Novel reactive aldehyde species inhibitor shows potential in dry eye disease
A novel reactive aldehyde species (RASP) inhibitor demonstrated statistically significant improvement over vehicle in signs of dry eye disease, according to results from a phase 2b trial.
In this randomized, double-masked, vehicle-controlled study, 300 patients with dry eye disease were randomly assigned to receive 0.1% topical ocular reproxalap, 0.25% topical ocular reproxalap, or vehicle, 4 times daily for 12 weeks. The signs and symptoms of dry eye disease were assessed at baseline and at weeks 2, 4, 8, and 12.
A dose-response was observed. The largest symptomatic improvement was seen in ocular dryness and the largest objective sign improvement was observed in nasal region fluorescein staining in patients treated with topical ocular reproxalap relative to vehicle over 12 weeks. Compared to the vehicle group, more patients receiving 0.25% reproxalap reported dryness scores of 0. In patients with baseline scores ≥ median values, improvements in combined dry eye symptoms were seen by week 2.
No significant changes in safety measures were observed.
Clark D, Tauber J, Sheppard J, et al. Early onset and broad activity of reproxalap in a randomized, double-masked, vehicle-controlled phase 2b Trial in dry eye disease. Am J Ophthalmol. 2021;DOI:https://doi.org/10.1016/j.ajo.2021.01.011