Opus Genetics Announces FDA Approval of Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia

The expanded indication marks Opus Genetics’ second U.S. drug approval.

Rhea-AI Summary

Opus Genetics (Nasdaq: IRD) received FDA approval for phentolamine ophthalmic solution 0.75% to treat presbyopia, age-related difficulty focusing on nearby objects, in adults.

The supplemental approval expands the uses of RYZUMVI, already marketed in the United States to treat drug-induced pupil dilation. It will trigger a milestone payment to Opus Genetics. Under a global licensing agreement, Viatris, through an affiliated entity, holds exclusive U.S. commercialization rights.

The approval was supported by the pivotal Phase 3 VEGA-2 and VEGA-3 trials. Both met their primary and all key secondary efficacy endpoints, with no treatment-related serious adverse events reported. In the presbyopia safety information, the most common ocular adverse reactions were eye redness (21%) and irritation at the application site (16%).

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Positive

• Major pointFDA approval expands phentolamine ophthalmic solution 0.75% to treat presbyopia in adults.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Presbyopia approval will trigger a milestone payment to Opus Genetics.
• Minor pointVEGA-2 and VEGA-3 both met their primary and all key secondary efficacy endpoints.
• Minor pointNo treatment-related serious adverse events were reported in the pivotal Phase 3 trials.

Negative

• None.

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Key Figures

Solution concentration: 0.75% Adults affected: Approximately 90% Conjunctival hyperemia: 21% +1 more

Solution concentration

0.75%

Phentolamine ophthalmic solution

Adults affected

Approximately 90%

U.S. adults over age 45 with presbyopia

Conjunctival hyperemia

21%

Most common ocular adverse reaction reported for presbyopia

Instillation site irritation

16%

Most common ocular adverse reactions reported for presbyopia

Key Terms

snda, mydriasis, sympatholytic mechanism of action, conjunctival hyperemia

4 terms

snda regulatory

"approved the Company’s supplemental New Drug Application (sNDA)"

A SNDA (Subordination, Non‑Disturbance and Attornment Agreement) is a legal pact among a property owner’s lender, the owner’s tenants, and sometimes the landlord that sets who keeps lease rights if the property is sold or a mortgage is enforced. Think of it as a rulebook that decides whether a tenant can stay and keep paying rent or must answer to a new owner after a foreclosure. For investors, an SNDA matters because it protects predictable rental income, clarifies who has priority on claims against a property, and therefore affects a property’s value and the security of related loans.

mydriasis medical

"for the treatment of pharmacologically induced mydriasis"

Mydriasis is the widening or dilation of the pupil, the dark center of the eye, that lets in more light—similar to a camera aperture opening wider. It can occur naturally in low light, because of certain medications, or as a side effect of treatments and is important to investors because it is a measurable clinical sign used in drug trials, ophthalmic product evaluations, and safety assessments that can affect regulatory reviews and market potential.

sympatholytic mechanism of action medical

"through a sympatholytic mechanism of action"

A sympatholytic mechanism of action is how a drug or therapy reduces activity of the sympathetic nervous system — the part of the autonomic nervous system that drives ‘fight-or-flight’ responses. It does this by blocking adrenergic receptors (for example alpha or beta blockers), inhibiting release or synthesis of norepinephrine, or acting on central nervous system pathways that control sympathetic outflow; the result is reduced signals that normally raise heart rate, blood pressure and vascular tone. Different sympatholytic agents work at different sites (receptor blockade versus neurotransmitter suppression versus central inhibition), which determines their specific physiological effects and side-effect profiles.

conjunctival hyperemia medical

"conjunctival hyperemia (21%) and instillation site irritation (16%)"

Conjunctival hyperemia is the medical term for visible redness of the white part of the eye caused by increased blood flow in the eye’s surface vessels, similar to how skin can flush when irritated. For investors, it matters because it’s a common side effect tracked in clinical trials and product safety reports—frequent or severe cases can affect a drug or device’s regulatory approval, labeling, patient acceptance and ultimately market potential.

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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

Approval supported by positive results from pivotal Phase 3 VEGA-2 and VEGA-3 trials, which met primary and all key secondary efficacy endpoints

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

Opus Genetics and Viatris Inc. (through an affiliated entity) are parties to a global licensing agreement which provides for the development of phentolamine ophthalmic solution 0.75% and grants exclusive rights to Viatris to commercialize the product in the United States.

This FDA approval in presbyopia will trigger a milestone payment to Opus Genetics.

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.

“This approval marks an important milestone for Opus Genetics, representing our second U.S. drug approval and underscoring our clinical and regulatory capabilities,” said George Magrath, M.D., Chief Executive Officer, Opus Genetics. “It 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^® to patients.”

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.

Phentolamine ophthalmic solution 0.75% is marketed in the United States as RYZUMVI^® for the treatment of pharmacologically induced mydriasis. The supplemental approval expands its approved indications to include presbyopia in adults.

INDICATIONS AND USAGE

RYZUMVI^® (phentolamine ophthalmic solution) 0.75% is indicated for:

• Treatment of presbyopia in adults
• Treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic agents (e.g., tropicamide) in adults and pediatric patients 3 years of age and older
  
  

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Uveitis: RYZUMVI is not recommended to be used in patients with active ocular inflammation (e.g., iritis).

Potential for Eye Injury or Contamination: To avoid the potential for eye injury or contamination, care should be taken to avoid touching the vial tip to the eye or to any other surface.

Use with Contact Lenses: Contact lens wearers should be advised to remove their lenses prior to the instillation of RYZUMVI and wait 10 minutes after dosing before reinserting their contact lenses.

Adverse Reactions

Presbyopia

The most common ocular adverse reactions reported in > 5% of subjects were conjunctival hyperemia (21%) and instillation site irritation (16%).

Pharmacologically-induced Mydriasis

The most common ocular adverse reactions reported in > 5% of subjects were instillation site discomfort including pain, stinging, and burning (16%) and conjunctival hyperemia (12%). The only non-ocular adverse reaction reported in > 5% of subjects was dysgeusia (6%). The majority of the adverse reactions were mild, transient and self-resolving.

Please see complete Prescribing Information

About Phentolamine Ophthalmic Solution 0.75%

Phentolamine ophthalmic solution 0.75% is a non-selective alpha-1 and alpha-2 adrenergic antagonist to reduce pupil size, administered as an eye drop. It works by blocking alpha-1 adrenergic receptors on the iris dilator muscle. Phentolamine ophthalmic solution 0.75% is designed to reduce pupil diameter through a sympatholytic mechanism of action that avoids engaging the ciliary muscle. Phentolamine ophthalmic solution 0.75% is currently approved in the U.S. for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents; and has successfully completed a Phase 3 program for presbyopia (VEGA clinical program), and is being evaluated in a Phase 3 program for the treatment of dim (mesopic) light vision disturbances (sometimes referred to as DLD) after keratorefractive surgery (LYNX clinical program).

About Opus Genetics

Opus Genetics is a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs). The Company is developing durable, one-time treatments designed to address the underlying genetic causes of severe retinal disorders. The Company’s pipeline includes seven AAV-based programs, led by OPGx-LCA5 for LCA5-related mutations and OPGx-BEST1 for BEST1-related retinal degeneration, with additional candidates targeting RDH12, MERTK, RHO, CNGB1 and NMNAT1. The Company is based in Research Triangle Park, NC. For more information, visit www.opusgtx.com.

Forward-Looking Statements

This press release contains certain statements that are not statements of historical fact and are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “aim,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “strive,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Such statements include, but are not limited to, statements related to the Company’s commercialization and future plans for phentolamine ophthalmic solution 0.75%, the Company’s belief in the strength of its clinical and regulatory teams, the Company’s commitment to advancing innovative ophthalmic therapies that address unmet patient needs, and the Company’s expectations regarding its business prospects and results of operations. The forward-looking statements contained herein are subject to certain risks and uncertainties posed by many factors and events that could cause the Company’s actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading “Risk Factors” included in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2025, its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, and in the Company’s other filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. The Company undertakes no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise.

Contacts:

Investors
Jenny Kobin
Remy Bernarda
IR Advisory Solutions
ir@opusgtx.com

Media

Kimberly Ha
KKH Advisors
917-291-5744
kimberly.ha@kkhadvisors.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did the FDA approve for Opus Genetics’ RYZUMVI?

The FDA approved phentolamine ophthalmic solution 0.75% for treating presbyopia in adults. The supplemental approval adds this indication to RYZUMVI’s existing approved use for drug-induced pupil dilation.

What does the RYZUMVI presbyopia approval mean for Opus Genetics financially?

The approval will trigger a milestone payment to Opus Genetics. Viatris, through an affiliated entity, holds exclusive rights to commercialize the product in the United States under the companies’ global licensing agreement.