Key Takeaways
- MR-141 shows significant efficacy in presbyopia treatment: A total of 27.2% of patients achieved a ≥3-line gain in near visual acuity vs. 11.5% with placebo at 12 hours post-dose.
- Favorable safety and tolerability profile: No serious treatment-related adverse events (AEs) reported; common AEs were mild and included conjunctival hyperemia and instillation site irritation.
- Regulatory path moves forward: Viatris and Opus Genetics plan to submit an FDA application for phentolamine ophthalmic solution 0.75% in the second half of 2025.
Results from the Phase III VEGA-3 trial (NCT06542497) show that significantly more patients treated with Viatris and Opus Genetics’ MR-141 (phentolamine ophthalmic solution 0.75%) for presbyopia achieved a ≥3-line gain in binocular near visual acuity compared to placebo. According to the companies, this improvement was observed both 12 hours after dosing on day eight and one hour after dosing on day one, without compromising distance vision.1
How Effective and Safe Is MR-141 for Treating Presbyopia?
"Presbyopia is a very common condition affecting approximately 90 percent of adults in the US over the age of 45, who often experience blurred near vision and eye strain,” said Philippe Martin, chief R&D officer, Viatris, in a press release. “We are pleased with the positive results from the second pivotal Phase 3 trial, which reinforce our confidence in MR-141 and its benefit-risk profile as a potential, non-invasive option to support the millions of patients impacted by this condition."
VEGA-3 Trial Design
- The randomized, double-blind, placebo-controlled VEGA-3 trial evaluated the safety and efficacy of MR-141 in 545 patients.
- Patients were randomly assigned in a 3:2 ratio to receive either MR-141 or placebo once daily in the evening.
- The primary endpoint of the trial was the percentage of patients with ≥ 15 letters of improvement in binocular distance-corrected near visual acuity (DCNVA) and with < 5 letters of loss in binocular best-corrected distance visual acuity (BCDVA) from baseline at 12 hours post-dose at day eight.1,2
Efficacy Outcomes and Safety Profile
- Results showed that 27.2% of patients treated with MR-141 achieved a ≥15-letter improvement in binocular DCNVA, with less than a five-letter loss in binocular BCDVA at 12 hours post-dose on day eight. In the placebo group, only 11.5% achieved the same.
- MR-141 also demonstrated consistent patient-reported improvements in near vision function, particularly in dim lighting, as early as day three and continued through day six, with no signs of tachyphylaxis.
- The safety profile of MR-141 was reported to be consistent with previous trials, with no new safety signals or serious treatment-related adverse events (TEAEs) identified.
- The most common TEAEs included conjunctival hyperemia, instillation site irritation, and dysgeusia.1,3
Licensing Background and Market Context
In November 2022, Opus (then Ocuphire Pharma) entered an exclusive license agreement with FamyGen Life Sciences—later acquired by Viatris—to develop and commercialize Nyxol eye drops for presbyopia, as well as for mydriasis and night vision disturbances.4,5
According to the American Optometric Association, 90% of people aged 45 years and older in the United States are affected by presbyopia.6 The Cleveland Clinic estimates there will be approximately 2.1 billion cases of presbyopia by 2030, up from 1.8 billion in 2015.7
Next Steps Toward FDA Submission
“The results of the VEGA-3 trial reinforce our belief that Phentolamine Ophthalmic Solution 0.75% could offer an option to improve near vision for millions of adults affected by presbyopia,” said George Magrath, MD, CEO, Opus Genetics, in a press release. “The positive results from both our Phase 3 VEGA-2 and VEGA-3 trials support the submission of an application to the US FDA, which we plan to file in the second half of 2025. I want to thank the participants and clinical teams who participated in VEGA-3 and who have helped us bring Phentolamine Ophthalmic Solution 0.75% to this point in development.”
References
- Viatris Announces Positive Top-Line Results from Second Pivotal Phase 3 VEGA-3 Trial of MR-141 in Presbyopia. Viatris. June 26, 2025. Accessed July 1, 2025. https://newsroom.viatris.com/2025-06-26-Viatris-Announces-Positive-Top-Line-Results-from-Second-Pivotal-Phase-3-VEGA-3-Trial-of-MR-141-in-Presbyopia
- Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia (VEGA-3). Clinicaltrials.gov. Accessed July 1, 2025. https://www.clinicaltrials.gov/study/NCT06542497?term=NCT06542497&rank=1
- Opus Genetics Announces VEGA-3 Phase 3 Trial Met its Primary Endpoint for Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia. Globe Newswire. June 26, 2025. Accessed July 1, 2025. https://www.globenewswire.com/news-release/2025/06/26/3105692/0/en/Opus-Genetics-Announces-VEGA-3-Phase-3-Trial-Met-its-Primary-Endpoint-for-Phentolamine-Ophthalmic-Solution-0-75-for-the-Treatment-of-Presbyopia.html?utm_source=chatgpt.com
- Ocuphire Pharma Enters into a Global License Agreement for Development and Commercialization of Nyxol Eye Drops for Reversal of Mydriasis, Presbyopia and Night Vision Disturbances. GlobeNewswire. November 7, 2022. Accessed July 1, 2025. https://www.globenewswire.com/news-release/2022/11/07/2550236/0/en/Ocuphire-Pharma-Enters-into-a-Global-License-Agreement-for-Development-and-Commercialization-of-Nyxol-Eye-Drops-for-Reversal-of-Mydriasis-Presbyopia-and-Night-Vision-Disturbances.html?utm_source=chatgpt.com
- Viatris Announces Two Acquisitions to Create What it Expects to be a Leading Ophthalmology Franchise; Plans to Provide Strategic Update on its February 2022 Investor Event. Viatris. November 7, 2022. Accessed July 1, 2025. https://investor.viatris.com/news-releases/news-release-details/viatris-announces-two-acquisitions-create-what-it-expects-be
- For 128 million U.S. presbyopes, doctors of optometry can provide treatment options. AOA. August 24, 2023. Accessed July 1, 2025. https://www.aoa.org/news/clinical-eye-care/diseases-and-conditions/for-128-million-us-presbyopes-doctors-of-optometry-can-provide-treatment-options
- Presbyopia. Cleveland Clinic. Accessed July 1, 2025. https://my.clevelandclinic.org/health/diseases/8577-presbyopia
