First Patient Enrolled in LYNX-2 Phase 3 Study Evaluating Phentolamine Ophthalmic Solution 0.75% (PS) for the Treatment of Decreased Visual Acuity Under Low Light Conditions Following Keratorefractive Surgery
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Insights
The initiation of Ocuphire Pharma's LYNX-2 Phase 3 registration study is a pivotal moment for the company, as it marks the progression of a potentially marketable treatment for visual disturbances post-keratorefractive surgery. The relevance of this study, backed by a Special Protocol Assessment (SPA) with the FDA, signifies a strong vote of confidence in the trial's design and potential for regulatory approval. The biopharmaceutical industry is highly competitive and the success of such a trial could provide a significant competitive edge to Ocuphire.
As there are currently no FDA-approved treatments for decreased visual acuity under low light conditions, the approval of Phentolamine Ophthalmic Solution (PS) could meet a substantial unmet medical need. This could result in a sizeable market opportunity, as keratorefractive surgeries like LASIK are common. Investors should monitor the trial's progress closely, as positive outcomes could lead to a surge in Ocuphire's stock value due to the anticipation of new revenue streams from PS.
From a medical standpoint, the development of Phentolamine Ophthalmic Solution 0.75% represents an innovative approach to addressing post-surgical visual disturbances, a common complication of keratorefractive surgery. The mechanism of action for PS, which involves moderate pupil constriction without engaging the ciliary muscle, could offer a safer alternative to existing treatments that carry risks of retinal tears or detachment.
The previous Phase 3 study, LYNX-1, showed a statistically significant improvement in visual acuity under low light conditions, which is promising for the LYNX-2 study. The preservative-free formulation of PS is also noteworthy, as it aligns with the current trend towards minimizing ocular surface damage and other side effects associated with preservatives in eye drops.
Understanding the market potential for Ocuphire's PS is vital for investors. The target demographic includes not only patients who have undergone LASIK and other keratorefractive surgeries but also extends to those with conditions such as night myopia and post-multifocal IOL implantation. Given the prevalence of these conditions, the addressable market could be substantial. Additionally, the partnership with Viatris could facilitate the commercialization process and enhance market penetration upon approval.
However, it's important to consider the risks involved in biopharmaceutical development. The success of the LYNX-2 study is not guaranteed and any setbacks could impact Ocuphire's financial position and stock price. Furthermore, the adoption rate of new medical treatments can be influenced by factors such as insurance coverage, healthcare provider endorsement and patient awareness, which are all elements that could affect the commercial success of PS.
LYNX-2 Follows SPA Agreement with FDA
Development of PS is Funded by Ocuphire’s Partner Viatris
FARMINGTON HILLS, Mich., April 11, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders, today announced the enrollment of the first subject in the LYNX-2 Phase 3 registration study evaluating Phentolamine Ophthalmic Solution
The LYNX-2 trial is being conducted under conditions of a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). As previously announced, Ocuphire received written agreement from the FDA that the clinical trial protocol and planned statistical analysis of the LYNX-2 Phase 3 trial would adequately address objectives supporting regulatory submission and a potential future marketing application in this indication.
“We are pleased to begin enrollment in the LYNX-2 study of PS,” said George Magrath, M.D., M.B.A., M.S., CEO of Ocuphire. “If our registration program meets expectations, and PS is subsequently approved by the FDA, it could potentially be the first commercial treatment for patients who have undergone LASIK surgery and experience low light visual disturbances. We believe that PS is a product with broad potential applications in ophthalmology. Having already received approval for RYZUMVI™ to treat pharmacologically-induced mydriasis, our partner Viatris, Inc. (Viatris) now has the opportunity to create further value as it pursues additional indications for PS, which also include presbyopia.”
Vision disturbances under low light conditions are characterized by peripheral corneal imperfections (aberrations) that result in unfocused light when the pupil dilates under low light conditions. Patients experience decreased low contrast visual acuity as well as glare, halos and starbursts. Patients undergoing keratorefractive surgery (including LASIK, PRK, SMILE, and RK) have been identified as one of the major sub-populations affected, the others being those who have night myopia (naturally occurring), non-central cortical cataracts, keratoconus or post-multifocal or extended depth of focus intraocular lens (IOL) implantation.
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, PS eye drops have the potential to be a treatment option that could improve patients’ ability to see and function in low light. The previous LYNX-1 Phase 3 study evaluating PS successfully met its primary endpoint, with
Jay Pepose, M.D., PhD., Chief Medical Advisor at Ocuphire, commented, “Low light vision disturbances are characterized by difficulty in distinguishing objects with subtle differences in contrast, such as a pedestrian in a crosswalk at dusk or on a rainy day under low light conditions. This represents a significant, yet often overlooked sequela of LASIK or other forms of keratorefractive surgery. Despite the success and popularity of LASIK for vision correction, a subset of patients find themselves grappling with these low light or night-time vision challenges, for which there has been no specific, targeted treatment available. If approved, PS offers the potential to enhance visual performance in low light conditions and restore a sense of normalcy and confidence in these patients.”
Ocuphire has a global license agreement with Viatris to co-develop and commercialize PS for the reversal of mydriasis, presbyopia and low light vision disturbances. Under the terms of this agreement, the two companies agreed to co-develop the product for each of these conditions, with Viatris providing funding for development of these programs. Further, Ocuphire is eligible to receive specified regulatory or net sales milestone payments associated with these indications as well as royalties on commercial sales. In September 2023, Ocuphire met the
LYNX-2 Design
LYNX-2 is a randomized, double-masked, placebo-controlled Phase 3 registration study designed to evaluate the safety and efficacy of PS compared to placebo in subjects who underwent keratorefractive surgery and then reported decreased visual acuity under low light conditions. The trial is expected to enroll 200 subjects. The primary endpoint, agreed with the FDA under the SPA, will be a gain of 3 lines (or 15 letters) or more of distance vision improvement on a low contrast chart in low light conditions after 15 days of dosing. Additional information about the Phase 3 trial can be found at www.clinicaltrials.gov.
About Ocuphire Pharma
Ocuphire is a clinical-stage ophthalmic biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders.
Ocuphire’s lead retinal product candidate, APX3330, is an oral small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein) for the treatment of non-proliferative diabetic retinopathy (NPDR). Ref-1 is a regulator of the transcription factors HIF-1α and NF-κB. Inhibiting REF-1 reduces levels of vascular endothelial growth factor (VEGF) and inflammatory cytokines which are known to play key roles in ocular angiogenesis and inflammation. APX3330 is an oral tablet to be administered twice per day for the treatment of diabetic retinopathy (DR). A Phase 2 study in subjects with DR and an End-of-Phase 2 meeting have recently been completed, and a SPA is planned to be submitted.
In addition, Ocuphire has a partnership with Viatris to develop and commercialize Phentolamine Ophthalmic Solution
Ocuphire is also developing APX2009 and APX2014, second-generation analogs of APX3330. These programs are being evaluated for treating other retinal diseases such as age-related macular degeneration and geographic atrophy. For more information, please visit www.ocuphire.com.
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 applications of PS in ophthalmology, the registration program for PS, the LYNX-2 Phase 3 registration study, the benefits, uses and side effects of PS treatment, ongoing discussions with the FDA regarding various of our drug products, and continued drug development under our agreement with Viatris.
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,” “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 with Viatris, or our 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 SEC 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 |
| George Magrath, M.D., M.B.A., M.S. CEO ir@ocuphire.com | Corey Davis, Ph.D. LifeSci Advisors cdavis@lifesciadvisors.com |
FAQ
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