Positive topline results reported in run-in cohort of reproxalap phase 3 trial
Reproxalap demonstrated statistically significant improvements in dry eye symptoms, redness and Schirmer’s test results compared with vehicle in a run-in cohort of the phase 3 TRANQUILITY clinical trial, Aldeyra Therapeutics announced.
The 23 participants in the double-masked, single-center, parallel-group run-in cohort were randomly assigned to receive either 0.25% reproxalap or vehicle ophthalmic solution, according to a press release. Doses were administered four times the day before and two times the day of a 90-minute exposure to a dry eye chamber with low humidity, high airflow and forced visual tasking.
Reproxalap was statistically superior to vehicle for improving visual analog scale (VAS) ocular dryness score (P = .001) and ocular discomfort score (P < .0001) and demonstrated statistically significant improvement in ocular redness (P = .03) vs. vehicle. Reproxalap also showed statistically superior improvement in VAS dryness score (P = .003), ocular discomfort 4-symptom questionnaire (OD4SQ) dryness score (P = .006), OD4SQ grittiness score (P = .006) and OD4SQ discomfort score (P = .003) the day before the air chamber exposure. In addition, Schirmer’s test results were “directionally in favor” of reproxalap.
“The activity of reproxalap in reducing ocular redness, initially demonstrated in the allergen chamber phase 2 clinical trial, was also observed in the dry eye chamber run-in results of TRANQUILITY, and we look forward to initiating enrollment of the main cohort,” Todd C. Brady, MD, PhD, Aldeyra president and CEO, said in the release.
The company anticipates enrollment for the main cohort to begin in February after tear RASP analysis from the run-in cohort and endpoint confirmations are complete. TRANQUILITY results are expected later this year, with the initiation of a second phase 3 clinical trial, TRANQUILITY-2, later this quarter.