Opus Genetics has won FDA approval to add presbyopia to the label of RYZUMVI, its phentolamine ophthalmic solution 0.75%, one day ahead of the drug’s 17 October 2026 PDUFA goal date. It is the Research Triangle Park company’s second U.S. drug approval and the second indication for a drop FDA first cleared in September 2023 to reverse the pupil dilation of an eye exam — now approved to treat the blurred near vision of middle age instead.
From mydriasis to presbyopia, one label at a time
RYZUMVI’s two approvals
- September 2023
First FDA approval
NDA 217064: RYZUMVI (phentolamine ophthalmic solution 0.75%) approved to reverse pharmacologically-induced mydriasis — the dilation from an eye exam — under sponsor Ocuphire Pharma.
- 2024
Ocuphire merges with Opus Genetics
Ocuphire Pharma merges with gene-therapy developer Opus Genetics, Inc., taking the Opus Genetics name and adding RYZUMVI to a pipeline of inherited-retinal-disease gene therapies.
- 25 February 2026
sNDA accepted
FDA accepts Opus Genetics’ supplemental New Drug Application seeking a presbyopia indication, setting a 17 October 2026 PDUFA goal date.
- 16 October 2026
Presbyopia indication approved
FDA approves the sNDA a day ahead of its goal date — Opus Genetics’ second U.S. drug approval.
What VEGA-2 and VEGA-3 showed
FDA’s approval rests on two Phase 3 trials, VEGA-2 and VEGA-3, which Opus Genetics says met their primary endpoint and all key secondary endpoints for improving near vision in adults with presbyopia. The most common ocular adverse reactions reported were conjunctival hyperemia (21% of patients) and instillation-site irritation (16%); the label advises against use in patients with active ocular inflammation such as iritis. Unlike pilocarpine-based competitors, which work by constricting the pupil, phentolamine is a non-selective alpha-1 and alpha-2 adrenergic antagonist — it relaxes the iris dilator muscle to reduce pupil diameter without engaging the ciliary muscle that pilocarpine acts on.
“[This is] our second US drug approval, underscoring our clinical and regulatory capabilities.” George Magrath, MD, President and CEO, Opus Genetics — 16 October 2026 announcement, as reported by Ophthalmology Times
RYZUMVI’s second approval in four figures
Figures from Opus Genetics’ and Viatris’ 16 October 2026 announcements, as reported by Ophthalmology Times and Optometry Times.
A relaxed iris instead of a constricted pupil
Presbyopia — the age-related loss of near focus that eventually affects nearly everyone past their mid-forties — has had an FDA-approved eye-drop treatment only since AbbVie’s Vuity (pilocarpine 1.25%) launched in 2021. Pilocarpine drops work by constricting the pupil to a pinhole, extending depth of focus the way a camera’s smaller aperture does. RYZUMVI takes a different mechanism into the same symptom: as a non-selective alpha-1 and alpha-2 adrenergic antagonist, it relaxes the iris dilator muscle rather than contracting the sphincter, a distinction Opus Genetics and Viatris are expected to lean on commercially once a launch date is set.
Three things a second mechanism changes
Alpha-antagonist, not miotic
RYZUMVI relaxes the iris dilator muscle instead of constricting the pupil sphincter — a different mechanism from pilocarpine-based Vuity and Qlosi, the category’s two approved entrants to date.
A drug already on pharmacy shelves
RYZUMVI has carried an FDA-approved indication, a label and a safety record since September 2023; the presbyopia approval extends an existing product rather than launching a new molecule.
A licensing partner already in place
Viatris holds exclusive U.S. commercial rights under a global license agreement signed before this approval, giving RYZUMVI an established pharmaceutical distributor rather than requiring Opus Genetics to build a commercial organization from scratch.
A third drop enters a two-drug aisle
RYZUMVI becomes the third FDA-approved presbyopia eye drop, after AbbVie’s Vuity (2021) and Orasis Pharmaceuticals’ Qlosi (pilocarpine 0.4%, approved 2023 and marketed since spring 2025). S&P Global’s Visible Alpha has projected Vuity revenue of $117 million for 2026, and notes AbbVie has not yet broken the product’s sales out separately in its quarterly filings — a sign that, four years after the category’s launch, no entrant has yet turned presbyopia drops into a reliably disclosed revenue line.
Presbyopia treatment, by two measures
$11.0B → $20.2B
DelveInsight’s 2025 four-market (US, EU4, UK and Japan) presbyopia-treatment estimate, versus Coherent Market Insights’ broader 2025 global presbyopia-treatment total, which includes devices and surgical options alongside drops.
Sources: DelveInsight, Presbyopia Market Insight, Epidemiology and Market Forecast · Coherent Market Insights, Presbyopia Treatment Market, 2025-2032
Regulatory News outlook
We expect eye drops to remain a small slice of the broader presbyopia-treatment total for several more years, with RYZUMVI competing chiefly against Vuity and Qlosi for a drop-category Vuity has not yet disclosed as material revenue.
How we got here: Coherent Market Insights’ $20.2 billion 2025 global figure spans glasses-adjacent options, devices and surgery alongside drops; against that base, Vuity’s own $117 million 2026 forecast (S&P Global Visible Alpha) implies eye drops are low single digits of the total category today, a share we expect to grow only gradually as a third approved drop joins the aisle.
RYZUMVI against the approved presbyopia drops
| Product | Mechanism | Concentration | U.S. approval | Marketer |
|---|---|---|---|---|
| RYZUMVI (Opus Genetics / Viatris) | Alpha-1/alpha-2 adrenergic antagonist (iris relaxant) | 0.75% | October 2026 (presbyopia); Sept. 2023 (mydriasis) | Viatris (exclusive U.S. rights) |
| Vuity (AbbVie) | Miotic (pupil constrictor) | Pilocarpine 1.25% | October 2021 | AbbVie |
| Qlosi (Orasis Pharmaceuticals) | Miotic (pupil constrictor) | Pilocarpine 0.4% | 2023; marketed since spring 2025 | Orasis Pharmaceuticals |
From each company’s own labelling and announcements; not a clinical comparison.
What launch still depends on Viatris
FDA’s approval settles the regulatory question; the commercial one is still open. Viatris’ own 16 October release says it is exploring the potential for a U.S. partner to commercialize RYZUMVI for presbyopia, language that stops short of committing to a launch date, a price or even which organization will ultimately sell the drop. Neither company’s announcement stated a launch timeline or label dosing instructions. For a regulatory reader, the approval is also a reminder that a drug’s first indication rarely tells the whole commercial story: RYZUMVI spent three years on pharmacy shelves for mydriasis reversal, a comparatively low-volume use, before this label expansion gave it a shot at the much larger presbyopia population.
- Launch: no date announced; Viatris says it is still exploring a U.S. commercialization partner for the presbyopia indication specifically.
- Pricing: not disclosed in either company’s announcement.
- Safety: not recommended for patients with active ocular inflammation, such as iritis; conjunctival hyperemia (21%) and instillation-site irritation (16%) were the most common reactions in trials.
- Competitive response: neither AbbVie nor Orasis Pharmaceuticals had publicly responded to the RYZUMVI approval as of this writing.
Sources & further reading
- Opus Genetics, announcement of FDA approval of RYZUMVI for presbyopia, 16 October 2026, as reported by Ophthalmology Times. ophthalmologytimes.com
- Optometry Times, “FDA approves phentolamine ophthalmic solution 0.75% (RYZUMVI) for presbyopia,” 16 October 2026. optometrytimes.com
- Viatris Inc., “Viatris Receives U.S. FDA Approval for RYZUMVI for the Treatment of Presbyopia,” 16 October 2026 (as republished). placera.se
- FDA, Drugs@FDA application overview, NDA 217064 (RYZUMVI). accessdata.fda.gov
- Ophthalmology Times, “SNDA for phentolamine ophthalmic solution 0.75% from Opus Genetics accepted for review by FDA,” 25 February 2026. ophthalmologytimes.com
- S&P Global Market Intelligence, “Analysts see Lenz Vizz exceeding $1 billion in sales by 2038,” presbyopia-category revenue estimates. spglobal.com
- DelveInsight, Presbyopia Market Insight, Epidemiology and Market Forecast. delveinsight.com
- Coherent Market Insights, Presbyopia Treatment Market, 2025-2032. coherentmi.com
Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.
Frequently asked questions
What did FDA approve?
A supplemental New Drug Application adding presbyopia in adults to the label of RYZUMVI (phentolamine ophthalmic solution 0.75%), approved 16 October 2026, one day ahead of its 17 October PDUFA goal date.
Was RYZUMVI already approved for something else?
Yes. FDA first approved it in September 2023 (NDA 217064) to reverse pharmacologically-induced mydriasis — the pupil dilation from an eye exam. The presbyopia approval is a new indication for the same drop.
Who will sell RYZUMVI for presbyopia?
Viatris Inc. (Nasdaq: VTRS) holds exclusive U.S. commercialization rights under a global licensing agreement with Opus Genetics. Viatris has said it is exploring a U.S. commercialization partner; neither company has announced a launch date.
What did the trials show?
Approval rests on the Phase 3 VEGA-2 and VEGA-3 trials, which met their primary and all key secondary endpoints. The most common ocular adverse reactions were conjunctival hyperemia (21%) and instillation-site irritation (16%); the drug is not recommended for patients with active ocular inflammation such as iritis.
