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
ADX-2191 and Reproxalap. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ADX-2191 - FDA Regulatory Timeline and 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:
- April 25, 2024
- Indication:
- Primary vitreoretinal lymphoma (PVRL)
Announcement
Aldeyra Therapeutics, Inc will host the Aldeyra 2024 Research & Development Day with investors and financial analysts in New York City to present recent pipeline developments relating to the RASP modulation platform and ADX-2191 for the treatment of retinitis pigmentosa.
AI Summary
Aldeyra Therapeutics, Inc. will host the Aldeyra 2024 Research & Development Day in New York City, where investors and financial analysts are invited to hear about the latest advances in the company’s pipeline. During the event, Aldeyra will highlight recent developments related to its RASP modulation platform, which targets various inflammatory and metabolic conditions. A key focus of the presentation will be on the investigational product candidate ADX-2191, designed for the treatment of retinitis pigmentosa. The company plans to discuss preclinical data supporting ADX-2191’s potential efficacy and safety, as well as share insights into its strategy to initiate a pivotal Phase 2/3 clinical trial. This event underscores Aldeyra's commitment to addressing challenging diseases and providing new hope for patients suffering from retinitis pigmentosa, a condition that significantly impacts vision and quality of life.
Read Announcement
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:
- 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
- Estimated Event Date Range:
- April 2, 2025 - April 2, 2025
- Target Action Date:
- April 02, 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
- Estimated Event Date Range:
- July 1, 2024 - September 30, 2024
- Target Action Date:
- Q3 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- Drug:
- Reproxalap
- Announced Date:
- June 13, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 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:
- May 8, 2024
- Indication:
- Small-molecule modulator of RASP
Announcement
Aldeyra Therapeutics, Inc. announced enrollment of the first patient in a Phase 3 dry eye chamber clinical trial designed to enable a potential resubmission of the New Drug Application (NDA) of topical ocular 0.25% reproxalap, an investigational RASP modulator, for the treatment of dry eye disease.
AI Summary
Aldeyra Therapeutics, Inc. has reached an important milestone by enrolling the first patient in its Phase 3 dry eye chamber clinical trial. This study is a key step for the company as it works toward a potential resubmission of the New Drug Application (NDA) for its investigational treatment. The treatment, topical ocular 0.25% reproxalap, is a RASP modulator designed to address dry eye disease. By targeting the underlying causes of the condition, reproxalap could offer a promising new option for patients who suffer from chronic dry eye symptoms. The Phase 3 trial aims to generate the necessary data to support the NDA resubmission, signaling a major move forward in Aldeyra’s mission to advance innovative therapies for dry eye disease.
Read Announcement
