COMPANY

Aldeyra Therapeutics, Inc.

HQ: Concord, MA source · aldeyra.com ↗ · New England

Keywords: ophthalmology Allergic Conjunctivitis Dry Eye Disease Dry Eye Dry Eye Syndromes Non-infectious Anterior Uveitis Alcohol Hepatitis Retinitis Pigmentosa Primary Vitreoretinal Lymphoma Proliferative Vitreoretinopathy Plaque Psoriasis Ethanol Intoxication Chronic Cough Atopic Asthma Covid19 Dry Eye Syndrome Atopic Dermatitis Nephrotic Syndrome Seasonal Allergies Sjogren-Larsson Syndrome Sjögren-Larsson Syndrome ADX-629 ADX-2191 ADX-102

Location: Concord, MA · source · Sep 29, 2026

Profile checked Oct 10, 2026

35Trials (company is sponsor)

Trial and FDA signals

FDA complete response letter Received an FDA complete response letter (NDA 216442, letter dated Mar 16, 2026). FDA NDA 216442 (Mar 16, 2026)
Evidence (1 event)
- Mar 16, 2026 · FDA NDA 216442
  CRL text (OCR, redacted by FDA; first 200 chars from "COMPLETE RESPONSE"): COMPLETE RESPONSE Aldeyra Therapeutics, Inc. Attention: David Noskowitz Regulatory Affairs Consultant Lexington, MA (street omitted) Dear David Noskowitz: Please refer to your new dr

Job counts as of Oct 18, 2026. All trial and FDA signals

Timeline

2026-02 Trial start Phase 3: A Clinical Trial Evaluating Patients With Primary Vitreoretinal Lymphoma source ↗
Nov 4, 2024 Trial start Phase 2: A Clinical Trial Investigating the Safety and Efficacy of Subjects With Alcohol Associated Hepatitis (Part 1) source ↗
Jun 24, 2024 Trial start Phase 3: A Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease source ↗
Apr 29, 2024 Trial start Phase 3: A Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease source ↗
Apr 9, 2024 Trial start Phase 3: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease source ↗
Feb 15, 2023 Trial start Phase 2: A Clinical Trial in Subjects With Atopic Dermatitis (Part 1) source ↗
2023-01 Trial start Phase 2: Part 1 - A Clinical Trial in Patients With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome source ↗
Jul 14, 2022 Trial start Phase 2: A Study in Subjects With Retinitis Pigmentosa source ↗
Apr 7, 2022 Trial start Phase 2: A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough source ↗
Mar 9, 2022 Trial start Phase 2: A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease source ↗
Jan 21, 2022 Trial start Phase 3: The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis source ↗
Nov 15, 2021 Trial start Phase 1/Phase 2: A Clinical Trial to Evaluate the Safety and Efficacy of ADX-629 in in Subjects With Elevated Ethanol Levels source ↗
Sep 9, 2021 Trial start Phase 2: An Exploratory Crossover Clinical Trial to Compare the Activity of Reproxalap and Lifitegrast in a Dry Eye Disease Chamber source ↗
Aug 28, 2021 Trial start 3: The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease source ↗
Jun 15, 2021 Trial start Phase 2: A Clinical Trial to Assess Subjects With Dry Eye Disease. source ↗
May 7, 2021 Trial start Phase 2: A Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Subjects With Plaque Psoriasis source ↗
Mar 31, 2021 Trial start Phase 2: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics for the Treatment of COVID-19. source ↗
Jan 26, 2021 Trial start Phase 3: A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease source ↗
Jan 9, 2021 Trial start Phase 2: A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of Subjects With Mild Asthma Induced by the Bronchial Allergen Challenge (BAC) source ↗
Nov 21, 2020 Trial start Phase 2/Phase 3: The TRANQUILITY Trial: Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease source ↗
Dec 5, 2019 Trial start Phase 3: The INVIGORATE Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis. source ↗
Nov 15, 2019 Trial start 3: The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy source ↗
Apr 23, 2019 Trial start Phase 2: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial of Reproxalap to Assess the Safety and Efficacy in Subjects With Dry Eye Disease source ↗
Apr 16, 2019 Trial start 3: The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease source ↗
Oct 2, 2018 Trial start Phase 1/Phase 2: A Methodology Development Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber source ↗

Showing 25 of 35 dated events.

Upcoming milestones

2026-12 (ESTIMATED) · Phase 3 · A Clinical Trial Evaluating Patients With Primary Vitreoretinal Lymphoma · NCT07402876

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 35

Record	Title	Phase	Status	Start	Primary completion
NCT06685692	A Clinical Trial Investigating the Safety and Efficacy of Subjects With Alcohol Associated Hepatitis (Part 1)	Phase 2	Completed	Nov 4, 2024	Jun 18, 2025 (actual)
NCT05234554	The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis	Phase 3	Completed	Jan 21, 2022	Apr 22, 2023 (actual)
NCT05392179	A Study in Subjects With Retinitis Pigmentosa	Phase 2	Completed	Jul 14, 2022	Jun 23, 2023 (actual)
NCT07402876	A Clinical Trial Evaluating Patients With Primary Vitreoretinal Lymphoma	Phase 3	Recruiting	2026-02	2026-12 (estimated)
NCT06493604	A Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease	Phase 3	Completed	Jun 24, 2024	Feb 27, 2025 (actual)
NCT04735393	A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease	Phase 3	Completed	Jan 26, 2021	Oct 11, 2022 (actual)
NCT06424444	A Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease	Phase 3	Completed	Apr 29, 2024	Nov 3, 2024 (actual)
NCT04136366	The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy	3	Completed	Nov 15, 2019	Jun 14, 2022 (actual)
NCT06389214	A Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease	Phase 3	Completed	Apr 9, 2024	Jun 11, 2024 (actual)
NCT03660878	A Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis	Phase 1/Phase 2	Completed	Sep 8, 2018	Nov 19, 2019 (actual)
NCT04674358	The TRANQUILITY Trial: Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease	Phase 2/Phase 3	Completed	Nov 21, 2020	Sep 12, 2021 (actual)
NCT05062330	The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease	3	Completed	Aug 28, 2021	Mar 4, 2022 (actual)
NCT04908514	A Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Subjects With Plaque Psoriasis	Phase 2	Completed	May 7, 2021	Jan 21, 2022 (actual)
NCT03916042	A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial of Reproxalap to Assess the Safety and Efficacy in Subjects With Dry Eye Disease	Phase 2	Completed	Apr 23, 2019	Nov 22, 2019 (actual)
NCT05487404	A Clinical Trial to Evaluate the Safety and Efficacy of ADX-629 in in Subjects With Elevated Ethanol Levels	Phase 1/Phase 2	Completed	Nov 15, 2021	May 29, 2022 (actual)
NCT05102409	An Exploratory Crossover Clinical Trial to Compare the Activity of Reproxalap and Lifitegrast in a Dry Eye Disease Chamber	Phase 2	Completed	Sep 9, 2021	Oct 25, 2021 (actual)
NCT05392192	A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough	Phase 2	Completed	Apr 7, 2022	Apr 13, 2023 (actual)
NCT03709121	A Methodology Development Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber	Phase 1/Phase 2	Completed	Oct 2, 2018	Mar 20, 2019 (actual)
NCT04971031	A Clinical Trial to Assess Subjects With Dry Eye Disease.	Phase 2	Completed	Jun 15, 2021	Sep 8, 2021 (actual)
NCT04728711	A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of Subjects With Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)	Phase 2	Completed	Jan 9, 2021	Jan 18, 2022 (actual)
NCT04847544	A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics for the Treatment of COVID-19.	Phase 2	Completed	Mar 31, 2021	Oct 15, 2021 (actual)
NCT03494504	ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis	3	Completed	Mar 30, 2018	Nov 5, 2018 (actual)
NCT03131154	SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.	3	Completed	Apr 26, 2017	Apr 19, 2019 (actual)
NCT03404115	A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease	Phase 2	Completed	Jan 2, 2018	Jul 11, 2018 (actual)
NCT03879863	The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease	3	Completed	Apr 16, 2019	Oct 4, 2019 (actual)
NCT03162783	A Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome	Phase 2	Completed	May 15, 2017	Jul 6, 2017 (actual)
NCT05424549	A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease	Phase 2	Completed	Mar 9, 2022	May 9, 2022 (actual)
NCT04207736	The INVIGORATE Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.	Phase 3	Completed	Dec 5, 2019	Feb 16, 2021 (actual)
NCT05717920	A Clinical Trial in Subjects With Atopic Dermatitis (Part 1)	Phase 2	Completed	Feb 15, 2023	Nov 21, 2023 (actual)
NCT05599815	Part 1 - A Clinical Trial in Patients With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome	Phase 2	Withdrawn	2023-01	2023-05 (estimated)
NCT02578914	A Safety and Activity Study of NS2 in Subjects With Allergic Conjunctivitis	Phase 2	Completed	2015-08	2015-12 (actual)
NCT02406209	A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis	Phase 2	Completed	2015-03	2016-04 (actual)
NCT03445650	RESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)	3	Completed	Jul 18, 2018	Jan 18, 2020 (actual)
NCT03012165	A Study of ADX-102 in Subjects With Allergic Conjunctivitis	Phase 2	Completed	2016-12	2017-05 (actual)
NCT02402309	A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS)	Phase 2	Completed	2015-03	2016-05 (actual)