No Solace For Aldeyra As Late-Stage Study Of Lead Drug In Anterior Uveitis Fails

Shares of Aldeyra Therapeutics Inc ALDX, a thinly traded micro-cap biotech, plummeted Tuesday morning.

What Happened

Aldeyra, which focuses on therapies for immune-mediated diseases, reported its Phase 3 trial dubbed SOLACE that evaluated its reproxalap, code-named ADX-102 (a topical ophthalmic solution) in non-infectious anterior uveitis did not meet both the primary and secondary endpoints.

Anterior uveitis is an inflammation of the middle layer of the eye.

The company clarified the failure of the study was due to high rates of disease resolution in vehicle-treated patients, but said the activity of reproxalap was consistently greater than that of vehicle.

Reproxalap is also being evaluated in separate late-stage studies in allergic conjunctivitis as well as dry eye disease. In a Phase 3 study for the former indication and in a Phase 2a study for the latter indication, the pipeline asset showed highly statistically significant immune-modulating activity.

What's Next

Aldeyra said it looks forward to aggressively prioritize advancement of high-valve ocular programs in dry eye disease, allergic conjunctivitis and proliferative vitreoretinopathy.

Aldeyra shares traded lower by 25.9% to $5.25 in Tuesday's pre-market session.

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