Opus Genetics Doses First Patient in Pivotal LYNX-3 Phase 3 Trial Evaluating Phentolamine Ophthalmic Solution 0.75% in Keratorefractive Patients With Visual Disturbances Under Mesopic, Low-Contrast Conditions
Opus Genetics (Nasdaq: IRD) has initiated dosing in LYNX-3, its pivotal Phase 3 clinical trial for Phentolamine Ophthalmic Solution 0.75%. The trial aims to evaluate the treatment's efficacy in keratorefractive patients experiencing night driving impairment and reduced mesopic vision.
The trial, which received FDA Fast Track designation and is being conducted under Special Protocol Assessment (SPA), follows the successful LYNX-2 Phase 3 trial that reported positive topline results in June 2025. The drug is designed to moderately reduce pupil size in low-light conditions, potentially addressing common post-LASIK visual disturbances like glare, halos, and starbursts, for which no FDA-approved treatments currently exist.
Opus Genetics (Nasdaq: IRD) ha iniziato la somministrazione nel trial LYNX-3, il suo studio clinico pivotale di Fase 3 per la soluzione oftalmica di fentolamina allo 0,75%. Lo studio valuta l'efficacia del trattamento nei pazienti keratorefrattivi con difficoltà alla guida notturna e ridotta visione mesopica.
Il trial, che ha ottenuto la designazione FDA Fast Track ed è condotto secondo una Special Protocol Assessment (SPA), segue il positivo esito topline del trial LYNX-2 di Fase 3 annunciato nel giugno 2025. Il farmaco è studiato per ridurre moderatamente il diametro pupillare in condizioni di scarsa illuminazione, potenzialmente alleviando disturbi visivi post-LASIK come abbagliamento, aloni e “starbursts”, per i quali attualmente non esistono terapie approvate dalla FDA.
Opus Genetics (Nasdaq: IRD) ha comenzado a administrar dosis en LYNX-3, su ensayo pivotal de fase 3 para la solución oftálmica de fentolamina al 0,75%. El estudio busca evaluar la eficacia del tratamiento en pacientes keratorefractivos que presentan dificultades al conducir de noche y disminución de la visión mesópica.
El ensayo, que recibió la designación FDA Fast Track y se realiza bajo una Special Protocol Assessment (SPA), sigue al exitoso ensayo LYNX-2 de fase 3 que reportó resultados topline positivos en junio de 2025. El fármaco está diseñado para reducir moderadamente el tamaño pupilar en condiciones de baja iluminación, con el objetivo de abordar molestias visuales comunes después de LASIK, como deslumbramiento, halos y “starbursts”, para las cuales actualmente no existen tratamientos aprobados por la FDA.
Opus Genetics (나스닥: IRD)가 중요한 임상시험 LYNX-3에서 투약을 시작했습니다. 해당 시험은 페نت올아민 안약 0.75%의 3상 결정적 임상시험으로, 야간 운전 장애와 감광(메소픽) 시력 저하를 겪는 각막굴절수술 환자에서 약물의 효능을 평가하는 것을 목표로 합니다.
본 임상은 FDA 패스트트랙 지정을 받았고 Special Protocol Assessment(SPA) 하에 진행되며, 2025년 6월에 긍정적인 톱라인 결과를 보고한 LYNX-2 3상 시험의 성공을 바탕으로 합니다. 이 약물은 저조도 환경에서 동공 크기를 적당히 줄이도록 설계되어, 현재 FDA 승인 치료제가 없는 라식 후 흔한 시각 이상(눈부심, 빛무리 및 별무리 현상 등)을 완화할 가능성이 있습니다.
Opus Genetics (Nasdaq : IRD) a débuté les premières administrations dans LYNX-3, son essai pivot de phase 3 pour la solution ophtalmique de phentolamine à 0,75 %. L'étude vise à évaluer l'efficacité du traitement chez les patients kérato-réfractifs souffrant de gêne à la conduite nocturne et d'une vision mésopique diminuée.
L'essai, qui a reçu la désignation FDA Fast Track et qui est mené dans le cadre d'une Special Protocol Assessment (SPA), fait suite aux résultats topline positifs du LYNX-2, essai de phase 3 publiés en juin 2025. Le médicament est conçu pour réduire modérément le diamètre pupillaire en conditions de faible luminosité, pouvant ainsi traiter des troubles visuels post-LASIK fréquents tels que l'éblouissement, les halos et les « starbursts », pour lesquels il n'existe actuellement aucun traitement approuvé par la FDA.
Opus Genetics (Nasdaq: IRD) hat mit der Dosierung im LYNX-3-Studienarm begonnen, seiner entscheidenden Phase-3-Studie für die phentolamin-haltige ophthalmische Lösung 0,75%. Die Studie zielt darauf ab, die Wirksamkeit der Behandlung bei keratorefraktiven Patienten mit Beeinträchtigungen beim nächtlichen Fahren und verringerter mesopischer Sicht zu prüfen.
Die Studie, die die FDA-Fast-Track-Zulassung erhalten hat und unter einer Special Protocol Assessment (SPA) durchgeführt wird, folgt auf die positiven Topline-Ergebnisse der LYNX-2 Phase-3-Studie vom Juni 2025. Das Medikament ist darauf ausgelegt, bei schwachem Licht die Pupillengröße moderat zu reduzieren und damit häufige nach LASIK auftretende Sehbeschwerden wie Blendung, Halos und Sternstrahlen zu adressieren, für die derzeit keine von der FDA zugelassenen Behandlungen existieren.
- FDA Fast Track designation and Special Protocol Assessment (SPA) secured for the trial
- Positive topline results already achieved in previous LYNX-2 Phase 3 trial
- Addresses unmet medical need with no current FDA-approved treatment options
- Drug already has one approved indication for mydriasis reversal
- Phase 3 trials still ongoing with no guaranteed success
- Timeline to potential FDA approval not specified
Insights
Opus Genetics' Phase 3 trial advances potential first-in-class therapy for post-LASIK night vision issues, building on prior positive results.
Opus Genetics has initiated patient dosing in its pivotal LYNX-3 Phase 3 trial for Phentolamine Ophthalmic Solution 0.75%, targeting night vision disturbances in post-keratorefractive surgery patients. This represents significant clinical progress as it's the second Phase 3 trial for this indication, with the first (LYNX-2) already reporting positive topline results in June 2025. The FDA has granted this program Fast Track designation and approved a Special Protocol Assessment, both regulatory advantages that can accelerate approval pathways.
The mechanistic approach is elegant yet straightforward - Phentolamine acts as a non-selective α1/α2 adrenergic antagonist that moderately reduces pupil size in low-light conditions. This targeted pupillary constriction potentially reduces aberrant light rays from entering the peripheral cornea where post-surgical aberrations are most pronounced, while maintaining central retinal sensitivity. This addresses a significant unmet need, as millions of post-LASIK and refractive surgery patients experience night vision disturbances like glare, halos, and starbursts, with no current FDA-approved treatments.
Notably, this represents the third potential indication for Phentolamine, which already has approval for reversal of drug-induced mydriasis and positive Phase 3 data for presbyopia. This multi-indication strategy significantly enhances the commercial potential of a single molecule. If successful across these indications, Phentolamine could become a versatile ophthalmic solution addressing multiple vision disorders with a single pharmacological approach.
RESEARCH TRIANGLE PARK, N.C., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage biopharmaceutical company developing gene therapies for inherited retinal diseases (IRDs) and small-molecule therapies for other ophthalmic disorders, today announced that the first patient has been dosed in LYNX-3, the Company’s pivotal Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution
LYNX-3 is the second Phase 3 trial for this indication with Fast Track designation from the U.S. Food and Drug Administration (FDA) and is being conducted under a Special Protocol Assessment (SPA). Positive topline results from the first Phase 3 trial, LYNX-2, were announced in June 2025.
Night-vision disturbances, which can include glare, halos, and starbursts, are common in some patients after keratorefractive procedures such as LASIK and currently have no FDA-approved treatment options. Phentolamine Ophthalmic Solution
“Dosing the first patient in LYNX-3 is a significant milestone for our Phentolamine program, which already has one approved indication for the reversal of drug-induced mydriasis, positive Phase 3 data in potentially treating presbyopia, and now an ongoing Phase 3 trial for keratorefractive patients with visual disturbances under mesopic, low-contrast conditions,” said George Magrath, M.D., Chief Executive Officer, Opus Genetics. “These positive Phase 3 data represent the opportunity to address a critical need for millions of patients affected by these symptoms.”
“Even after otherwise successful refractive surgery, such as LASIK, some patients can experience visual quality challenges in low-light conditions,” said Jay Pepose, M.D., Ph.D., Chief Medical Advisor, Opus Genetics. “Following the positive results from LYNX-2, the LYNX-3 study is the second pivotal Phase 3 study designed to further evaluate whether Phentolamine Ophthalmic Solution
About LYNX-3
LYNX-3 is a multicenter, randomized, double-masked, placebo-controlled Phase 3 trial that will enroll approximately 200 adults with documented decreased visual acuity in mesopic (low-light) conditions following keratorefractive surgery, including Laser-Assisted In Situ Keratomileusis (LASIK), Photorefractive Keratectomy (PRK), Small-Incision Lenticule Extraction (SMILE), Radial Keratotomy (RK). Participants will be randomized 1:1 to receive once-daily evening dosing of Phentolamine Ophthalmic Solution
The primary endpoint is the percentage of participants achieving a ≥15-letter Early Treatment Diabetic Retinopathy Study (ETDRS) (≥3-line) improvement from baseline in mesopic low-contrast visual acuity (mLCVA) in the study eye at Day 15. Key secondary endpoints include patient-reported outcomes related to night driving, glare, halos, and starbursts, as well as binocular visual function measures. Safety assessments will include ocular and systemic evaluations.
About Phentolamine Ophthalmic Solution
Phentolamine Ophthalmic Solution
About Opus Genetics
Opus Genetics is a clinical-stage biopharmaceutical company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders. The Company’s pipeline features AAV-based gene therapies targeting inherited retinal diseases including Leber congenital amaurosis (LCA), bestrophinopathy, and retinitis pigmentosa. Its lead gene therapy candidates are OPGx-LCA5, which is in an ongoing Phase 1/2 trial for LCA5-related mutations, and OPGx-BEST1, a gene therapy targeting BEST1-related retinal degeneration. Opus Genetics is also advancing Phentolamine Ophthalmic Solution
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, expectations regarding us, our business prospects and our results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading “Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025, and our other filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “aim,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise.
Contacts:
Investors
Jenny Kobin
Remy Bernarda
IR Advisory Solutions
ir@opusgtx.com
Media
Kimberly Ha
KKH Advisors
917-291-5744
kimberly.ha@kkhadvisors.com
Source: Opus Genetics, Inc.
FAQ
What is the purpose of Opus Genetics' LYNX-3 Phase 3 trial for Phentolamine Ophthalmic Solution?
What were the results of Opus Genetics' LYNX-2 Phase 3 trial for Phentolamine?
How does Phentolamine Ophthalmic Solution 0.75% work for night vision problems?
What regulatory designations has Opus Genetics received for Phentolamine?
What conditions can Phentolamine Ophthalmic Solution potentially treat?
