{"id":1011038,"date":"2026-10-16T12:08:34","date_gmt":"2026-10-16T16:08:34","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/opus-genetics-announces-fda-approval-of-phentolamine-ophthalmic-solution-0-75-for-the-treatment-of-presbyopia\/"},"modified":"2026-10-16T12:08:34","modified_gmt":"2026-10-16T16:08:34","slug":"opus-genetics-announces-fda-approval-of-phentolamine-ophthalmic-solution-0-75-for-the-treatment-of-presbyopia","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/opus-genetics-announces-fda-approval-of-phentolamine-ophthalmic-solution-0-75-for-the-treatment-of-presbyopia\/","title":{"rendered":"Opus Genetics Announces FDA Approval of Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia"},"content":{"rendered":"
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\n FDA expands the approved use of phentolamine ophthalmic solution 0.75% to include age-related near vision impairment, which affects millions of adults in the United States<\/em>\n <\/p>\n

\n Approval supported by positive results from pivotal Phase 3 VEGA-2 and VEGA-3 trials, which met primary and all key secondary efficacy endpoints<\/em>\n <\/p>\n

RESEARCH TRIANGLE PARK, N.C., Oct. 16, 2026 (GLOBE NEWSWIRE) — Opus Genetics, Inc<\/a>. (Nasdaq: IRD) (\u201cOpus Genetics\u201d or the \u201cCompany\u201d), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs),\u00a0today announced that the U.S. Food and Drug Administration (FDA) has approved the Company\u2019s supplemental New Drug Application (sNDA) for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia in adults.<\/p>\n

Opus Genetics and\u00a0Viatris\u00a0Inc. (through an affiliated entity) are parties to a global licensing agreement which provides for the development of phentolamine ophthalmic solution 0.75%\u00a0and grants exclusive rights to\u00a0Viatris\u00a0to commercialize the product in the\u00a0United States.<\/p>\n

This FDA approval in presbyopia will trigger a milestone payment to Opus Genetics.<\/p>\n

Presbyopia is an age-related condition that affects the ability to focus on near objects, often requiring reading glasses or other corrective lenses. The condition affects approximately 90% of adults in the United States over the age of 45. Phentolamine ophthalmic solution 0.75% offers a non-invasive, pharmacologic treatment option designed to improve near vision while preserving distance vision.<\/p>\n

\u201cThis approval marks an important milestone for Opus Genetics, representing our second U.S. drug approval and underscoring our clinical and regulatory capabilities,\u201d said George Magrath, M.D., Chief Executive Officer, Opus Genetics. \u201cIt reinforces our commitment to advancing innovative ophthalmic therapies that address unmet patient needs. We are grateful to the patients, investigators and clinical sites who contributed to this achievement, and we look forward to working closely with our commercial partner to bring RYZUMVI\u00ae<\/sup> to patients.\u201d<\/p>\n

The FDA approval is supported by positive results from the pivotal Phase 3 VEGA-2 and VEGA-3 clinical trials, both of which met their primary and all key secondary efficacy endpoints, with no treatment-related serious adverse events reported. Phentolamine ophthalmic solution 0.75% is a preservative-free, topical formulation that reduces pupil diameter through a sympatholytic mechanism of action, without engaging the ciliary muscle.<\/p>\n

Phentolamine ophthalmic solution 0.75% is marketed in the United States as RYZUMVI\u00ae<\/sup> for the treatment of pharmacologically induced mydriasis. The supplemental approval expands its approved indications to include presbyopia in adults.<\/p>\n

\n INDICATIONS AND USAGE<\/strong>\n <\/p>\n

RYZUMVI\u00ae<\/sup>\u00a0(phentolamine ophthalmic solution) 0.75% is indicated for:<\/p>\n