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Opus Genetics Announces LYNX-2 Phase 3 Trial Met its Primary Endpoint for Phentolamine Ophthalmic Solution 0.75% in Keratorefractive Patients with Visual Disturbances Under Mesopic, Low-Contrast Conditions

1. Opus Genetics announced positive Phase 3 results for Phentolamine Ophthalmic Solution. 2. 17.3% of patients achieved significant vision improvement after 15 days of treatment. 3. Phentolamine targets chronic night driving impairment with no current FDA-approved therapies. 4. Study safety profile mirrors previous trials, showing no new safety signals. 5. FDA granted Fast Track designation for Phentolamine's treatment of specific vision disturbances.

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Why Very Bullish?

The successful Phase 3 results for a unique treatment and FDA Fast Track status could significantly enhance IRD's market perception. Historical examples show that successful trial results often lead to bullish price movements for biotech firms, as seen with companies like Vertex Pharmaceuticals post-Phase 3 trials.

How important is it?

The article highlights a critical milestone in IRD's product development, addressing significant unmet needs in a niche market, which is likely to attract investor interest and speculation.

Why Short Term?

The immediate positive trial results and Fast Track status are likely to influence stock price quickly, often seen within weeks of such announcements, similar to the rapid impacts seen after catalysts like FDA approvals or strong clinical trial results.

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June 02, 2025 08:00 ET  | Source: Opus Genetics, Inc. Study met primary endpoint of ≥15-letter (≥3-line) gain in mesopic low contrast distance visual acuity in comparison to placeboPhase 3 study showed patient-reported functional benefit in treating significant, chronic night driving impairment in keratorefractive patients with reduced mesopic vision, a condition with no current FDA-approved therapiesSafety profile consistent with previous studies, with no new safety signals identified No evidence of tachyphylaxis was observed in this study over the 6-week periodStudy was conducted under FDA Special Protocol Assessment and Fast-Track Designation RESEARCH TRIANGLE PARK, N.C., June 02, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage biopharmaceutical company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders, today announced positive topline results from LYNX-2, a pivotal Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75% for the treatment of significant, chronic night driving impairment in keratorefractive patients with reduced mesopic vision. Patients who undergo keratorefractive procedures such as Laser-Assisted In Situ Keratomileusis (LASIK), Photorefractive Keratectomy (PRK), Small-Incision Lenticule Extraction (SMILE) and Radial Keratotomy (RK), often experience vision disturbances including glare, halos and starbursts, due to increased optical aberrations and light scatter under low-light (mesopic), low-contrast conditions. These disturbances can significantly impair night driving and daily functioning in dim environments. Phentolamine Ophthalmic Solution 0.75% is designed to reduce pupil diameter through a sympatholytic mechanism of action that avoids engaging the ciliary muscle, potentially reducing risks such as retinal tears or detachment associated with older parasympathomimetic agents. The LYNX-2 study met its primary endpoint of a gain of three lines (or 15 letters) or more of distance vision improvement on a low contrast chart in low light conditions after 15 days of dosing. In the study, 17.3% of patients treated with Phentolamine Ophthalmic Solution 0.75% achieved a ≥15-letter Early Treatment Diabetic Retinopathy Study (ETDRS) (≥ 3-line) improvement in Mesopic Low Contrast Distance Visual Acuity (mLCVA) at Day 15, compared to 9.2% in the placebo group (p<0.05). “In LYNX-2, Phentolamine Ophthalmic Solution 0.75% delivered a statistically significant primary endpoint. In addition, patient-reported outcome results demonstrated improvements in night-driving vision, enabling patients to function more effectively in low-light, low-contrast conditions,” said George Magrath, MD, CEO, Opus Genetics. “This data builds on earlier results from the LYNX-1 trial and provides evidence of efficacy for this condition, which currently has no FDA-approved therapies. We believe this therapy could address a true unmet need and could offer meaningful benefits to keratorefractive patients experiencing glare, halos, and reduced functional vision in low-light, low-contrast environments.” “The positive results from the LYNX-2 trial reinforce the potential of Phentolamine Ophthalmic Solution 0.75% as a first-in-class treatment for keratorefractive patients with vison disturbances under low-light conditions,” said Jay Pepose, MD, PhD, Chief Medical Advisor, Opus Genetics. “After just 15 days of treatment, 17% of patients with dysphotopsia following keratorefractive surgery achieved at least 15-letter gain in mesopic low contrast distance vision. Importantly, we also saw functional improvements in difficulty of seeing the road because of oncoming headlights; and difficulty seeing due to glare when driving at dawn or dusk, as reported by patients in the trial.” LYNX-2 Phase 3 Study LYNX-2 was a randomized, double-masked, placebo-controlled Phase 3 trial evaluating the safety and efficacy of Phentolamine Ophthalmic Solution 0.75% in 199 patients who had previously undergone keratorefractive surgery and reported decreased visual acuity under mesopic low contrast conditions, and who were randomized to receive either Phentolamine or placebo, self-administered in both eyes, nightly, treated and observed over 6 weeks. The mITT Population includes all randomized patients who received at least one dose of study medication and was used for the primary endpoint analysis and to analyze efficacy endpoints. The trial was conducted under a Special Protocol Assessment (SPA) agreement with the U.S. FDA. Top-Line Results: The primary endpoint was defined as the percentage of patients achieving a ≥15-letter ETDRS (≥3-line) improvement in mesopic low contrast distance visual acuity (mLCVA). 17.3% of patients in the Phentolamine arm achieved ≥15-letter ETDRS (≥3-line) gain in mLCVA at Day 15, compared to 9.2% of those receiving placebo (p<0.05). Patient-reported benefit was observed at Day 15 in difficulty of seeing the road because of oncoming headlights and difficulty seeing due to glare when driving at dawn or dusk, in patients taking Phentolamine Ophthalmic Solution 0.75% compared to placebo (p<0.05) when assessed by the validated Vision and Night Driving Questionnaire (VND-Q). As per the pre-specified testing, no evidence of tachyphylaxis out to Week 6 of dosing.1 Phentolamine Ophthalmic Solution 0.75% demonstrated a safety profile consistent with previous trials, with no new safety signal identified. LYNX-2 patients will continue to be monitored for long-term safety over 48 weeks. Additional details on the study design can be found at ClinicalTrials.gov (NCT06349759). Opus Genetics and Viatris (through its affiliate) are parties to a global licensing agreement which provides for the development of Phentolamine Ophthalmic Solution 0.75% and grants exclusive rights to Viatris to commercialize Phentolamine Ophthalmic Solution 0.75% in the U.S. 1 The study is also designed to examine tachyphylaxis of the therapeutic response to Phentolamine Ophthalmic Solution 0.75% for mLCVA. This was to be achieved by comparing change from Baseline at Week 6 in the Phentolamine Ophthalmic Solution 0.75% group to the best change from baseline achieved during the first month of treatment for mLCVA. About Phentolamine Ophthalmic Solution 0.75%Phentolamine Ophthalmic Solution 0.75% is a non-selective alpha-1 and alpha-2 adrenergic antagonist to reduce pupil size. It works by uniquely blocking the alpha-1 receptors found on the radial iris dilator muscles, which are activated by the alpha-1 adrenergic receptors, without affecting the ciliary muscle. Phentolamine Ophthalmic Solution 0.75% is currently being evaluated in two Phase 3 trials programs for the treatment of dim (mesopic) light vision disturbances (sometimes referred to as DLD) after keratorefractive surgery (LYNX clinical program) and presbyopia (VEGA clinical program). The U.S. FDA granted Fast Track designation to Phentolamine Ophthalmic Solution 0.75% for the treatment of significant, chronic night driving impairment with concomitant increased risk of motor vehicle accidents and debilitating loss of best spectacle corrected mesopic vision in keratorefractive patients with photic phenomena (i.e., glare, halos, starburst). About Opus Genetics Opus Genetics is a clinical-stage biopharmaceutical company developing gene and small molecule therapies for vision-threatening eye diseases. The company’s pipeline features AAV-based gene therapies targeting inherited retinal diseases such including Leber congenital amaurosis (LCA), bestrophinopathy, and retinitis pigmentosa. Its lead candidate, OPGx-LCA5, is in a Phase 1/2 trial for LCA5-related mutations and has shown encouraging early results. Additional programs include OPGx-BEST1, a gene therapy targeting BEST1-related retinal degeneration and a Phase 3-ready small molecule therapy for diabetic retinopathy, developed under a Special Protocol Agreement with the FDA. Opus is also advancing Phentolamine Ophthalmic Solution 0.75%, a partnered therapy currently approved in one indication and is being studied in two Phase 3 programs for presbyopia and dim light vision disturbances. The company is based in Research Triangle Park, NC. For more information, visit www.opusgtx.com.  Forward Looking StatementsThis 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 data from our clinical trials. 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 for the fiscal year ended December 31, 2024 and in 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 of this press release. 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 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, including, without limitation: Our clinical data related to gene therapies for the treatment of inherited retinal diseases is preliminary and related to a relatively small group of patients, and, as a result, data that initially appears promising may be revised, updated, or invalidated at a later data readout and/or may ultimately not be capable of duplication in additional patients;Failure to successfully integrate our businesses following our acquisition of former Opus Genetics Inc. (the “Opus Acquisition”) could have a material adverse effect on our business, financial condition and results of operations;The Opus Acquisition significantly expanded our product pipeline and business operations and shifted our business strategies, which may not improve the value of our common stock;Our gene therapy product candidates are based on a novel technology that is difficult to develop and manufacture, which may result in delays and difficulties in obtaining regulatory approval;Our planned clinical trials may face substantial delays, result in failure, or provide inconclusive or adverse results that may not satisfy FDA requirements to further develop our therapeutic products;Delays or difficulties associated with patient enrollment in clinical trials may affect our ability to conduct and complete those clinical trials and obtain necessary regulatory approvals;Changes in regulatory requirements could result in increased costs or delays in development timelines;We depend heavily on the success of our product pipeline; if we fail to find strategic partners or fail to adequately develop or commercialize our pipeline products, our business will be materially harmed;Others may discover, develop, or commercialize products similar to those in our pipeline before or more successfully than we do or develop generic variants of our products even while our product patents remain active, thereby reducing our market share and potential revenue from product sales;We do not currently have any sales or marketing infrastructure in place, and we have limited drug research and discovery capabilities;The future commercial success of our products could significantly depend upon several uncertain factors, including third-party reimbursement practices and the existence of competitors with similar products;Product liability lawsuits against us or our suppliers or manufacturers could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop;Failure to comply with health and safety laws and regulations could lead to material fines;We have not generated significant revenue from sales of any products and expect to incur losses for the foreseeable future;Our future viability is difficult to assess due to our short operating history and our future need for substantial additional capital, access to which could be limited by any adverse developments that affect the financial services markets;Raising additional capital may cause our stockholders to be diluted, among other adverse effects;We operate in a highly regulated industry and face many challenges adapting to sudden changes in legislative reform or the regulatory environment, which affects our pipeline stability and could impair our ability to compete in international markets;We may not receive regulatory approval to market our developed product candidates within or outside of the U.S.;With respect to any of our product candidates that receive marketing approval, we may be subject to substantial penalties if we fail to comply with applicable regulatory requirements;Our potential relationships with healthcare providers and third-party payors will be subject to certain healthcare laws and regulations, which could expose us to extensive potential liabilities;We rely on third parties for material aspects of our business, such as conducting our nonclinical and clinical trials and supplying and manufacturing bulk drug substances, which exposes us to certain risks;We may be unsuccessful in entering into or maintaining licensing arrangements (such as the Viatris License Agreement) or establishing strategic alliances on favorable terms, which could harm our business;Our current focus on the cash-pay utilization for future sales of RYZUMVI may limit our ability to increase sales or achieve profitability with this product;Inadequate patent protection for our product candidates may result in our competitors developing similar or identical products or technology, which would adversely affect our ability to successfully commercialize;We may be unable to obtain full protection for our intellectual property rights under U.S. or foreign laws;We may become involved in lawsuits for a variety of reasons associated with our intellectual property rights, including alleged infringement suits initiated by third parties;We are dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy;As we grow, we may not be able to operate internationally or adequately develop and expand our sales, marketing, distribution, and other corporate functions, which could disrupt our operations;The market price of our common stock is expected to be volatile;Our common stock may be subject to delisting from the Nasdaq Capital Market and delisting could adversely affect our ability to access capital markets;Factors out of our control related to our securities, such as securities litigation or actions of activist stockholders, could adversely affect our business and stock price and cause us to incur significant expenses; andImpact from current or proposed tariffs on imported goods we purchase. 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. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. ContactsInvestors Jenny KobinRemy BernardaIR Advisory Solutionsir@opusgtx.com MediaKimberly HaKKH Advisors917-291-5744kimberly.ha@kkhadvisors.com

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