wsj.com

(END) Dow Jones Newswires

April 21, 2026 17:00 ET (21:00 GMT)

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