This section highlights FDA-related milestones and regulatory updates for drugs developed by Aldeyra Therapeutics (ALDX).
Over the past two years, Aldeyra Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Reproxalap, ADX‑629, and ADX-2191. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Reproxalap FDA Regulatory Timeline and Events
Reproxalap is a drug developed by Aldeyra Therapeutics for the following indication: Small-molecule modulator of RASP.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Reproxalap
- Announced Date:
- March 17, 2026
- Indication:
- Small-molecule modulator of RASP
Announcement
Aldeyra Therapeutics, Inc announced receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease.
AI Summary
Aldeyra Therapeutics announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration regarding its New Drug Application for reproxalap, an investigational treatment for dry eye disease. A CRL means the FDA has reviewed the application and determined it cannot be approved in its current form, listing issues or additional information needed before approval can proceed.
The company said it will review the FDA’s findings and decide on next steps, which could include providing more data, conducting further analyses, or resubmitting the application. The CRL creates uncertainty about timing for potential approval, and Aldeyra plans to communicate updates as it evaluates options and addresses the agency’s concerns.
Read Announcement- Drug:
- Reproxalap
- Announced Date:
- December 15, 2025
- Target Action Date:
- March 16, 2026
- Indication:
- Small-molecule modulator of RASP
Announcement
Aldeyra Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the reproxalap New Drug Application (NDA) for the treatment of dry eye disease. The extended PDUFA target action date is March 16, 2026.
AI Summary
Aldeyra Therapeutics said the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) target action date for the reproxalap New Drug Application (NDA) for dry eye disease. The new target action date is March 16, 2026. This date is when the FDA aims to complete its review and issue an action on the application.
The FDA notified Aldeyra that, if no major deficiencies are found during the extended review, it plans to communicate any proposed labeling requests and anticipated postmarketing requirements by February 16, 2026. This gives the company and investors a timeline for potential next steps from the agency.
Aldeyra will host a conference call and live webcast to discuss the PDUFA extension; dial-in numbers and a webcast are available on the company’s Investor Relations page at https://ir.aldeyra.com.
Read Announcement- Drug:
- Reproxalap
- Announced Date:
- July 17, 2025
- Target Action Date:
- December 16, 2025
- Indication:
- Small-molecule modulator of RASP
Announcement
Aldeyra Therapeutics, Inc announced that The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2025.
AI Summary
Aldeyra Therapeutics announced that the FDA has accepted its resubmitted new drug application for reproxalap, a novel treatment aimed at addressing dry eye disease symptoms. The agency has set a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2025, to decide whether to approve the drug.
The company emphasized that this timeline marks a critical milestone in the review process. The application is supported by data from a single clinical trial, which met its primary goal of reducing ocular discomfort compared to a placebo. Aldeyra is optimistic that reproxalap’s unique ability to reduce discomfort and redness in dry eye patients will offer an effective new treatment option. The firm looks forward to continuing its discussions with the FDA during the review process as it awaits the decision next December.
Read Announcement- Drug:
- Reproxalap
- Announced Date:
- July 17, 2025
- Indication:
- Small-molecule modulator of RASP
Announcement
Aldeyra Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease.
AI Summary
Aldeyra Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ocular reproxalap, a first-in-class investigational new drug candidate aimed at treating the signs and symptoms of dry eye disease. The resubmission included a single clinical trial that met its primary endpoint by significantly reducing ocular discomfort compared with a vehicle control. Reproxalap works by modulating reactive aldehyde species (RASP), molecules that play a role in inflammation, making it a promising treatment option in ophthalmology. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2025. In addition, Aldeyra highlighted that reproxalap is unique among investigational therapies, showing rapid activity during pivotal trials that simulated the acute symptom flares common in dry eye disease.
Read Announcement- Drug:
- Reproxalap
- Announced Date:
- June 17, 2025
- Indication:
- Small-molecule modulator of RASP
Announcement
Aldeyra Therapeutics, Inc. announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease.
AI Summary
Aldeyra Therapeutics announced that it has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug candidate, topical ocular reproxalap. This therapy is being developed to treat the signs and symptoms of dry eye disease. The resubmission includes new clinical data from a recently completed dry eye chamber trial that successfully met its primary endpoint, showing a statistically significant benefit compared to the vehicle control.
According to Aldeyra’s CEO, Todd C. Brady, M.D., Ph.D., the positive results support previous findings that suggest reproxalap can quickly improve dry eye symptoms. With the NDA now resubmitted, Aldeyra is optimistic that the updated clinical data will address prior concerns and move the drug closer to potential FDA review and approval.
Read Announcement- Drug:
- Reproxalap
- Announced Date:
- April 3, 2025
- Indication:
- Small-molecule modulator of RASP
Announcement
Aldeyra Therapeutics, Inc announced receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the resubmission of the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease.
AI Summary
Aldeyra Therapeutics, Inc. announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration regarding its resubmission of the New Drug Application for reproxalap, an investigational drug candidate aimed at treating dry eye disease. The FDA highlighted that while there were no concerns related to manufacturing or safety, the application did not provide sufficient evidence of efficacy in adequately controlled studies for treating ocular symptoms. Specifically, the agency requested that Aldeyra conduct at least one more well-controlled clinical study to clearly demonstrate a positive effect on these symptoms. The company plans to address the FDA’s concerns through additional clinical trials intended to strengthen the data package. Pending successful results and further discussions with the FDA, Aldeyra is targeting a mid-year 2025 resubmission of the NDA for reproxalap.
Read Announcement- Drug:
- Reproxalap
- Announced Date:
- November 18, 2024
- Target Action Date:
- April 2, 2025
- Indication:
- Small-molecule modulator of RASP
Announcement
Aldeyra Therapeutics Announces that PDUFA Date is April 2, 2025
AI Summary
Aldeyra Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for its innovative drug candidate, reproxalap, designed to treat the signs and symptoms of dry eye disease. The FDA has set the Prescription Drug User Fee Act (PDUFA) date for this application on April 2, 2025. This milestone marks a key step forward, as the agency’s review could lead to a new treatment option for patients suffering from dry eye.
The company’s announcement underscores its dedication to advancing new therapies in ocular care while also strengthening its collaboration with AbbVie. With reproxalap being positioned as a first-in-class therapy, Aldeyra is focused on delivering effective solutions for dry eye disease and potentially expanding its reach within the ophthalmic market through continued research and strategic partnerships.
Read Announcement- Drug:
- Reproxalap
- Announced Date:
- November 18, 2024
- Indication:
- Small-molecule modulator of RASP
Announcement
Aldeyra Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease.
AI Summary
Aldeyra Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review its resubmitted New Drug Application (NDA) for topical ocular reproxalap. This first-in-class investigational drug is being developed to treat the signs and symptoms of dry eye disease. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of April 2, 2025, as the target for completing its review process. The acceptance for review marks an important step forward in the regulatory process for reproxalap, which has been studied in a significant number of patients and has shown a favorable safety profile. Aldeyra’s focus remains on advancing innovative therapies, and the review of reproxalap could pave the way for a new treatment option for patients suffering from dry eye disease.
Read Announcement- Drug:
- Reproxalap
- Announced Date:
- October 3, 2024
- Indication:
- Small-molecule modulator of RASP
Announcement
Aldeyra Therapeutics, Inc announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease.
AI Summary
Aldeyra Therapeutics, Inc. recently announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration for its investigational product, topical ocular reproxalap. The application targets the treatment of signs and symptoms of dry eye disease, a condition that affects millions of people and can cause discomfort, blurred vision, and irritation. Reproxalap is designed to address the underlying inflammatory processes contributing to the disease, offering a fresh approach to managing dry eye symptoms. With this resubmission, Aldeyra aims to demonstrate the safety and effectiveness of the novel treatment option and further its development in addressing unmet medical needs in ophthalmology. The FDA review will be a crucial step in determining whether reproxalap can move forward toward providing significant relief for patients suffering from dry eye disease.
Read Announcement- Drug:
- Reproxalap
- Announced Date:
- August 8, 2024
- Indication:
- Small-molecule modulator of RASP
Announcement
Aldeyra Therapeutics, Inc nnounced the achievement of the primary endpoint in a Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber clinical trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate, for the treatment of dry eye disease.
AI Summary
Aldeyra Therapeutics, Inc. announced a major development in the treatment of dry eye disease. In a Phase 3 randomized, double-masked, vehicle-controlled trial, the investigational drug 0.25% reproxalap ophthalmic solution achieved its primary endpoint. The study was conducted in a dry eye chamber, focusing on reducing ocular discomfort – an FDA-recognized symptom of dry eye disease. Reproxalap was statistically superior to the vehicle control, marking a significant milestone as it is the first reported Phase 3 trial to meet this endpoint in a dry eye chamber setting.
These promising results support the potential for reproxalap to provide fast relief from ocular discomfort and strengthen its profile as a new treatment option for dry eye. The success of this trial lays the groundwork for further development and future regulatory submissions, advancing the possibility of a new and effective therapy for patients suffering from dry eye disease.
Read Announcement- Drug:
- Reproxalap
- Announced Date:
- June 13, 2024
- Target Action Date:
- H2 2024
- Estimated Target Date Range:
- July 1, 2024 - December 31, 2024
- Indication:
- Small-molecule modulator of RASP
Announcement
Aldeyra Therapeutics, Inc The trial is designed to enable potential resubmission of a dry eye disease New Drug Application (NDA) in the second half of 2024.
AI Summary
Aldeyra Therapeutics, Inc. recently completed enrollment in a Phase 3 clinical trial of its investigational drug, reproxalap, for dry eye disease. The trial evaluated the drug’s ability to reduce ocular discomfort, an important symptom for patients. Aldeyra is aiming to use the results from this study to support a potential resubmission of their New Drug Application (NDA) in the second half of 2024. This effort is part of a broader strategy to address the unmet needs of dry eye patients by demonstrating both acute and chronic improvements in symptoms, as well as a reduction in ocular redness. If approved, this treatment could mark a significant advancement by being among the first dry eye disease therapies to utilize data from an acute dry eye chamber assessment alongside long-term clinical benefits. The company expects to have more data available by the third quarter of 2024.
Read Announcement- Drug:
- Reproxalap
- Announced Date:
- June 13, 2024
- Target Action Date:
- Q3 2024
- Estimated Target Date Range:
- July 1, 2024 - September 30, 2024
- Indication:
- Small-molecule modulator of RASP
Announcement
Aldeyra Therapeutics, Inc. announced that anticipate receiving results from the clinical trial in the third quarter of 2024
AI Summary
Aldeyra Therapeutics, Inc. has completed enrollment in its Phase 3 clinical trial for the dry eye treatment reproxalap. This trial enrolled 132 patients to assess the drug’s effect on reducing ocular discomfort in patients with dry eye disease. Aldeyra is now moving forward with a plan to potentially resubmit a New Drug Application in the second half of 2024 if the trial results turn out positive.
The company anticipates receiving the clinical trial results in the third quarter of 2024. If these results are favorable, they intend to include a draft label in the resubmission that outlines both acute and chronic improvements in symptoms, as well as a reduction in ocular redness. Aldeyra’s progress in this trial reflects their efforts to address an unmet need for effective dry eye treatments.
Read Announcement- Drug:
- Reproxalap
- Announced Date:
- June 13, 2024
- Indication:
- Small-molecule modulator of RASP
Announcement
Aldeyra Therapeutics, Inc. announced the completion of enrollment in a Phase 3 dry eye chamber clinical trial of topical ocular 0.25% reproxalap, an investigational RASP modulator, for the treatment of dry eye disease.
AI Summary
Aldeyra Therapeutics, Inc. announced that it has completed enrollment in a Phase 3 dry eye chamber clinical trial testing its investigational RASP modulator, topical ocular 0.25% reproxalap, for the treatment of dry eye disease. In this study, 132 patients were enrolled to assess the primary endpoint of reducing ocular discomfort. The trial began enrolling patients in May 2024 and is an important step toward supporting a potential resubmission of a New Drug Application later this year, expected in the second half of 2024. If the trial results are positive—results anticipated in the third quarter—they may allow Aldeyra to present clinical data showing both acute and chronic improvements in dry eye symptoms, including a reduction in ocular redness. The company believes this study addresses an unmet medical need for patients suffering from dry eye disease.
Read Announcement
ADX‑629 FDA Regulatory Events
ADX‑629 is a drug developed by Aldeyra Therapeutics for the following indication: For Treatment of chronic cough.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ADX‑629
- Announced Date:
- October 28, 2025
- Indication:
- For Treatment of chronic cough
Announcement
Aldeyra Therapeutics, Inc. announced achievement of statistically significant improvement in liver function in patients treated with ADX-629, an investigational new drug candidate, and focused the RASP modulator product candidate pipeline on next-generation molecules ADX-248 and ADX-246.
AI Summary
Aldeyra Therapeutics, Inc. announced that in a Phase 2 trial, its investigational RASP modulator ADX-629 led to improvements in liver function for patients with mild to moderate alcohol-associated hepatitis. After a month of oral dosing, patients showed statistically significant drops in MELD scores, triglycerides, and C-reactive protein levels. No adverse events were reported.
These results mark a successful proof of concept for ADX-629 and support a shift in Aldeyra’s pipeline toward its next-generation RASP modulators. The company is now focusing on ADX-248 and ADX-246.
ADX-248, designed for metabolic inflammation such as obesity and high triglycerides, and ADX-246, aimed at dry age-related macular degeneration, are in development. Both are expected to file IND applications in 2026.
With these updates, Aldeyra says its cash runway now extends into the second half of 2027. The company remains committed to developing RASP modulators for immune-mediated diseases.
Read Announcement
ADX-2191 FDA Regulatory Events
ADX-2191 is a drug developed by Aldeyra Therapeutics for the following indication: Primary vitreoretinal lymphoma (PVRL).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ADX-2191
- Announced Date:
- August 19, 2025
- Indication:
- Primary vitreoretinal lymphoma (PVRL)
Announcement
Aldeyra Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for ADX-2191 (methotrexate intravitreal injection, USP) for the treatment of retinitis pigmentosa.
Read Announcement- Drug:
- ADX-2191
- Announced Date:
- July 24, 2025
- Indication:
- Primary vitreoretinal lymphoma (PVRL)
Announcement
Aldeyra Therapeutics, Inc. announced that the European Medicines Agency (EMA) has granted Orphan Designation for ADX-2191 (methotrexate intravitreal injection) for the treatment of inherited retinal dystrophies of the rod-dominant phenotype, including retinitis pigmentosa.
AI Summary
Aldeyra Therapeutics announced that the European Medicines Agency (EMA) has granted Orphan Designation for ADX-2191, a methotrexate intravitreal injection, to treat inherited retinal dystrophies of the rod-dominant phenotype, including retinitis pigmentosa.
Retinitis pigmentosa is a rare genetic eye disease marked by the gradual death of retinal cells and progressive vision loss. It affects more than one million people worldwide, and there are currently no approved drug treatments for most forms of the disease.
Support for ADX-2191 comes from a Phase 2 clinical trial in 2023, which showed improvements in retinal sensitivity from baseline. Aldeyra plans to start a combined Phase 2/3 trial in 2025 to further assess safety and effectiveness.
The EMA’s Orphan Designation offers benefits such as reduced regulatory fees, scientific advice, research grants, and up to ten years of market exclusivity in the European Union, highlighting the urgent need for new therapies in this field.
Read Announcement
