Submit New Drug Application for dry eye disease
Not delivered by the deadline
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- Announced
- 18 May 2022
- Due
- 30 Jun 2022
- Checked
- 2 Oct 2026
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Pending discussion with the FDA and enrollment of the ongoing 12-month safety trial in dry eye disease patients, NDA submission for dry eye disease is expected to occur mid-2022.”
What we found
Evidence strength A What the grades mean
The company did not submit the NDA by mid-2022, as filings from August 2022 indicate the submission was still pending further FDA discussions and a pre-NDA meeting scheduled for the third quarter.
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A Aldeyra Therapeutics, Inc. 10-Q filed 2022-08-05
“We are currently planning to submit an NDA to the FDA for reproxalap in DED in the second half of 2022” ✓ confirmed on the page
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A Aldeyra Therapeutics, Inc. 8-K filed 2022-08-05
“A pre-NDA meeting with the FDA to discuss the regulatory package has been scheduled for the third quarter of 2022.” ✓ confirmed on the page
Market reaction: the shares moved +20.1% against the S&P 500 over the three sessions around the disclosure (4 Aug 2022 to 9 Aug 2022). What this measures
Checked 2 Oct 2026.
Commitment lineage
Every time the company restated this commitment. The original is never changed, and the outcome is always measured against version 1.
- 1 versions
-
Version 1 · original · stated 18 May 2022
Deadline 30 Jun 2022 (“mid-2022”) · wording expected
-
Version 2 · stated 10 Nov 2022
Deadline 31 Dec 2022 (“the fourth quarter of 2022”)
“submit an NDA requesting marketing approval of the novel RASP modulator reproxalap in the fourth quarter of 2022”
-
Version 3 · stated 13 Jun 2024
Deadline 31 Dec 2024 (“in the second half of 2024”) · wording firm
“we remain on track to resubmit the dry eye disease NDA for reproxalap in the second half of 2024.”
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory submission
- Indicative materiality
- High rules
- Action
- Submit
- Deliverable
- New Drug Application
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- Medium
- Specificity
- Medium
- Conditional
- Yes: Pending discussion with the FDA; enrollment of the ongoing 12-month safety trial
- Depends on
- Regulatory
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Gemini (Google), read the company's later filings and recorded the outcome with a quoted passage.
- Second check: agreesA different AI model, Claude (Anthropic), re-read the evidence without being told the outcome and reached the same answer.
- Third check on a negative finding: agreesBecause a negative finding could harm a company if wrong, a stronger model re-read the evidence fully blind and reached the same answer.
Confirmed. This outcome counts towards the company's Kept Score. How verification works
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Report an error in this entry Reference: KI-C-2022-ALDX-003465 · Corrections policy