A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

Start Date24 Jun 2024

Sponsor / Collaborator

Aldeyra Therapeutics, Inc.

NCT06424444 / RecruitingPhase 3

A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap

Start Date29 Apr 2024

Sponsor / Collaborator

Aldeyra Therapeutics, Inc.

NCT06389214 / CompletedPhase 3

Start Date09 Apr 2024

Sponsor / Collaborator

Aldeyra Therapeutics, Inc.

100 Clinical Results associated with Reproxalap

100 Translational Medicine associated with Reproxalap

100 Patents (Medical) associated with Reproxalap

Literatures (Medical) associated with Reproxalap

01 Aug 2022·Ophthalmology and TherapyQ3 · MEDICINE

Reproxalap Activity and Estimation of Clinically Relevant Thresholds for Ocular Itching and Redness in a Randomized Allergic Conjunctivitis Field Trial

Q3 · MEDICINE

ArticleOA

Author: Brady, Todd C ; Starr, Christopher E ; Cavanagh, Bill ; Gomes, Paul J ; Nichols, Kelly K

INTRODUCTIONThis clinical trial assessed the activity of reproxalap, a novel reactive aldehyde species modulator, and estimated clinically relevant thresholds for changes in ocular itching and redness in an allergic conjunctivitis field trial.METHODSThis was a randomized, double-masked, vehicle-controlled phase 2 trial. Patients with ragweed-associated allergic conjunctivitis were assessed over 28 days in an environmental setting with approximately four doses per day of either 0.25% reproxalap, 0.5% reproxalap, or vehicle. Patients recorded ocular itching, redness, tearing, and eyelid swelling scores (each with a 0-4 scale, except for a 0-3 scale for swelling), and completed the Allergic Conjunctivitis Quality of Life Questionnaire at the beginning and end of the trial.RESULTSMixed model of repeated measures analysis demonstrated statistically lower itching and tearing scores (pooled P = 0.026 and P < 0.001, respectively) and numerically lower redness and eyelid swelling scores than vehicle on days when pollen exceeded the 95th percentile value. Using three anchor-based and three distribution-based approaches, the meaningful within-patient change and the between-group meaningful difference for patient-reported ocular itching and redness was estimated to be approximately 0.5. The most common treatment-emergent adverse event associated with reproxalap was transient irritation upon instillation.CONCLUSIONIn a field clinical trial, reproxalap was well tolerated and superior to vehicle in reducing ocular itching on high-pollen days. The clinical meaningfulness threshold estimates of 0.5 units are among the first such calculations generated for the standard ocular itching and redness scores, providing important context for the clinical interpretation of clinical trials in allergic conjunctivitis.

01 Mar 2022·Molecular Genetics and Metabolism ReportsQ4 · MEDICINE

Sjögren-Larsson syndrome: A biochemical rationale for using aldehyde-reactive therapeutic agents

Q4 · MEDICINE

ArticleOA

Author: S'aulis, Dana ; Bailey, Zachary ; Dorwart, Elizabeth ; Rizzo, William B

Sjögren-Larsson syndrome (SLS) is a neurocutaneous disease caused by mutations in ALDH3A2 that result in deficient fatty aldehyde dehydrogenase (FALDH) activity and impaired fatty aldehyde and fatty alcohol oxidation. The pathogenesis of SLS is thought to involve accumulation of long-chain fatty aldehydes and alcohols and/or metabolically-related ether glycerolipids. Fatty aldehydes are particularly toxic molecules that can covalently react with proteins and certain amino-containing lipids such as phosphatidylethanolamine (PE), generating an unusual aldehyde adduct, N-alkyl-PE (NAPE). Using Faldh-deficient Chinese hamster ovary cells (FAA-K1A) as a cellular model for SLS, we investigated the ability of an aldehyde trapping agent, ADX-102 [2-(3-amino-6-chloro-quinolin-2-yl)-propan-2-ol], to mitigate the harmful effects of fatty aldehydes. FAA-K1A cells were protected from octadecanal (C18:0-al) induced cytotoxicity and apoptosis by ADX-102. Metabolism of C18:0-al to fatty alcohol (octadecanol) was also inhibited by ADX-102. FAA-K1A cells accumulated 5-fold more NAPE with C16- and C18-linked N-alkyl chains compared to wild-type cells, but NAPE levels decreased to normal after growth for 4 days with 50 μM ADX-102. Our results suggest that small aldehyde-reactive molecules, such as ADX-102, should be explored as novel therapeutic agents for SLS by preventing aldehyde adduct formation with critical cellular targets and inhibiting fatty aldehyde metabolism to fatty alcohol.

01 Oct 2021·American Journal of OphthalmologyQ2 · MEDICINE

Clinically Relevant Activity of the Novel RASP Inhibitor Reproxalap in Allergic Conjunctivitis: The Phase 3 ALLEVIATE Trial

Q2 · MEDICINE

Article

Author: Karpecki, Paul ; Cavanagh, Bill ; Shields, Alan L ; Sheppard, John ; Clark, David ; Brady, Todd C

PURPOSETo assess the post-acute activity and clinical utility of reproxalap, a novel reactive aldehyde species (RASP) inhibitor, versus vehicle in patients with seasonal allergic conjunctivitis.DESIGNParallel-group, double-masked, randomized Phase 3 trial.METHODSTwo topical ocular reproxalap concentrations (0.25% and 0.5%) were evaluated versus vehicle in patients with allergic conjunctivitis randomized 1:1:1 and treated with test article 10 minutes prior to conjunctival seasonal allergen challenge. The primary endpoint was area under the post-acute ocular itching score (range = 0-4) curve from 10 to 60 minutes after challenge. The key secondary endpoint was the proportion of subjects with ≥2 points improvement from their peak ocular itching score at baseline.RESULTSA total of 318 patients were randomized at 11 US sites. Both concentrations of reproxalap (0.25% and 0.5%) achieved the primary endpoint (P < .0001 and P = .003, respectively) and the key secondary endpoint (P = .0005 and P = .02, respectively). Time to complete resolution of ocular itching was statistically faster for both reproxalap concentrations than for vehicle (P < .0001 and P = .001, respectively). No safety or tolerability concerns were noted. The most common adverse event was mild and transient instillation site irritation.CONCLUSIONReproxalap was effective at reducing ocular itching in patients with allergic conjunctivitis. Reproxalap activity was clinically relevant, as assessed by responder-based and distributional analyses. ALLEVIATE represents one of the first allergic conjunctivitis Phase 3 trials of a novel mechanism of action in decades, and is unique among conjunctival allergen challenge trials in assessing clinical relevance with standard and validated techniques.

103

News (Medical) associated with Reproxalap

12 Aug 2024

·www.prnewswire.com

Ocumension (01477.HK) Demonstrates Strong Operational Resilience, Commercialization Capabilities Reach New Heights

SHANGHAI, Aug. 12, 2024 /PRNewswire/ -- On August 12, Ocumension Therapeutics (Shanghai) Co., Ltd. (01477.HK, hereinafter referred to as "Ocumension" or the "Company") released its 2024 Interim Results Report. During the reporting period, the company achieved operating revenue of RMB 168 million, representing a year-on-year increase of 61.6%. The gross margin was 59.2%, and the adjusted loss amounted to RMB 101 million, narrowing by 20.0% year-on-year. This significant growth in performance is attributed to the accelerated advancement of the company's commercialization process and the steady increase in market penetration. Additionally, the company's operational efficiency improved markedly, and its cost control capabilities were further optimized. Rapid Expansion of Core Products Leads to New Growth in the Ophthalmic Drug Market During the reporting period, the company's core products expanded rapidly, with ongoing efforts to build commercialization capabilities and continuously enhance core competitiveness. In the first half of the year, the company's commercialized products generated revenue of RMB 168 million, reflecting a year-on-year growth of 61.6%. Several products, including OT-204, OT-1004, and OT-306, all saw steady increases in market share, contributing to the strong market position of Ocumension in the ophthalmic drug market. Notably, one of the company's commercialized products, Yusheying® (for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye), was included in the National Medical Insurance Directory at the beginning of the year. The demand for this medication has rapidly increased over the past six months. Since the implementation of the new insurance directory, Yusheying® has completed nearly 2,000 injections in the first half of the year, showcasing its market potential and the high level of patient recognition. Furthermore, during the reporting period, Ocumension remained committed to broadening product accessibility to benefit a wider patient population. The company pursued a dual strategy: on one hand, it actively expanded hospital coverage and accelerated product hospitalizations to fully tap into the commercial potential of its mature products; on the other hand, it promoted new products through academic outreach, driving a leap in sales revenue. Nationally, the company has covered 10,970 hospitals, including 1,652 tertiary hospitals, supported by a professional commercial team of over 250 people. This extensive commercial network lays a solid foundation for the future market entry of Ocumension's ophthalmic product portfolio. In response to the increasing commercialization demand, Ocumension's Suzhou factory successfully initiated the first batch of commercial production of 0.3% Sodium Hyaluronate Eye Drops (0.4ml: 1.2mg) in July this year. Leveraging advanced manufacturing processes, efficient supply chain management, and a commitment to excellence, the first batch of "Ocumension-made" Sodium Hyaluronate Eye Drops will be produced at the fastest speed, bringing relief to patients suffering from dry eye syndrome. Strong R&D Capabilities, Comprehensive Development of Ophthalmic Drug Pipeline On July 5, a national plan supporting the development of innovative drugs throughout the entire chain was introduced. The central government has provided multi-dimensional support for the development of innovative drugs, which has greatly boosted market confidence. According to industry experts, the current surge in domestic R&D enthusiasm means that the strength of a company's R&D capabilities will be a key factor in determining its ability to stand out and succeed in this "marathon" race. According to the announcement, R&D expenses in the first half of 2024 reached RMB 59 million. Since its listing, Ocumension has prioritized investment in R&D, which, supported by its outstanding R&D capabilities and forward-looking strategic planning, has established its leading position in the field of ophthalmic drugs. This also provides the necessary ammunition for the company to rapidly capture the market in the future. Sustained and stable R&D investment ensures that Ocumension can steadily advance various R&D projects around its core product lines. During the reporting period, the allergic conjunctivitis drug OT-1001 (Cetirizine Hydrochloride Eye Drops) is expected to receive marketing approval soon; OT-101 (0.01% Atropine Sulfate Eye Drops) is progressing rapidly, with the first global patient in the Phase III MRCT having completed three years of treatment; OT-502 (Dexamethasone Implant) completed Phase III clinical trials and will soon submit an NDA; and the self-developed Class 1 new drug OT-202 (Spleen Tyrosine Kinase Inhibitor) for the treatment of dry eye syndrome completed Phase II clinical trials, achieving primary endpoints. In addition, OT-702 (Aflibercept Biosimilar) has completed Phase III clinical trials with positive results, and the NDA has been submitted to and accepted by the CDE. As an important component of Ocumension's commercialization strategy, OT-702 will effectively fill the gap in the company's portfolio for anti-VEGF drugs targeting retinal diseases. Leveraging the company's strong ophthalmic platform and extensive commercialization channels, this high-quality drug will be made available to more patients with retinal diseases. It is understood that the outstanding performance of anti-VEGF drugs in the treatment of retinal diseases has opened up a billion-dollar ophthalmic market. As more new ophthalmic drugs are developed in the future, the potential for market growth remains enormous. Currently, the company owns 25 drug assets targeting the anterior and posterior segments of the eye, including three products in Phase III clinical trials and three products in the registration phase for marketing approval. Ocumension remains one of the innovative pharmaceutical companies with the most products in Phase III clinical trials and the registration phase for marketing approval in the Chinese ophthalmic drug market. According to industry professionals, the company's continuous increase in R&D investment is a strong indicator of its profitability and demonstrates the company's strategic determination to drive development through innovation. By actively laying out product pipelines in niche areas and developing innovative drugs, the company is establishing a solid foundation for product line expansion and core product cultivation, contributing to its long-term sustainable development. Booming Ophthalmic Market Continues to Unleash Potential In recent years, the ophthalmic sector, as a representative of non-oncological fields, has attracted increasing interest from various companies. Pharmaceutical giants have been entering the ophthalmic sector one after another. In December 2023, Johnson & Johnson acquired a gene therapy for X-linked retinitis pigmentosa (XLRP) from MeiraGTx in a transaction valued at $415 million; in November 2023, AbbVie reached an agreement with Aldeyra, acquiring exclusive rights to the new dry eye disease drug Reproxalap for $401 million; in April 2023, Astellas invested $5.9 billion to acquire Iveric Bio, gaining access to a new drug for geographic atrophy, avacincaptad pegol; and at the end of 2022, Amgen acquired Horizon, securing Tepezza, a new drug for thyroid eye disease... Pharmaceutical giants have recognized the current transformation in the ophthalmic market's scale and structure, driven by the emergence of innovative technologies. As the aging population and widespread use of electronic devices increase the incidence of various eye diseases, Frost & Sullivan predicts that the global ophthalmic drug market will reach $46.4 billion by 2025 and $73.9 billion by 2030. In the future, as more clinical needs for ophthalmic diseases are explored and met, the market is poised for further explosive growth in various sub-segments. SOURCE OcuMension

Phase 3AcquisitionClinical Result

09 Aug 2024

·firstwordpharma.com

Aldeyra's dry-eye drug stages comeback with new Phase III results

Aldeyra Therapeutics says its small-molecule RASP modulator reproxalap has succeeded in a new Phase III dry-eye disease trial as its plots a second attempt at securing FDA approval after its first ended in a complete response letter (CRL) last November. The company, whose shares opened 11% higher on Friday, said it plans to refile an application this year."To our knowledge, the results announced today represent the first positive Phase III clinical trial in a dry-eye chamber with a symptom as a primary endpoint," stated CEO Todd Brady. "We believe that the results are supportive of the potential rapid clinical effect of reproxalap on reducing the ocular discomfort associated with dry-eye disease."In the trial, 132 patients were first given a version of the treatment without the active ingredient before and during exposure to a dry-eye chamber. Aldeyra said it believes the process follows guidelines set by the FDA for studying dry-eye disease. Patients who met the necessary criteria were later randomly assigned to receive either reproxalap or the inactive version again, during a second round of exposure to the dry environment.The trial was designed to satisfy the FDA's resubmission requirement, outlined in the CRL, which stated that Aldeyra had failed to demonstrate efficacy and called for "at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye."Aldeyra said reproxalap achieved the new study's primary endpoint of ocular discomfort (p=0.004), from 80 to 100 minutes in the dry-eye chamber. No safety signals were observed, with the most commonly reported adverse event being "mild and transient instillation-site discomfort." Moreover, there were no treatment-related discontinuations reported."Reproxalap is the first investigational drug with pivotal data supportive of acute and chronic activity in reducing symptoms, and the first investigational drug for chronic administration with pivotal data supportive of acute activity in reducing ocular redness," the company said.Prior to receiving the CRL last year, AbbVie struck a licensing agreement giving it rights to develop and commercialise reproxalap both inside and outside the US. Under that arrangement, Aldeyra is eligible for up to $300 million in regulatory and commercial milestone payments, inclusive of a $100-million payment if the FDA approves the drug for dry-eye disease.

Phase 3License out/inClinical Result

08 Aug 2024

·www.fiercebiotech.com

Aldeyra shows FDA-rejected reproxalap improves eye discomfort in new phase 3 study

Last year, the FDA denied approval for reproxalap, stating that Aldeyra failed to demonstrate "efficacy in treating ocular symptoms associated with dry eyes." After an FDA rejection last year, Aldeyra Therapeutics has scored a clinical win for dry eye drug reproxalap, which significantly reduced ocular discomfort in a new phase 3 study.Reproxalap is an investigational small molecule drug that was assessed among 132 patients exposed to a dry eye chamber. The ophthalmic solution hit the trial’s primary endpoint by demonstrating statistical superiority in ocular discomfort compared to vehicle—the drug product minus the active ingredient—after 80 to 100 minutes in the chamber, according to an Aug. 8 release. Ocular discomfort, or eye pain, is an FDA-accepted symptom of dry eye disease.“To our knowledge, the results announced today represent the first positive phase 3 clinical trial in a dry eye chamber with a symptom as a primary endpoint, and we believe that the results are supportive of the potential rapid clinical effect of reproxalap on reducing the ocular discomfort associated with dry eye disease,” Aldeyra President and CEO Todd Brady, M.D., Ph.D., said in the release.No safety signals were reported in the trial and reproxalap was well tolerated, according to Aldeyra. Near the end of last year, the FDA shut down Aldeyra’s ask to approve reproxalap in the same indication, telling the biotech in a complete response letter that the company had failed to demonstrate “efficacy in treating ocular symptoms associated with dry eyes,” Aldeyra explained at the time.The agency explained that efficacy could be shown with two symptom trials and two sign trials. Aldeyra had already undertaken two trials for ocular redness and a dry eye disease symptom trial. Aldeyra submitted a special protocol assessment to the FDA on Nov. 16 requesting a dry eye disease chamber crossover clinical trial similar to one the biotech had previously conducted.In the complete response letter, the FDA said the biotech needed “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye” to engage in the resubmission process, according to Aldeyra. The agency then provided feedback on the new clinical trial protocol and statistical plan.Participants in the trial that read out today received reproxalap or vehicle before and during chamber exposure in a way Aldeyra believes is consistent with the FDA’s dry eye disease draft guidance.The Lexington, Mass.-based company now expects to refile for approval sometime this year. The resubmission review period is expected to be six months. It’s been a rocky road for reproxalap thus far. Beyond the FDA snub, the drug has faced several other setbacks. In late 2021, Aldeyra reported that a phase 3 study missed the primary goal of improving ocular redness. The company switched up the main goal to focus on tear production, finding in June 2022 that the study was a success on that measure. That trial provided the underpinnings for Aldeyra’s initial approval request.Aldeyra is also developing reproxalap in allergic conjunctivitis, or eye allergies. In June 2023, the company snagged a phase 3 win in the area, with reproxalap demonstrating statistically significant reductions in eye itchiness. Before reproxalap’s rejection in dry eye disease, the biotech had said it intended to meet with the FDA to discuss a new drug filing for conjunctivitis in the first half of 2024.Still, AbbVie has seen potential in reproxalap, inking an exclusive option agreement in November 2023 for the rights to develop, manufacture and commercialize the drug. The deal is worth up to $300 million biobucks, including a $100 million milestone payment tied to FDA approval in dry eye disease.Aldeyra’s stock has risen 14% to $3.70 per share as of 10:30 a.m. ET today.

Phase 3Clinical ResultDrug ApprovalLicense out/in

100 Deals associated with Reproxalap

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Xerophthalmia	NDA/BLA	US	Aldeyra Therapeutics, Inc.	04 Oct 2024
Dry Eye Syndromes	Phase 3	CA	Aldeyra Therapeutics, Inc.	09 Apr 2024
Seasonal allergic conjunctivitis	Phase 3	CA	Aldeyra Therapeutics, Inc.	05 Dec 2019
Sjogren-Larsson Syndrome	Discovery	US	Aldeyra Therapeutics, Inc.	18 Jul 2018
Acute conjunctivitis	Discovery	US	Aldeyra Therapeutics, Inc.	30 Mar 2018
Conjunctivitis, Allergic	Discovery	US	Aldeyra Therapeutics, Inc.	30 Mar 2018
Non-infectious anterior uveitis	Discovery	US	Aldeyra Therapeutics, Inc.	26 Apr 2017
Rhinitis, Allergic, Seasonal	Discovery	CA	Aldeyra Therapeutics, Inc.	01 Aug 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06389214 (BusinessWire) Manual	Phase 3	Dry Eye Syndromes	132	0.25% reproxalap	hrjnrifiwb(xmaqwxkers): P-Value = 0.004 Met View more	Positive	08 Aug 2024
				vehicle
NCT05234554 (Phase III Clinical Trial, AAAAI2024)	Phase 3	Seasonal allergic conjunctivitis	-	Reproxalap Ophthalmic Solution (0.25%)	dxifyojwhv(decklpxlfc) = lqmvwdxpds rsmuiireof (hvalvmagvd ) View more	Positive	23 Feb 2024
				Vehicle	dxifyojwhv(decklpxlfc) = fcqtcsdzkp rsmuiireof (hvalvmagvd ) View more
NCT05234554 (INVIGORATE-2, Corporate Publications) Manual	Phase 3	Seasonal allergic conjunctivitis	131	Reproxalap	(qzfsdwjbst): P-Value = <0.0001 Met View more	Positive	15 Jun 2023
				Placebo
NCT02406209 (CTgov)	Phase 2	Non-infectious anterior uveitis	45	NS2 (NS2 Ophthalmic Drops (0.5%))	xisrzxftwn(hbmvsmblee) = rfvzdebgxr qsvglfkqns (judppmkvaq, habxnegvap - wgmdofjlhz) View more	-	27 Mar 2023
				Pred Forte+NS2 (NS2 (0.5%) and Pred Forte® (0.1%) Ophthalmic Drops)	xisrzxftwn(hbmvsmblee) = tpvaevfyhd qsvglfkqns (judppmkvaq, tvqmuwaycj - uvippadinb) View more
NCT03012165 (CTgov)	Phase 2	Conjunctivitis, Allergic	154	ADX-102 Ophthalmic Drops (0.5%) (ADX-102 Ophthalmic Drops (0.5%))	yqbegydwrm(cdaiwdddzu) = ddqiklhfiz zwucsklcpm (vckzzcmadn, xmnsznyqwj - jgnlntevrq) View more	-	09 Jan 2023
				ADX-102 Ophthalmic Drops (0.1%) (ADX-102 Ophthalmic Drops (0.1%))	yqbegydwrm(cdaiwdddzu) = mzijqpwsdp zwucsklcpm (vckzzcmadn, jucopinudv - cqzgjhuwnn) View more
NCT02402309 (CTgov)	Phase 2	Sjogren-Larsson Syndrome	12	Vehicle placebo 0.0% NS2 dermatologic cream	jfeseiytby(ginznzuifi) = kjabnoyouf crrhysvczu (fniigkgzrl, ynyomqidjm - fzqwqdobba) View more	-	13 Dec 2022
Corporate Publications Manual	Phase 2	Dry Eye Syndromes	63	reproxalap	(zideumivxd): P-Value = 0.0005 View more	Positive	12 Jul 2022
				Vehicle
NCT05062330 (TRANQUILITY‑2, BusinessWire) Manual	Phase 3	Dry Eye Syndromes	361	Reproxalap	(izxtsxivfw) = qgouzsirtn hrryysgpxm (iakitiezaa )	Positive	08 Jun 2022
				vehicle	(izxtsxivfw) = ukvvmbtxzm hrryysgpxm (iakitiezaa )
NCT05102409 (BusinessWire) Manual	Phase 2	Dry Eye Syndromes	56	Reproxalap	(xjvyoboheq): P-Value = 0.01 View more	Positive	11 Jan 2022
				Xiidra
NCT03404115 (Pubmed) Manual	Phase 2	Dry Eye Syndromes	300	ocular reproxalap	mmhxuncsyj(cfohrrqstm) = ybhpvzagxj qgrwqckgyy (hjzzqbvfmb ) View more	Positive	01 Jun 2021
				vehicle	-

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