- Aldeyra Therapeutics Inc ALDX announced topline results from a 12-month clinical trial of reproxalap, an investigational new drug, in dry eye disease patients.
- The primary endpoints of treatment-related serious adverse events in ocular safety were not observed in any patient.
- Ocular safety events were similar across reproxalap and vehicle treatment groups.
- Related: Aldeyra's Reproxalap Hits Primary Goals In Dry Eye Disease Chamber Crossover Trial.
- In a post-hoc analysis, reproxalap was statistically superior to vehicle in improvement from baseline in distance visual acuity, potentially representing the first demonstration of improvement in distance visual acuity with a topically administered therapy.
- The 12-month safety clinical trial population comprised 447 dry eye disease patients.
- Visual acuity improved over 12 months in both treatment groups, and improvement in patients treated with reproxalap was statistically superior (P=0.018) to those treated with vehicle.
- In the reproxalap treatment group, logMAR improved by approximately 37%, from 0.13 to 0.08.
- Price Action: ALDX shares are down 2.70% at $6.93 on the last check Tuesday.
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