reproxalap ophthalmic (ADX-102 ophthalmic) / Aldeyra, Ligand - LARVOL DELTA

Aldeyra Therapeutics, Inc. (ALDX) Faces Scrutiny After Stock Drops 70% On FDA’s Reproxalap Complete Response Letter – Hagens Berman (GlobeNewswire) - "On April 3, 2025 investors in Aldeyra Therapeutics...saw the price of their shares crash over 70% after the company announced that it received a Complete Response Letter ('CRL') from the FDA for the resubmission of the New Drug Application ('NDA') of reproxalap, an investigational drug candidate, for the treatment of dry eye disease."

CRL • Stock price • Dry Eye Disease

Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Signs and Symptoms of Dry Eye Disease (Aldeyra Therapeutics Press Release) - "Aldeyra Therapeutics...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...Although no manufacturing or safety issues with reproxalap were identified, the FDA stated in the letter that the NDA 'failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes' and that 'at least one additional adequate and well controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye' should be conducted....In the second quarter of 2025, Aldeyra expects to announce top-line results from the ongoing dry eye disease field trial and the ongoing chamber clinical trial. Subject to positive results and discussions with the FDA, Aldeyra intends to resubmit the NDA mid-year 2025. The review period for the potential NDA resubmission is expected to be six months."

CRL • FDA filing • P3 data: top line • Dry Eye Disease

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 (clinicaltrials.gov) - P2 | N=300 | Completed | Sponsor: Aldeyra Therapeutics, Inc. | Phase classification: P2b ➔ P2

Phase classification • Dry Eye Disease • Ophthalmology

A Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome (clinicaltrials.gov) - P2 | N=51 | Completed | Sponsor: Aldeyra Therapeutics, Inc. | Phase classification: P2a ➔ P2

Phase classification • Dry Eye Disease • Ophthalmology

Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye Disease, Expands AbbVie Option Agreement (Businesswire) - "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. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of April 2, 2025. In conjunction with the acceptance of the NDA for review, Aldeyra announced the expansion of its exclusive option agreement with AbbVie Inc. (AbbVie)."

FDA filing • PDUFA • Dry Eye Disease • Ophthalmology

Quintessence of currently approved and upcoming treatments for dry eye disease. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "Currently, the US Food and Drug Administration (FDA)-approved medical treatments for treatment of DED include cyclosporine formulations (RESTASIS® [cyclosporine 0.05% ophthalmic emulsion], VEVYE® [cyclosporine 0.1% ophthalmic solution], and CEQUA™ [cyclosporine 0.09% ophthalmic solution]), XIIDRA® (lifitegrast), a leukocyte function-associated antigen-1 (LFA-1)/intracellular adhesion molecule-1(ICAM-1) inhibitor, EYSUVIS™ (loteprednol etabonate ophthalmic suspension 0.25%), a corticosteroid, and MIEBO™ (perfluorohexyloctane ophthalmic solution), a semifluorinated alkane. TYRVAYA™ (varenicline solution nasal spray), a cholinergic agonist, is another formulation approved for the treatment of the signs and symptoms of DED...Cyclosporine formulations TJO-087 (cyclosporine A nanoemulsion 0.08%), SCAI-001 eye drops (cyclosporine 0.01%, 0.02%) are being evaluated against RESTASIS® and other approved treatments. The potential treatments being assessed include..."

Journal • Review • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome • ICAM1

Reproxalap ophthalmic : “The phase 3 dry eye chamber clinical trial achieved the primary endpoint of ocular discomfort”; Dry eye disease (Aldeyra Therapeutics) - Phase 3 Dry Eye Disease Clinical Trial of Reproxalap

P3 data: top line • Dry Eye Disease • Ophthalmology

A Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease (clinicaltrials.gov) - P3 | N=110 | Recruiting | Sponsor: Aldeyra Therapeutics, Inc.

New P3 trial • Dry Eye Disease • Ophthalmology

A Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease (clinicaltrials.gov) - P3 | N=132 | Completed | Sponsor: Aldeyra Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Jun 2024 | Trial primary completion date: Dec 2024 ➔ Jun 2024

Trial completion • Trial completion date • Trial primary completion date • Dry Eye Disease • Ophthalmology

Reproxalap ophthalmic: NDA resubmission in US for dry eye disease in H2 2024 (Aldeyra Therapeutics) - Research & Development Day 2024

FDA filing • Dry Eye Disease • Ophthalmology

Reproxalap ophthalmic: Top-line data from P3 trial (NCT04735393) for dry eye disease in H2 2024 (Aldeyra Therapeutics) - Research & Development Day 2024

P3 data: top line • Dry Eye Disease • Ophthalmology

A Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Aldeyra Therapeutics, Inc.

New P3 trial • Dry Eye Disease • Ophthalmology

A Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease (clinicaltrials.gov) - P3 | N=110 | Recruiting | Sponsor: Aldeyra Therapeutics, Inc.

New P3 trial • Dry Eye Disease • Ophthalmology

A Replicate Phase III Clinical Trial to Assess the Reproducibility of Efficacy and Safety of Reproxalap Ophthalmic Solution (0.25%) Compared to Vehicle in Participants With Seasonal Allergic Conjunctivitis (AC) Using the Environmental Exposure Chamber (EEC) (AAAAI 2024) - P3 | "These data show that for two studies conducted over different years in different subjects that results are highly replicative when conducted in an EEC. The EEC demonstrates reproducible and safe approach to allergy drug testing in Phase III and reduces the potential for trial failure due to challenges such as COVID-19 or erratic pollen seasons with climate change."

Clinical • P3 data • Allergy • Conjunctivitis • Immunology • Infectious Disease • Novel Coronavirus Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Pruritus

The Phase 3 INVIGORATE Trial of Reproxalap in Patients with Seasonal Allergic Conjunctivitis. (PubMed, Clin Ophthalmol) - P3 | "In this well-controlled allergen chamber trial, reproxalap was statistically superior to vehicle across typical symptoms and signs of allergic conjunctivitis. NCT04207736."

Clinical • P3 data • Allergy • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Dry Eye Disease (Businesswire) - "Aldeyra Therapeutics...today announced receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of reproxalap...The SPA review cycle is anticipated to be 45 days, and Aldeyra expects FDA feedback from the SPA in December of 2023...top-line results are anticipated in the first half of 2024, subject to FDA feedback on the SPA....The potential NDA resubmission is anticipated in the first half of 2024, pending FDA SPA feedback and positive results from the proposed trial....Aldeyra plans to conduct a Type C meeting with the FDA in the first half of 2024 to discuss the potential NDA submission of reproxalap for the treatment of allergic conjunctivitis....Aldeyra is extending previous cash runway guidance into late 2025, including clinical trial costs associated with the proposed trial and potential NDA resubmission; the initial commercialization and launch plans for reproxalap, if approved in late 2024..."

FDA event • Launch • NDA • P3 data: top line • Conjunctivitis • Dry Eye Disease

The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis (clinicaltrials.gov) - P3 | N=131 | Completed | Sponsor: Aldeyra Therapeutics, Inc. | Recruiting ➔ Completed | N=58 ➔ 131

Enrollment change • Trial completion • Conjunctivitis • Ocular Infections • Ocular Inflammation • Ophthalmology

Aldeyra Therapeutics Announces Achievement of Statistical Significance for Primary Endpoint and All Secondary Endpoints in Phase 3 INVIGORATE‑2 Trial of Reproxalap in Allergic Conjunctivitis (Businesswire) - "A New Drug Application (NDA) of reproxalap for the treatment of dry eye disease is under review at the U.S. Food and Drug Administration. The NDA Prescription Drug User Fee Act (PDUFA) date for reproxalap for the treatment of dry eye disease is November 23, 2023."

FDA event • PDUFA date • Dry Eye Disease • Ophthalmology

Reproxalap, a Novel Rasp Modulator, Rapidly Improves Tear Production in the Phase 3 Tranquility-2 Trial (ASCRS-ASOA 2023) - "Reproxalap rapidly increased tear production, as assessed by Schirmer test, within 10 minutes of dosing compared to vehicle.The clinical relevance of the Schirmer test results were confirmed with ≥10 mm Schirmer test responder analyses.Reproxalap may represent a novel, rapidly acting therapeutic approach for the treatment of dry eye disease."

P3 data • Dry Eye Disease • Ophthalmology

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 (clinicaltrials.gov) - P3 | N=757 | Completed | Sponsor: Aldeyra Therapeutics, Inc. | Recruiting ➔ Completed | N=525 ➔ 757 | Trial completion date: Jun 2022 ➔ Oct 2022 | Trial primary completion date: Jun 2022 ➔ Oct 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Dry Eye Disease • Ophthalmology

A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease (clinicaltrials.gov) - P2 | N=63 | Completed | Sponsor: Aldeyra Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Oct 2022 ➔ May 2022 | Trial primary completion date: Oct 2022 ➔ May 2022

Trial completion • Trial completion date • Trial primary completion date • Dry Eye Disease • Ophthalmology

The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease (clinicaltrials.gov) - P3 | N=361 | Completed | Sponsor: Aldeyra Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Jun 2022 ➔ Mar 2022 | Trial primary completion date: Jun 2022 ➔ Mar 2022

Trial completion • Trial completion date • Trial primary completion date • Dry Eye Disease • Ophthalmology

A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Aldeyra Therapeutics, Inc.

New P2 trial • Dry Eye Disease • Ophthalmology

An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease (clinicaltrials.gov) - P2 | N=56 | Completed | Sponsor: Aldeyra Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Apr 2022 ➔ Oct 2021 | Trial primary completion date: Apr 2022 ➔ Oct 2021

Trial completion • Trial completion date • Trial primary completion date • Dry Eye Disease • Ophthalmology

The Novel RASP Modulator Reproxalap Rapidly Improves Signs and Symptoms of Dry Eye Disease: The TRANQUILITY Run-In Cohort (ASCRS-ASOA 2022) - "The most common adverse event in drug-treated subjects was transient and mild instillation site discomfort. Conclusion Against a backdrop of current topical non-corticosteroid ocular therapies that require weeks to evidence activity, reproxalap may represent a novel, rapidly acting option for patients suffering from dry eye disease."

Dry Eye Disease • Ophthalmology