US approval for presbyopia treatment could unlock $10 million for Opus
Key Facts
The US Food and Drug Administration on October 16, 2026, approved expanded use of Ryzumvi, a 0.75% ophthalmic phentolamine solution, to treat presbyopia in adults, according to Viatris. Opus Genetics said the approval triggers a milestone payment under the licensing agreement, while Chardan conference coverage said the expected payment is $10 million during the current quarter. The decision came a day before the October 17 target date set by the agency to rule on the application. The approval adds a new indication for a drug Viatris already markets in the United States. But the company is still exploring the possibility of engaging a US partner to market the product for presbyopia.
The approval was based on two randomized Phase 3 trials, VEGA-2 and VEGA-3, which together enrolled 902 participants aged 40 to 64, according to the drug’s official label. In the VEGA-3 trial, 27.2% of participants who received Ryzumvi achieved an improvement of at least 3 lines in near visual acuity on day 8, compared with 11.5% in the placebo group. The result was recorded 12 hours after the seventh dose, according to the label data. The label recommends one drop in each eye once daily at night for adults. Viatris said the most common ocular adverse reactions among patients with presbyopia were conjunctival hyperemia, reported in 21%, and instillation-site irritation, reported in 16%.
The decision expands the use of a drug that previously received US approval in September 2023 to treat drug-induced mydriasis, and that Viatris began commercially marketing in April 2024, according to an Opus disclosure. The licensing agreement gives Viatris exclusive rights to market the product in the United States, while covering development of the 0.75% phentolamine solution. Viatris said it was "exploring the possibility of contracting with a partner in the United States" to market Ryzumvi for the new indication. Potential milestone payments to Opus under the partnership could total $130 million, according to Chardan conference coverage. The coverage added that the agreement includes royalties beginning in the low double digits and increasing later, without disclosing the precise rates.
The expected payment comes as markets track Opus’s ability to fund its programs. The company disclosed that it had $88.8 million in cash and cash equivalents as of June 30, 2026, and said its cash resources and potential funding under a bond purchase agreement with Oberland Capital could cover operations through 2029. The second-quarter estimate excluded potential proceeds from exercisable warrants and future milestone payments. At the Chardan conference, the chief financial officer said the company had raised about $80 million of announced capital in the second quarter and about $20 million from warrant exercises through the conference, in addition to the expected payment and the possibility of drawing on a credit facility. Management said its cash runway extends through 2029, excluding proceeds from the preferred review coupon.
Second-quarter results reflect continued spending on the company’s programs as its clinical programs advance. Licensing and collaboration revenue was $0.8 million in the quarter ended June 30, 2026, down from $2.9 million in the same period of 2025. Research and development expenses, meanwhile, rose to $11.2 million from $6.0 million. Opus attributed the increase primarily to higher manufacturing and clinical trial costs for inherited retinal disease programs. Among the company’s next milestones, Opus expects to begin dosing in the registrational Phase 3 trial of OPGx-LCA5 during the fourth quarter of 2026, with initial data expected by the end of 2027. The trial includes 8 participants and a 6-month lead-in period before treatment.