Aldeyra Therapeutics plans to make another run at FDA approval for its dry eye disease drug after the agency handed down a complete response letter last year.
The company said Thursday that a Phase 3 trial for reproxalap hit the primary endpoint. The drug showed statistical superiority to the so-called vehicle — the drug without the active ingredient — in ocular discomfort (a symptom of the disease), earning a p=0.004. Patients were randomized to get reproxalap or the vehicle before and during exposure to a dry eye chamber.
Aldeyra’s stock $ALDX was up about 26% on Thursday afternoon following the announcement.
It expects to resubmit its NDA this year.
According to Aldeyra, the trial was designed to satisfy the FDA’s resubmission requirement from the CRL of at least one more trial to show a positive effect on ocular symptoms of dry eye disease. The company announced in March that it would run another trial as part of its resubmission plans.
The company expects to resubmit its NDA later this year.
“To our knowledge, the results announced today represent the first positive Phase 3 clinical trial in a dry eye chamber with a symptom as a primary endpoint, and we believe that the results are supportive of the potential rapid clinical effect of reproxalap on reducing the ocular discomfort associated with dry eye disease,” Aldeyra president and CEO Todd Brady said in a statement.
There were no safety signals in this study, and the company said the drug was well tolerated. The most commonly reported adverse event was mild and transient, and there were no treatment-related discontinuations.
Reproxalap’s development has hit several roadblocks. It failed to meet the primary endpoint in a Phase 3 study assessing eye redness in December 2021. It subsequently passed a Phase 3 study with a new primary endpoint measuring tear production, and then it passed a crossover study, meeting both primary endpoints of redness and tear production.
Aldeyra inked a licensing deal with AbbVie late last year for reproxalap, receiving $1 million. However, it could get up to $99 million and milestone payments if the drug is approved.