The FDA has accepted for review Aldeyra Therapeutics, Inc.’s resubmitted new drug application (NDA) for reproxalap, intended to treat the signs and symptoms of dry eye disease (DED).
I could’ve sworn we just heard about this …
You did. Last month, in fact, when that NDA was submitted to the federal agency for the third time.
This FDA response was expected, as resubmitted NDAs require the agency to acknowledge acceptance within 30 days.
Dare I ask for a recap of what’s led up to the newest submission?
You certainly could. However, at the risk of being redundant (and less brief), we’d much rather direct you toward our previous coverage of this situation.
In a nutshell: Aldeyra has experienced two FDA rejections (receiving two company response letters), conducted additional phase 3 dry eye chamber trials, and collected new supporting clinical data in its efforts to push ocular reproxalap toward market approval.
Got it. How about a little rundown on reproxalap?
The candidate is a small-molecule modulator of reactive aldehyde species (RASP) under clinical development for DED and allergic conjunctivitis (AC).
- See here for details on RASP as well as Aldeyra’s RASP Modulator Platform,
Its efficacy: Once topically applied, reproxalap works to reduce DED symptoms within minutes—and lasts up to 12 weeks.
And the clinical data on it?
There’s plenty—five clinical trials and almost 3,000 patients’ worth of data across both its investigational indications over the last few years.
And more recently: Findings from a phase 3 dry eye chamber trial reported in August 2024 offered additional supporting data in reducing ocular redness and discomfort. Check it out here.
Was that data included in this new NDA submission?
No, actually. That data actually came from yet another phase 3 dry eye chamber trial—and was the only new clinical data included in the resubmitted application (compared to the data included in its previous two attempts).
- See here for details on those findings, which included reproxalap demonstrating statistically superior efficacy (versus vehicle) in reducing ocular discomfort, as well as there being no major difference in baseline scores between treatment arms.
Why was that last finding crucial?
Largely because the data on this piece addressed prior concerns and issues the FDA had raised to the company in its previous NDA submission. See here for a breakdown of that situation.
So! What happens next?
Now we wait for the FDA to spend the next near-5 months reviewing this updated application and determine whether or not to grant reproxalap marketing approval.
To be more specific regarding this waiting period, the agency assigned a Prescription Drug User Fee Act (PDUFA) target action date of Dec. 16, 2025.
As always, stay tuned!