Reproxalap meets primary endpoint in phase 3 dry eye trial
Click Here to Manage Email Alerts
Reproxalap, under investigation for the treatment of dry eye disease, met the primary endpoint in the phase 3 TRANQUILITY-2 trial, Aldeyra Therapeutics announced in a press release.
Reproxalap, a small-molecule modulator of reactive aldehyde species, was superior to vehicle in two measures, Schirmer’s test change from baseline (P = .001) and 10 mm or greater Schirmer test responder proportions (P < .0001).
“The positive results of TRANQUILITY-2 are expected to complete the most comprehensive dry eye disease NDA submission to date,” Todd C. Brady, MD, PhD, Aldeyra president and CEO, said in the release.
The company plans to hold meetings with the FDA in the third quarter before potentially submitting a new drug application with ocular dryness symptom score, ocular redness, Schirmer test, and 10 mm or greater Schirmer test responder analysis. The submission will be pending enrollment in an ongoing 12-month safety trial and results from a dry eye chamber crossover trial.
Read more about
Click Here to Manage Email Alerts