Aldeyra's New Eye Drug Shows Positive Results In FDA-Approved Study, Stock Jumps Over 30%

Aldeyra Therapeutics Inc.’s ALDX Phase 3 dry eye chamber clinical trial of 0.25% reproxalap ophthalmic solution achieves the primary endpoint.

Reproxalap, an investigational new drug candidate for dry eye disease, was statistically superior to the vehicle for the prespecified primary endpoint of ocular discomfort (P=0.004), an FDA-accepted symptom of dry eye disease.

The company enrolled the first patient in the trial in May 2024 and concluded the study in June.

In the Phase 3 clinical trial, patients were administered vehicle (the drug product without the active ingredient) before and during exposure to a dry eye chamber in a manner that Aldeyra believes is consistent with the FDA’s dry eye disease draft guidance.

Qualifying patients were subsequently randomized to receive either reproxalap or vehicle before and during exposure to an additional dry eye chamber.

Of the 132 patients randomized, 66 patients received reproxalap, and 66 received vehicle.

The primary endpoint was ocular discomfort, an FDA-accepted symptom of dry eye disease, from 80 to 100 minutes in the chamber.

The dry eye chamber clinical trial was designed to satisfy the FDA’s New Drug Application resubmission requirement, identified in the previously received complete response letter, of “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye.”

Aldeyra says that in patients with dry eye disease, reproxalap is the first investigational drug with pivotal data supporting acute and chronic activity in reducing symptoms and the first investigational drug for chronic administration with pivotal data supporting acute activity in reducing ocular redness.

The potential NDA resubmission is anticipated in 2024. Based on FDA guidance, the resubmission NDA review period is expected to be six months.

No safety signals were observed in the clinical trial, and reproxalap was well tolerated.

No treatment-related discontinuations were reported. Reproxalap has now been studied in over 2,500 patients.

Price Action: ALDX stock is up 34.8% at $4.40 at last check Thursday.

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