Aldeyra Therapeutics, Inc. announced the FDA has extended the Prescription Drug User Fee Act (PDUFA) target action date for the new drug application (NDA) of its dry eye disease (DED)-indicated therapeutic: reproxalap.
An extension is better than another rejection … let’s get a reproxalap refresh.
We’ll be brief on Aldeyra’s flagship candidate, as it’s been covered extensively over the last 2+ years.
What it is: A small-molecule modulator of the molecule class reactive aldehyde species (RASP), which are notorious for being elevated in ocular and systemic inflammatory disease.
- Details on the ocular impact of RASP can be found here.
- And see here for a rundown on Aldeyra’s RASP Modulator Platform.
As for how reproxalap works: Formulated as a topically-administered eye drop, its mechanism of action includes a near-instant (within minutes) effect in reducing DED symptoms.
- Notably: This reduction can last up to 12 weeks.
That’s a big claim. What clinical data backs this up?
As we previously reported, this impact was observed across five clinical trials and nearly 3K patients.
And our own coverage has included:
- Phase 3 data from a dry eye chamber trial
- Positive findings from a 12-month safety trial
Duly noted. So, what’s led up to the FDA’s most recent reproxalap update?
Quite a few developments, to say the least. And it all circles back to its NDA.
Most prominently: The federal agency accepted Aldeyra’s NDA resubmission in July 2025 after previously rejecting (twice over) its prior application attempts.
- Check out this timeline of events we put together last year.
And what was new in this NDA submission?
The addition of clinical data from another phase 3 dry eye chamber trial (different from the one we referenced earlier) that was conducted for the sole purpose of being included in the new NDA.
In addition to meeting its primary endpoint of ocular discomfort, the study also demonstrated:
- Reproxalap’s statistically superior efficacy (versus vehicle) in reducing ocular discomfort
- There was no major difference in baseline scores between treatment arms
Any other data?
One more! When reporting the phase 3 data in May 2025, Aldeyra also shared that results from a separate, recently completed DED field trial were “numerically supportive of reproxalap and consistent with prior field trials.”
- Further: Its data would also be included in the NDA resubmission as “supportive” of reproxalap’s activity relative to vehicle.
But just one notable drawback: It failed to reach statistical significance.
Noted. So what was the original PDUFA date?
Dec. 16, 2025.
And now?
The FDA has updated (extended) that target action date to March 16, 2026.
Why the need for an extension?
This decision was made following a Dec. 12 meeting between Aldeyra and the FDA, during which the agency reportedly requested the company submit the clinical study report (CSR) from that aforementioned dry eye field trial.
- To refresh: CSRs are standardized full reports that summarize a clinical study's data and outcomes, and are typically submitted as part of a drug’s approval process.
And in reproxalap’s case?
Stay with us as we explain the situation …
- To start: The field trial’s CSR had previously been submitted to the eye drop’s investigational new drug (IND) file (which the FDA reviewed under the IND).
- As for its inclusion in the updated NDA submission: This only extended to the field trial’s safety data, which Aldeyra reportedly submitted in late August following the package’s June resubmission and during the FDA’s NDA review process.
- To clarify: This inclusion did not extend to the trial’s CSR.
Ah, gotcha. So now the CSR is in the FDA’s hands?
Indeed. Aldeyra submitted this to the agency on the same day as its Dec. 12 meeting.
Per the company: The FDA considered this submission to be “a major amendment to the NDA.”
Following this submission: The FDA reportedly “made no other requests and did not identify any other specific issues with the NDA review.”
That’s a relief to hear. Any other developments from this month to be aware of?
Aldeyra also reported that the FDA shared a draft of Aldeyra’s prospective label, to which it submitted a response.
Based on that: The FDA told Aldeyra that if no major issues are found during the extended review, the agency plans to send proposed labeling requests—and any expected postmarketing requirements—by Feb. 16.
- Notably: This is one month ahead of the extended PDUFA deadline.
So until 2026 … stay tuned for further updates on the situation!