Viatris’ presbyopia drug MR-141 (phentolamine ophthalmic solution 0.75%) has met the primary endpoint and all secondary endpoints in a second Phase III trial.
The VEGA-3 study (NCT06542497) saw significantly more patients treated with MR-141 achieve at least a three-line gain on the Early Treatment Diabetic Retinopathy Study (ETDRS) and less than five letters of loss in binocular best-corrected distance visual acuity (BCDVA).
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Additional patients in the treatment arm also achieved functional benefit at days three and eight, as well as after six weeks, with their near vision upon awakening and satisfaction with their improvement in near vision. There was also noted improvement in near vision in dim and low lighting at the same time intervals.
Regarding safety, there was no evidence of tachyphylaxis during the six-week follow-up, and overall, the drug was well tolerated.
Patients on the VEGA-3 trial will be able to continue the study drug for 48 weeks to further monitor long-term safety.
Viatris’ chief R&D officer Philippe Martin said: “Presbyopia is a very common condition affecting approximately 90% of adults in the US over the age of 45, who often experience blurred near vision and eye strain.
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By GlobalData“We are pleased with the positive results from the second pivotal Phase III 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.”
Based on the data, Viatris is looking to approach the US Food and Drug Administration (FDA) for approval of MR-141 in H2 2025.
Presbyopia is the progressive loss of the ability to focus on close objects, leading to blurred near vision and eye strain, particularly in dim lighting conditions.
There are only two therapies approved for the condition: AbbVie’s Vuity (pilocarpine hydrochloride 1.25%) and Florida-based Orasis Pharmaceuticals’ Qlosi (pilocarpine hydrochloride 0.4%). Last year, Lenz Therapeutics reported a successful Phase III trial of its therapy LNZ100 (aceclidine) and has applied for approval to the FDA with a Prescription Drug User Fee Act (PDUFA) date of 8 August 2025.
Most patients with presbyopia use reading glasses or contact lenses to correct their sight, with experts previously stating that this cheap and accessible standard of care (SoC) will create a barrier for pharmaceutical companies in this space.
