Aldeyra's Dry Eye Drug Faces Second FDA Rejection, Company Remains Optimistic

Aldeyra Therapeutics has encountered a significant setback in its pursuit of approval for its dry eye disease treatment, reproxalap. The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) rejecting the company's second application for the drug, citing the need for additional efficacy data.

FDA Rejection and Requested Data

The FDA's decision, announced on April 4, 2025, stems from the agency's assessment that Aldeyra's submission "failed to demonstrate efficacy in adequate and well-controlled studies in treating ocular symptoms associated with dry eyes." As a result, the regulator has requested at least one additional well-controlled study to establish the drug's positive effect on ocular symptoms of dry eye disease.

This marks the second rejection for reproxalap, following an initial CRL in November 2023. The FDA did not raise any safety or manufacturing concerns in its latest communication, focusing solely on efficacy issues.

Aldeyra's Response and Ongoing Trials

Despite the setback, Aldeyra CEO Todd Brady remains optimistic, citing "pending positive results from ongoing clinical trials." The company is currently conducting three additional studies of reproxalap:

1. Two dry eye chamber trials, each using different chambers
2. A six-week field trial

Aldeyra expects to release topline results from the field trial and one of the chamber trials in the second quarter of 2025. The company plans to meet with the FDA within 30 days to discuss the rejection and potentially use these new data to support a resubmission of the drug application by mid-2025.

Financial and Market Impact

The news of the FDA rejection has had a significant impact on Aldeyra's stock price, with shares falling 73% since the start of the week. The company's stock, which was trading at $6.80 per share earlier in the week, dropped to $1.83 by Friday.

Aldeyra reported $101 million in cash, cash equivalents, and marketable securities at the end of 2024. The company estimates that its ongoing reproxalap trials will cost approximately $6 million this year.

In a strategic move, Aldeyra signed a deal with AbbVie in late October 2023, granting the latter an option to co-license the development, manufacturing, and commercialization of reproxalap in the United States. The agreement included an immediate $1 million payment, with an additional $100 million due if AbbVie chooses to exercise the option, which it has not done to date.