Ocuphire Pharma Initiates VEGA-3 Phase 3 Trial Evaluating Phentolamine Ophthalmic Solution 0.75% for Presbyopia
Ocuphire Pharma (Nasdaq: OCUP) has initiated the VEGA-3 Phase 3 trial for Phentolamine Ophthalmic Solution 0.75% to treat presbyopia. The study involves 545 participants and aims to demonstrate a 15-letter improvement in near vision acuity. Top-line data is expected in the first half of 2025.
Additionally, the company's LYNX-2 Phase 3 trial, evaluating the same solution for visual disturbances after keratorefractive surgery, is ongoing with top-line data expected in Q1 2025. This trial, conducted under a Special Protocol Assessment with the FDA, targets a 3-line improvement in low-contrast vision under low light conditions.
Ocuphire Pharma (Nasdaq: OCUP) ha avviato il trial di fase 3 VEGA-3 per la soluzione oftalmica di Fentolamina allo 0,75% per trattare la presbiopia. Lo studio coinvolge 545 partecipanti e mira a dimostrare un miglioramento di 15 lettere nell'acuità visiva da vicino. I risultati preliminari sono attesi per il primo semestre del 2025.
In aggiunta, il trial di fase 3 LYNX-2 dell'azienda, che valuta la stessa soluzione per disturbi visivi dopo la chirurgia cheratorefrattiva, è in corso con i risultati preliminari previsti per il Q1 2025. Questo trial, condotto sotto una Valutazione del Protocollo Speciale con la FDA, ha come obiettivo un miglioramento di 3 righe nella visione a basso contrasto in condizioni di bassa luminosità.
Ocuphire Pharma (Nasdaq: OCUP) ha iniciado el estudio de fase 3 VEGA-3 para la solución oftálmica de Fentolamina al 0,75% para tratar la presbicia. El estudio involucra a 545 participantes y tiene como objetivo demostrar una mejora de 15 letras en la agudeza visual de cerca. Se esperan datos preliminares en la primera mitad de 2025.
Adicionalmente, el estudio de fase 3 LYNX-2 de la compañía, que evalúa la misma solución para disturbios visuales después de la cirugía queratorefractiva, está en curso y se esperan datos preliminares en Q1 2025. Este estudio, realizado bajo una Evaluación de Protocolo Especial con la FDA, tiene como objetivo una mejora de 3 líneas en la visión de bajo contraste en condiciones de poca luz.
Ocuphire Pharma (Nasdaq: OCUP)는 VEGA-3 3상 시험을 시작했습니다. 이 시험은 0.75% 펜톨라민 안과 솔루션을 사용하여 노안을 치료하는 것입니다. 이 연구에는 545명의 참가자가 참여하며, 가까운 시력의 개선을 15자 이상 입증하는 것을 목표로 하고 있습니다. 주요 데이터는 2025년 상반기에 발표될 예정입니다.
또한, 이 회사의 LYNX-2 3상 시험은 각막 굴절 수술 후 시각적 장애를 평가하기 위해 진행 중이며 주요 데이터는 2025년 1분기에 발표될 예정입니다. 이 시험은 FDA와 특별 프로토콜 평가에 따라 진행되며, 저조도 조건에서 저대비 시력의 개선을 3줄 목표로 하고 있습니다.
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Ocuphire Pharma (Nasdaq: OCUP) hat die VEGA-3 Phase 3 Studie für die Augenlösung Phentolamin 0,75% zur Behandlung der Presbyopie gestartet. Die Studie umfasst 545 Teilnehmer und zielt darauf ab, eine Verbesserung der Nahsicht um 15 Buchstaben nachzuweisen. Die vorläufigen Ergebnisse werden im ersten Halbjahr 2025 erwartet.
Darüber hinaus läuft die LYNX-2 Phase 3 Studie des Unternehmens, die dieselbe Lösung zur Bewertung visueller Störungen nach der keratorefraktiven Chirurgie untersucht, und die vorläufigen Ergebnisse werden im Q1 2025 erwartet. Diese Studie wird unter einer speziellen Protokollbewertung mit der FDA durchgeführt und zielt auf eine Verbesserung der Sicht um 3 Zeilen bei niedrigen Kontrastwerten unter schwachen Lichtbedingungen.
- Initiation of VEGA-3 Phase 3 trial for presbyopia treatment
- Ongoing LYNX-2 Phase 3 trial with FDA Special Protocol Assessment
- Potential for first FDA-approved treatment for post-keratorefractive surgery visual disturbances
- Partner agreement to reimburse development costs through FDA approval
- Top-line data for both trials not expected until 2025
- No current FDA-approved treatments in target indications, indicating potential regulatory challenges
Insights
The initiation of Ocuphire Pharma's VEGA-3 Phase 3 trial for Phentolamine Ophthalmic Solution 0.75% marks a significant milestone in presbyopia treatment research. This study, involving 545 participants, aims to provide a non-invasive alternative to traditional corrective measures. The primary endpoint of 15-letter improvement in photopic binocular distance-corrected near visual acuity is ambitious but aligns with clinical relevance. The 48-week follow-up for chronic safety data is important for long-term efficacy assessment. Concurrently, the LYNX-2 Phase 3 trial, conducted under a Special Protocol Assessment, targets a unique patient population with post-keratorefractive surgery visual disturbances. This dual-pronged approach could potentially address two distinct unmet needs in ophthalmology, positioning Ocuphire favorably in the eye care market.
Ocuphire Pharma's advancement to Phase 3 trials for both VEGA-3 and LYNX-2 studies represents a significant value driver for the company. The expected top-line data in Q1 2025 for LYNX-2 and H1 2025 for VEGA-3 provides clear catalysts for potential stock movement. Importantly, the company's partnership agreement for cost reimbursement and sharing demonstrates prudent financial management, potentially preserving cash runway. The addressable market for presbyopia is substantial, affecting nearly everyone over 40, while the post-keratorefractive surgery market, though smaller, lacks FDA-approved treatments, offering a unique market opportunity. Investors should monitor enrollment rates and any interim updates, as these could impact the timeline to potential commercialization and subsequent revenue generation.
Ocuphire's focus on presbyopia and post-keratorefractive surgery visual disturbances targets large, underserved markets. Presbyopia affects an estimated 1.8 billion people globally, with no FDA-approved pharmacological treatments, representing a substantial opportunity. The novel approach of using Phentolamine Ophthalmic Solution 0.75% as a non-invasive, convenient alternative could disrupt the current reliance on reading glasses and bifocals. Moreover, addressing visual disturbances post-keratorefractive surgery fills a niche but critical gap in ophthalmic care. If successful, Ocuphire could capture a significant portion of these markets, potentially reshaping patient care in ophthalmology. The company's dual-pronged strategy mitigates risk by diversifying its product pipeline while targeting related ophthalmic conditions.
Top-line data from VEGA-3 Phase 3 trial expected in first half of 2025
Top-line data from LYNX-2 Phase 3 trial in patients with decreased visual acuity under low light conditions following keratorefractive surgery expected in first quarter of 2025
FARMINGTON HILLS, Mich., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of patients with retinal and refractive eye disorders, today announced that the VEGA-3 Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution
Presbyopia, the gradual loss of ability to focus on near objects, typically becomes noticeable in the early to mid-40s. This progressive and ubiquitous condition leads to the widespread use of reading glasses or bifocals. Phentolamine Ophthalmic Solution
“Our goal is to provide a safe, long-lasting, effective solution that restores near vision and enhances overall visual performance in people with presbyopia, under both daytime and nighttime conditions,” said George Magrath, M.D., M.B.A., M.S., Ocuphire’s Chief Executive Officer. “We are pleased to begin the VEGA-3 trial, building on the positive results generated in our prior presbyopia studies, which have shown a rapid onset of action, favorable safety profile, and sustained duration of effect that are promising at this stage.”
Ocuphire anticipates using data obtained from the VEGA-3 trial demonstrating the efficacy and safety of Phentolamine Ophthalmic Solution
Dr. Magrat continued, “We are also excited about the continued enrollment in the LYNX-2 trial. Our top-line data for LYNX-2 are expected in the first quarter of 2025, assuming enrollment continues at the current rate. I’m very proud of the work our team and partners have put into the execution of this study.”
VEGA-3 Phase 3 Pivotal Trial Design
VEGA-3 is a randomized, double-masked, placebo-controlled, multi-center, Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution
Top Line Data from LYNX-2 Phase 3 Study Expected Q1 2025
The LYNX-2 Phase 3 trial is a randomized, double-masked, placebo-controlled Phase 3 registration trial designed to evaluate the safety and efficacy of Phentolamine Ophthalmic Solution
There are currently no FDA-approved treatments for visual disturbances under low light conditions. With a mechanism of action that moderately reduces pupil size without the increased risks of retinal tears or detachment associated with parasympathomimetic miotics that engage the ciliary muscle, Phentolamine Ophthalmic Solution
Ocuphire is responsible for managing the VEGA-3 and LYNX-2 trials. Under the terms of the License Agreement, Ocuphire’s partner will reimburse Ocuphire for agreed-to budgeted costs related to the development of Phentolamine Ophthalmic Solution
About Phentolamine Ophthalmic Solution
Phentolamine Ophthalmic Solution
About Presbyopia
As the eye ages, the ability to focus for reading and other tasks that require clear vision at near distances decreases. Presbyopia patients experience blurred near vision, difficulty seeing in dim light and eye strain. It is estimated that 128 million Americans, and over 2 billion people worldwide, have presbyopia, and this number is expected to grow as the population ages.
About Dim Light Disturbances after Keratorefractive Surgery
Decreased visual acuity under low light conditions (“DLD”) is characterized by peripheral corneal imperfections (aberrations) that result in unfocused light when the pupil dilates under low light conditions. Patients with DLD experience decreased low contrast visual acuity as well as glare, halos, and starbursts.
About Ocuphire Pharma
Ocuphire Pharma, Inc. (Nasdaq: OCUP) is a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing novel therapies for the treatment of patients with retinal and refractive eye disorders. Ocuphire’s lead product candidate, APX3330, a novel small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein), is in development for diabetic retinopathy. In addition, Ocuphire’s late-stage product candidate 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, statements concerning the efficacy and safety of Phentolamine Ophthalmic Solution
These forward-looking statements relate to 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. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this report. 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.
These forward-looking statements are based upon Ocuphire’s 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, including, without limitation:
- The success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts;
- Regulatory requirements or developments;
- Changes to or unanticipated events in connection with clinical trial designs and regulatory pathways;
- Delays or difficulties in the enrollment of patients in clinical trials;
- Substantial competition and rapid technological change;
- Our development of sales and marketing infrastructure;
- Future revenue losses and profitability;
- Our relatively short operating history;
- Changes in capital resource requirements;
- Risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs;
- Domestic and worldwide legislative, regulatory, political and economic developments;
- Employee misconduct;
- Changes in market opportunities and acceptance;
- Reliance on third parties;
- Future, potential product liability and securities litigation;
- System failures, unplanned events, or cyber incidents;
- The substantial number of shares subject to potential issuance associated with our equity line of credit arrangement;
- Risks that our partnership or other licensing arrangements, may not facilitate the commercialization or market acceptance of Ocuphire’s product candidates;
- Future fluctuations in the market price of our common stock;
- The success and timing of commercialization of any of Ocuphire’s product candidates; and
- Obtaining and maintaining Ocuphire’s intellectual property rights.
The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive. Readers are urged to carefully review and consider the various disclosures made by us in this report and in our other reports filed with the Securities and Exchange Commission that advise interested parties of the risks and factors that may affect our business. All forward-looking statements contained in this press release speak only as of the date on which they were made. Ocuphire undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Contacts
| Corporate | Investor Relations |
| Nirav Jhaveri M.B.A. CFO ir@ocuphire.com | Corey Davis, Ph.D. LifeSci Advisors cdavis@lifesciadvisors.com |
FAQ
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