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Aldeyra's Dry Eye Drug Gets Delayed FDA Decision After Last-Minute Clinical Data Request

MarketDash Editorial Team
9 hours ago
The FDA pushed Aldeyra Therapeutics' reproxalap decision to March 2026 after requesting a clinical study report from a field trial that didn't meet its primary endpoint, though the agency hasn't flagged other review issues.

Aldeyra Therapeutics Inc. (ALDX) just learned that waiting for FDA approval requires a bit more patience than expected. The agency announced Monday it's pushing back its decision date for reproxalap, the company's dry eye disease treatment, to March 16, 2026.

The three-month delay stems from what the FDA calls a "major amendment" to the New Drug Application, though the circumstances are somewhat unusual.

How We Got Here

Aldeyra submitted its reproxalap NDA back in June, and by July 16, the FDA had accepted it for review as a "complete class 2 response" with a target decision date of December 16. Everything seemed on track for a year-end verdict.

Then last Friday, the FDA held a meeting with Aldeyra and made an unexpected request: submit the full Clinical Study Report from the company's dry eye disease field trial. The company had announced topline results from that trial back in May 2025.

Here's the wrinkle: the field trial showed that reproxalap had activity relative to the placebo vehicle, but it didn't meet its primary endpoint of improving dry eye symptoms compared to the control. Aldeyra had discussed this trial with the FDA before submitting the NDA in June, and the agency had already reviewed safety data from the study back in August.

The Amendment That Changed Everything

The Clinical Study Report had already been sitting in the Investigational New Drug file for reproxalap. Aldeyra submitted it to the NDA on the same day as the December 12 meeting, but the FDA classified it as a major amendment, which triggers an extension of the review timeline under regulatory procedures.

The somewhat reassuring news? At the meeting, the FDA made no other requests and didn't flag any specific problems with the NDA review. The agency had even shared a draft prospective label with Aldeyra in early December, and the company has already submitted its response.

What Happens Next

The FDA told Aldeyra that if no major deficiencies surface during the extended review period, it plans to communicate proposed labeling requests and any anticipated postmarketing requirements by February 16, 2026. That would be about a month before the new March decision deadline.

The market wasn't thrilled with the delay. Aldeyra shares tumbled 12.1% on Monday to close at $3.99, then slipped another 1.5% in premarket trading Tuesday to $3.93.

Back to News

Aldeyra's Dry Eye Drug Gets Delayed FDA Decision After Last-Minute Clinical Data Request

MarketDash Editorial Team
9 hours ago
The FDA pushed Aldeyra Therapeutics' reproxalap decision to March 2026 after requesting a clinical study report from a field trial that didn't meet its primary endpoint, though the agency hasn't flagged other review issues.

Aldeyra Therapeutics Inc. (ALDX) just learned that waiting for FDA approval requires a bit more patience than expected. The agency announced Monday it's pushing back its decision date for reproxalap, the company's dry eye disease treatment, to March 16, 2026.

The three-month delay stems from what the FDA calls a "major amendment" to the New Drug Application, though the circumstances are somewhat unusual.

How We Got Here

Aldeyra submitted its reproxalap NDA back in June, and by July 16, the FDA had accepted it for review as a "complete class 2 response" with a target decision date of December 16. Everything seemed on track for a year-end verdict.

Then last Friday, the FDA held a meeting with Aldeyra and made an unexpected request: submit the full Clinical Study Report from the company's dry eye disease field trial. The company had announced topline results from that trial back in May 2025.

Here's the wrinkle: the field trial showed that reproxalap had activity relative to the placebo vehicle, but it didn't meet its primary endpoint of improving dry eye symptoms compared to the control. Aldeyra had discussed this trial with the FDA before submitting the NDA in June, and the agency had already reviewed safety data from the study back in August.

The Amendment That Changed Everything

The Clinical Study Report had already been sitting in the Investigational New Drug file for reproxalap. Aldeyra submitted it to the NDA on the same day as the December 12 meeting, but the FDA classified it as a major amendment, which triggers an extension of the review timeline under regulatory procedures.

The somewhat reassuring news? At the meeting, the FDA made no other requests and didn't flag any specific problems with the NDA review. The agency had even shared a draft prospective label with Aldeyra in early December, and the company has already submitted its response.

What Happens Next

The FDA told Aldeyra that if no major deficiencies surface during the extended review period, it plans to communicate proposed labeling requests and any anticipated postmarketing requirements by February 16, 2026. That would be about a month before the new March decision deadline.

The market wasn't thrilled with the delay. Aldeyra shares tumbled 12.1% on Monday to close at $3.99, then slipped another 1.5% in premarket trading Tuesday to $3.93.