Alcon Reports the US FDA’s Approval of Tryptyr to Treat Dry Eye Disease
Shots:
- The US FDA has approved Tryptyr (0.003% acoltremon ophthalmic solution; AR-15512) to treat signs & symptoms of dry eye disease (DED); US launch expected in Q3’25
- Approval was backed by 2 P-III (COMET-2 & COMET-3) trials assessing Tryptyr vs vehicle in >930 pts with DED, where Tryptyr showed ≥10mm natural tear production increase by Day 14 (42.6% vs 8.2% and 53.2% vs 14.4%), with effects seen as early as Day 1 & sustained through Day 90
- In preclinical studies, acoltremon was shown to activate TRPM8 thermoreceptors, triggering trigeminal nerve pathways associated with increased basal tear production, though Tryptyr’s exact MoA in DED remains unclear
Ref: Businesswire| Image: Alcon| Press Release
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