Aldeyra climbs after late-stage success for dry eye disease therapy

Shares of Aldeyra Therapeutics (NASDAQ:ALDX) surged ~26% on Thursday after the company said its lead asset, reproxalap ophthalmic solution, reached the main goal in a Phase 3 trial for patients with dry eye disease.

Aldeyra (ALDX) ran the trial after the FDA rejected its marketing application for reproxalap in November, citing the need for “at least one additional adequate and well-controlled study” to demonstrate its clinical benefits against dry eye disease symptoms.

The company said reproxalap reached the primary endpoint for ocular discomfort, the FDA-accepted symptom of dry eye disease, indicating statistical superiority against a comparator. There were no new safety signals, and the experimental therapy was well tolerated. ALDX added.

The company said it intends to resubmit its new drug application for reproxalap in 2024 and expects the agency’s review period to last six months.

In November, pharma giant AbbVie (ABBV) inked an option agreement to obtain commercial rights for reproxalap.