US-based Aldeyra Therapeutics announced it’s 0.25% reproxalap ophthalmic solution met its primary endpoint in a phase 2 clinical trial in dry eye disease (DED) patients.
Of the 158 patients enrolled in the randomised, double-masked, vehicle-controlled trial, 80 received the 0.25% reproxalap ophthalmic solution, while 78 received the vehicle solution alone. Four doses were given one day prior to and two doses during exposure to a 90-minute dry-eye chamber with minimal humidity, high airflow and forced visual tasking. Ocular redness scores in the reproxalap group were observed to be statistically lower than those of vehicle (p = 0.016), while Schirmer’s test scores after the first dose were in favour of reproxalap over vehicle and approached statistical significance (p = 0.068). Mean ocular dryness and discomfort scores were lower in reproxalap-treated subjects but were not statistically significant.
Reproxalap is a novel small-molecule immune-modulating covalent inhibitor of reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory disease. Two phase 3 trials of 300 patients each are underway.