Aldeyra Highlights 12-Month Safety Data Of Reproxalap In Dry Eye Disease Patients
Aldeyra Therapeutics Inc (NASDAQ: 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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