NDA Resubmitted for Dry Eye Treatment Reproxalap

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Biotechnology company Aldeyra Therapeutics announced today the resubmission of a new drug application (NDA) to the FDA for the potential topical dry eye and allergic conjunctivitis treatment reproxalap, according to a news release.

The resubmission includes positive results from a recently completed phase 3 clinical trial and a draft label reflecting effectiveness in three chamber trials and one field trial. Reproxalap has been tested on more than 2,500 patients with no observed safety concerns other than mild site installation irritation.

Aldeyra’s original NDA submission in November 2022 was rejected by the FDA the following November in a complete response letter that cited a lack of supporting evidence for reproxalap’s efficacy and requested an additional study with positive results.

In August 2024, reproxalap achieved the primary endpoint in a phase 3 clinical trial, the first positive phase 3 clinical dry eye with a symptom as a primary endpoint, to Aldeyra’s knowledge. During the trial, 132 participants were treated with reproxalap or vehicle after exposure to a dry eye chamber, which controls temperature, humidity and air flow. Dry eye chambers have been used in studies to simulate the effect of airplane cabins on contact lens wearers. Primary endpoint was ocular discomfort from 80 to 100 minutes in the dry eye chamber.

“If approved, reproxalap would have the potential to be the first dry eye disease therapy for chronic use with pivotal data demonstrating acute activity in reducing dry eye symptoms and ocular redness, two characteristics of dry eye disease of primary importance to patients,” Todd C. Brady, M.D., Ph.D., Aldeyra’s president and CEO said in the news release.

About 39 million people in the United States suffer from dry eye disease, characterized by insufficient eye moisture and lubrication. Symptoms include inflammation, pain, a gritty sensation in the eyes and a diminished quality of life. In severe cases it can lead to permanent vision impairment.

Reproxalap is a first-in-class small-molecule modulator of RASP (reactive aldehyde species), which causes inflammation by damaging the tear lipids that maintain the eye moisture barrier. When the barrier is damaged, the eyes can become dry, leading to dry eye disease.

The Prescription Drug User Fee Act guidelines for NDA resubmissions say that the FDA must acknowledge the resubmission with 30 days of submission. The FDA must then complete the review within six months.

Aldeyra has entered a co-exclusive license agreement with pharmaceutical company AbbVie to develop, manufacture and commercialize reproxalap inside and outside the United States.