U.S. Approves Ryzumvi 0.75% for Presbyopia in Adults
Key Facts
Viatris announced that the U.S. Food and Drug Administration approved Ryzumvi, phentolamine ophthalmic solution 0.75%, to treat presbyopia in adults, expanding the use of a product previously marketed to reverse drug-induced pupil dilation. The company announced the regulatory decision in a statement following a review of a supplemental new drug application to add the new indication. The agency had set October 17, 2026 as its target decision date for the application, according to Viatris' statement when it was accepted for review. The approval allows the solution to be used to treat age-related near-vision impairment alongside its previous indication. The decision also has contractual implications for Opus Genetics, with Investing reporting that the approval triggers a milestone payment to the company.
The additional indication targets a condition affecting about 90% of U.S. adults over 45, according to an estimate cited by Viatris when the supplemental application was accepted. The National Eye Institute links blurred near vision to changes in the eye's lens with age. The lens becomes harder and less flexible, reducing its ability to focus light correctly on the retina, according to the institute. Explaining phentolamine's mechanism, Philippe Martin, Viatris' head of research and development, said it can "improve near vision without engaging the ciliary muscle." He added, according to the company's statement, that this mechanism helps preserve distance vision while improving the ability to see up close.
On clinical results, Investing reported that the trials supporting the approval met their primary efficacy endpoints and key secondary endpoints. This included meeting the efficacy measures specified in those trials, according to the website's account of the clinical basis for the regulatory decision. On safety, Viatris said conjunctival hyperemia was among the most common ocular adverse reactions in the presbyopia studies. The reaction was reported in 21% of participants, according to the company's statement on the new indication. The most common reactions also included instillation site irritation, recorded in 16% of participants in the same studies. The approved prescribing information warns against using Ryzumvi in patients with active ocular inflammation, stating that "Ryzumvi is not recommended in patients with active ocular inflammation."
Ryzumvi's earlier regulatory history dates to September 2023, when the FDA approved it for its original indication to treat drug-induced pupil dilation, according to Viatris. The company began marketing it in April 2024, according to an Opus Genetics filing with the U.S. Securities and Exchange Commission. The latest decision thus adds presbyopia treatment to the indications for a product that has already moved from regulatory approval to commercial marketing. In the adult presbyopia treatment market, the U.S. agency had previously approved Vizz from LENZ Therapeutics. The agency's page for the drug lists July 31, 2025 as its approval date and describes it as an aceclidine solution intended to treat the condition in adults.
The commercial relationship between Opus Genetics and Viatris is based on a licensing agreement granting Viatris exclusive rights to market ophthalmic phentolamine in the United States, according to its statement when the supplemental application was accepted. The agreement also provides for tiered royalties to Opus tied to U.S. sales, according to the company's SEC filing. These royalties start in the low double digits and rise to the low end of the 20% range, according to the terms in the filing. Alongside sales-related revenue, the new regulatory approval triggers a contractual milestone payment to Opus, according to Investing. The disclosed arrangements thus combine Viatris' exclusive U.S. marketing rights with Opus' financial rights under the licensing agreement.
As its next commercial step, Viatris said it was exploring a potential U.S. partner to market Ryzumvi for presbyopia. The company described the move in its approval statement as exploring "a potential partner in the United States." The search concerns marketing the new indication in the market where Viatris holds exclusive marketing rights under its agreement with Opus. On its upcoming financial disclosure calendar, Viatris plans to report results for the third quarter of 2026, according to a separate investor statement. The company set November 5, 2026 as the date for releasing those results.