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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:
As per the pre-specified testing, no evidence of tachyphylaxis out to Week 6 of dosing.1
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 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 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:
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.
Contacts
Investors
Jenny Kobin
Remy Bernarda
IR Advisory Solutions
[email protected]
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KKH Advisors
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