FDA Approves Phentolamine Eye Drop for Presbyopia in Adults

The FDA has approved phentolamine ophthalmic solution 0.75% (Ryzumvi; Viatris) for the treatment of presbyopia in adults. The approval gives patients with age-related near vision loss a once-nightly eye drop option, and it gives pharmacists a new set of storage and administration counseling points. The agent was previously indicated only for reversing pharmacologically induced mydriasis, a use for which Viatris says it is the only commercially available FDA-approved product.^1,2

Presbyopia is the gradual, age-related loss of near focusing ability. It typically becomes noticeable in the early to mid-40s and causes eye strain and blurred near vision. According to Viatris, it affects nearly 128 million people in the US, or about 90% of adults older than 45 years.^1,3

How Phentolamine Works

Phentolamine is a relatively nonselective alpha-1 and alpha-2 adrenergic antagonist. According to the prescribing information, it reversibly binds receptors on the iris dilator muscle, which reduces pupil diameter with no effect on the ciliary muscle. Onset generally occurs within 30 minutes, the maximal effect comes at 60 to 90 minutes, and the effect lasts at least 24 hours.^2,4

Initially, it underwent evaluation in the MIRA clinical trial program, which assessed more than 600 participants in various phases, including the phase 2b MIRA-1 trial (NCT04024891), phase 3 MIRA-2 (NCT04620213) and MIRA-3 (NCT05134974) trials, and the phase 3 pediatric MIRA-4 trial (NCT05223478). The solution delivered positive results in the MIRA-2 and MIRA-3 trials by meeting primary and vital secondary goals and confirmed its statistical superiority over a placebo in swiftly restoring dilated pupils to their initial size within 60 and 90 minutes. Equally important, the ophthalmic solution consistently demonstrated safety and tolerability in all trial phases.²

Viatris has framed this mechanism as a way to improve near vision while helping preserve distance vision, because the drug does not engage the ciliary muscle.^2,3

VEGA-2 and VEGA-3 Results

The approval rests on 2 randomized, double-masked, vehicle-controlled phase 3 trials, VEGA-2 (NCT05646719) and VEGA-3 (NCT06542497). Together, the trials randomly assigned 902 adults aged 40 to 64 years. Participants had binocular distance-corrected near visual acuity (DCNVA) of 20/50 to 20/100 and binocular best-corrected distance visual acuity (BCDVA) of 20/25 or better. They instilled 1 drop in both eyes once daily at night.⁴

The primary end point was a gain of at least 3 lines (15 letters) in DCNVA without losing 5 or more letters of BCDVA, assessed 12 hours after the seventh dose. The response rates were⁴:

• VEGA-2: 22.6% with phentolamine vs 11.0% with vehicle (P < .01).
• VEGA-3: 27.2% with phentolamine vs 11.5% with vehicle (P < .01).

The drug separated from the vehicle after the first dose. One hour after dosing on day 1, 13.5% vs 6.1% of patients reached the threshold in VEGA-2, and 20.6% vs 6.1% did in VEGA-3. In VEGA-2, 24% of patients receiving phentolamine versus 15% receiving vehicle achieved a gain of 3 or more lines 20 hours after dosing.⁴

VEGA-3 enrolled 545 participants across 40 US sites. Opus Genetics reported no evidence of tachyphylaxis over 6 weeks and significant patient-reported improvements in satisfaction with near vision upon awakening. No treatment-related serious adverse events (AEs) occurred in the study.⁵

Both trials showed significantly higher response rates than the vehicle. However, most patients in each arm did not reach the 3-line threshold, which pharmacists may want to address when setting expectations.⁴

Safety and Counseling Considerations

Among 534 patients evaluated in the presbyopia trials, the most common ocular AEs were conjunctival hyperemia (21%) and instillation site irritation (16%). The label lists no contraindications. However, use is not recommended in patients with active ocular inflammation, such as iritis, because synechiae may form between the iris and lens. Headache was reported in 2.6% of VEGA-3 participants.^4,5

Several administration details fall to the pharmacy counter⁴:

• Contact lenses: Patients should remove them before instillation and wait 10 minutes before reinserting them.
• Other eye drops: Other topical ophthalmic products should be given at least 5 minutes apart.
• Vials: This phentolamine solution is supplied in preservative-free single-dose vials. One vial can be used for both eyes and should be discarded immediately after use. Patients should avoid touching the tip to the eye or any other surface.
• Storage: Cartons should be refrigerated at 2 °C to 8 °C. Once removed from refrigeration, the drug may be kept at room temperature and used within 35 days.

The presbyopia trials did not include adults aged 65 years or older, so there are no data on whether older patients respond differently.⁴

Commercial Availability Unclear

Viatris holds exclusive US commercialization rights through a global licensing agreement with Opus Genetics. However, Viatris said it is exploring a potential US partner to commercialize Ryzumvi for presbyopia. Neither company announced a launch date or pricing.^1,6

REFERENCES

1. Viatris receives U.S. FDA approval for Ryzumvi for the treatment of presbyopia. News release. Viatris Inc. October 16, 2026. Accessed October 19, 2026. https://newsroom.viatris.com/2026-10-16-Viatris-Receives-U-S-FDA-Approval-for-RYZUMVI-R-for-the-Treatment-of-Presbyopia

2. Azhar A, Riaz R, Khan A, Kumari V, Habib A, Akilimali A. Ryzumvi: pioneering advances in countering drug-induced mydriasis. Ann Med Surg (Lond). 2024;86(6):3530-3534. doi:10.1097/MS9.0000000000002058

3. FDA accepts Viatris supplemental new drug application for MR-141 (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia. News release. Viatris Inc. February 25, 2026. Accessed October 19, 2026. https://newsroom.viatris.com/2026-02-25-FDA-Accepts-Viatris-Supplemental-New-Drug-Application-for-MR-141-Phentolamine-Ophthalmic-Solution-0-75-for-the-Treatment-of-Presbyopia

4. Ryzumvi (phentolamine ophthalmic solution) 0.75%. Prescribing information. Viatris Inc.; revised October 2026. Accessed October 19, 2026. https://www.ryzumvi.com/-/media/project/common/ryzumvicom/pdfs/Ryzumvi-US-PI.pdf

5. Opus Genetics announces VEGA-3 phase 3 trial met its primary endpoint for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia. News release. Opus Genetics, Inc. June 26, 2025. Accessed October 19, 2026. https://www.globenewswire.com/news-release/2025/06/26/3105692/0/en/Opus-Genetics-Announces-VEGA-3-Phase-3-Trial-Met-its-Primary-Endpoint-for-Phentolamine-Ophthalmic-Solution-0-75-for-the-Treatment-of-Presbyopia.html

6. Opus Genetics announces FDA approval of phentolamine ophthalmic solution 0.75% for the treatment of presbyopia. News release. Opus Genetics, Inc. October 16, 2026. Accessed October 19, 2026. https://www.globenewswire.com/news-release/2026/10/16/3382714/0/en/opus-genetics-announces-fda-approval-of-phentolamine-ophthalmic-solution-0-75-for-the-treatment-of-presbyopia.html