BLTE - Belite seeks FDA nod to proceed with phase 3 trial of genetic eye disease treatment
- Belite Bio ( NASDAQ: BLTE ) on Tuesday said it had submitted an investigational new drug application to the U.S. FDA to proceed with its phase 3 trial of its oral tablet LBS-008 for the treatment of Stargardt disease (STGD1).
- STGD1 is a rare genetic eye disease that is characterized by fatty material build up on the macula.
- Belite Bio ( BLTE ) said it is currently conducting a 2-year phase 2 trial and a 2-year phase 3 trial of LBS-008 in adolescent STGD1 subjects.
- The company said its phase 3 trial, called DRAGON, had already been approved for enrollment in the UK, Switzerland, Hong Kong, Taiwan and Australia.
- U.S.-listed shares of BLTE earlier closed +5.3% at $43.70.
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Belite seeks FDA nod to proceed with phase 3 trial of genetic eye disease treatment