According to a recent press release, Aldeyra Therapeutics has resubmitted a New Drug Application to the U.S. Food and Drug Administration for reproxalap, a topical ocular therapy for dry eye disease.
The resubmission follows positive results from a Phase 3 clinical trial requested by the FDA after a previously submitted New Drug Application (NDA), and includes data from acute and chronic symptom reduction trials.
Reproxalap works by inhibiting reactive aldehyde species, which are believed to play a key role in the inflammation associated with dry eye disease. The medication demonstrated significant reductions in ocular discomfort and ocular redness in both acute and chronic trials. The safety data included in the resubmission showed reproxalap was well tolerated with no serious adverse events linked to the therapy.
"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,” said Aldeyra President and CEO Todd C. Brady, MD, PhD in the press release.
Update, November 18, 2024: The FDA has accepted the resubmitted NDA for reproxalap. According to a new press release, Aldeyra has entered into an option agreement with AbbVie to develop, manufacture, and commercialize the drug if it is approved.
