Aldeyra Therapeutics presented the results of a randomized, double-blind clinical trial of phase 2a on patients with ocular dryness treated with reproxalap at the ARVO annual meeting. The main objective of the experimentation, that is to select a formulation for the Phase 2b clinical trial, was reached with the progress of reproxalap at 0.1%. Compared to baseline, patients with dry eye disease treated with 0.1% reproxalap showed a statistically significant improvement in tear volume (Schirmer test), as well as a statistically and clinically significant improvement in the overall 4-symptom score and in the ocular disability score. Fifty-one subjects with active dry eye disease were randomized to receive ocular reproxalap for topical use at 0.1%, reproxalap at 0.5% or reproxalap formulated with 0.5% lipids four times a day. The results indicated statistically significant changes in the SANDE score (Assessment symptom in the case of dry eye), the ocular discomfort score, the overall score of 4 symptoms, the tear volume (Schirmer test), the osmolarity and the coloration of the cornea (Lissamine Green). A modest dose-dependent response was observed and improvement in symptoms was observed within one week of therapy. In January 2018 Aldeyra announced the start of a Phase 2b clinical trial that will recruit 300 patients with active disease, randomized to receive 0.1% or 0.25% reproxalap. The results of the study should be announced in the second half of 2018.

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