Bausch + Lomb clarifies clinical path for oral dry AMD drug BL1243 after FDA meeting
Bausch + Lomb announced that the U.S. Food and Drug Administration gave constructive feedback on the design of the initial study for BL1243 (tonabersat), an oral therapy for dry age‑related macular degeneration. The agency’s support clears the way for a Phase 2 safety and pharmacokinetic trial slated to begin in 2027. Company executives said the oral route could enable earlier treatment of patients before irreversible retinal damage.
Why it matters
The company expects the 2027 trial start to provide data that could advance BL1243 toward later‑stage development, potentially adding a new revenue stream if successful. The FDA endorsement reduces regulatory uncertainty, which may improve the valuation outlook for the stock.
Key facts
- 1The FDA was supportive, in principle, of the proposed initial study design for BL1243. marketscreener.com
- 2Bausch + Lomb plans to initiate the dry AMD clinical program in 2027. marketscreener.com
- 3BL1243 (tonabersat) has previously been studied in approximately 2,100 people, including a 63‑participant diabetic macular edema trial. marketscreener.com
- 4Bausch + Lomb’s current Price‑to‑Sales ratio is 1.18x. gurufocus.com
- 5The company’s GF Score™ is 60 out of 100. gurufocus.com
- 6Revenue for the most recent period was US$5,324.0 million. simplywall.st
Summary written by AlphAI from 7 of 7 sources. Not investment advice. Figures are as stated by the linked sources.