HQ Team
April 3, 2025: The US Food and Drug Administration has rejected the biotechnology company Aldeyra Therapeutics Inc’s investigational drug for treating dry eyes, over concerns with the data from the trial.
The FDA has told the company to resubmit the New Drug Application by issuing a Complete Response Letter which states that the application “failed to demonstrate efficacy in adequate and well-controlled studies in treating ocular symptoms associated with dry eyes,” according to a company statement.
The US drug regulator also needed “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of a dry eye.”
The investigational drug, Reproxalap, is in development for the treatment of dry eye disease and allergic conjunctivitis, two of the largest markets in ophthalmology. The FDA had rejected the drug earlier in 2023.
FDA guidance
After the initial rejection, Aldeyra initiated three clinical trials assessing dry eye disease symptoms. In August 2024, Aldeyra announced the achievement of the primary endpoint in one of the clinical trials of Reproxalap, and the NDA was resubmitted in October 2024.
It plans to resubmit the application by the middle of this year after discussions with the FDA. According to the draft FDA dry eye disease guidance, efficacy in the disease may be demonstrated with two symptom trials and two sign trials. This is needed to be considered for regulatory approval in the US.
“Pending positive results from the ongoing clinical trials and discussions with the FDA, we look forward to a potential NDA resubmission mid-year 2025,” said Todd C. Brady, MD., PhD, President and Chief Executive Officer of Aldeyra Therapeutics.
Burning, irritation
“Reproxalap remains the only late-stage topical ocular therapy suitable for chronic administration to have potentially demonstrated an acute reduction in ocular redness, as well as a reduction in ocular discomfort, highlighting rapid and broad activity for both the signs and symptoms of dry eye disease.”
If the eyes do not produce enough tears, it is called dry eye. Dry eye is also when eyes do not make the right type of tears or when tears dry out too quickly. It can cause problems with one’s vision. The World Health Organization estimates that dry eye disease prevalence ranges from 5% to 50% globally, with higher rates in Asia.
The disease can cause a wide range of ocular symptoms, including redness, dryness, discomfort, itching, stinging, burning, irritation, pain, photophobia, and a foreign body sensation.
