Aldeyra Therapeutics Presents Dry Eye Disease Phase 2a Clinical Trial Results at ARVO

Aldeyra Therapeutics presented the results of a randomized, double-masked, parallel-group phase 2a dry eye disease clinical trial of topical ocular reproxalap at the Association for Research in Vision and Ophthalmology (ARVO) 2018 Annual Meeting. The primary objective of the trial, to select a formulation for phase 2b clinical testing, was achieved with the advancement of 0.1% reproxalap.

Relative to baseline, dry eye disease patients treated with 0.1% reproxalap demonstrated statistically significant improvement from baseline in tear volume (Schirmer test) as well as statistically and clinically significant improvement in the Overall 4-Symptom Score and the Ocular Discomfort Score. Tear levels of pro-inflammatory reactive aldehyde species (RASP), which are sequestered by reproxalap, were significantly decreased following treatment. Aldeyra released topline results from the trial in September 2017.  Dr. David Clark, Chief Medical Officer at Aldeyra, gave the presentation, which is available on the investor relations page of the Aldeyra Therapeutics corporate website at ir.aldeyra.com.

“Reproxalap could represent an important treatment for many patients that suffer from dry eye disease,” Gary Foulks, MD, FACS, Professor Emeritus, Department of Ophthalmology & Visual Sciences at the University of Louisville, said in a company news release. “The activity demonstrated within one week of therapy in the phase 2a clinical trial presented today suggests that reproxalap could have significant potential for the treatment of dry eye disease.”

Fifty-one subjects with active dry eye disease were randomized equally to receive either topical ocular 0.1% reproxalap, 0.5% reproxalap, or 0.5% lipid formulation reproxalap four times daily. Results pooled from all drug groups indicated statistically significant changes in the Symptom Assessment in Dry Eye (SANDE) score, the ocular discomfort score, the overall 4-symptom score, tear volume (Schirmer test), osmolarity, and corneal staining (Lissamine Green). A modest dose response was observed, and improvement in symptoms was noted by one week of therapy. Improvement in corneal staining and osmolarity correlated with reduction in tear RASP levels. The tolerability of topical ocular 0.1% reproxalap was consistent with standard of care in dry eye disease patients, and there were no observed safety concerns, consistent with previous Phase 1 and Phase 2 clinical trials.

In January 2018, Aldeyra announced the initiation of a phase 2b clinical trial of topical ocular reproxalap in dry eye disease. The phase 2b trial is expected to enroll 300 patients with active disease, randomized equally to receive either 0.1% reproxalap, 0.25% reproxalap, or vehicle for 3 months. Results of the trial are expected to be announced in the second half of 2018.