Opus Genetics (Nasdaq: IRD) announced the FDA has accepted the supplemental New Drug Application for phentolamine ophthalmic solution 0.75% to treat presbyopia, with a PDUFA goal date of October 17, 2026.
Phase 3 trials VEGA-2 and VEGA-3 met primary and all key secondary endpoints with no treatment-related serious adverse events. RYZUMVI is already approved in the U.S. for pharmacologic mydriasis, and Opus has a global U.S. commercialization license with Viatris. VEGA-3 data will be presented at ASCRS (April 2026) and ARVO (May 2026).
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Positive
FDA acceptance of sNDA with PDUFA date Oct 17, 2026
Phase 3 VEGA-2 and VEGA-3 met primary and all key secondary endpoints
No treatment-related serious adverse events reported in pivotal program
Existing U.S. approval and commercialization license with Viatris
Common adverse reactions: instillation site discomfort 16%, conjunctival hyperemia 12%, dysgeusia 6%
Key Figures
PDUFA goal date:October 17, 2026Drug concentration:0.75%Effect duration:up to 20 hours+5 more
8 metrics
PDUFA goal dateOctober 17, 2026FDA review timeline for phentolamine ophthalmic solution 0.75% in presbyopia
Drug concentration0.75%Phentolamine ophthalmic solution strength for presbyopia and other indications
Effect durationup to 20 hoursSustained effect on pupil diameter for near‑vision improvement
Presbyopia prevalence90% of U.S. adults over 45Proportion of adults impacted by presbyopia in the United States
Instillation site discomfort16%Most common adverse reaction to RYZUMVI in clinical experience
Conjunctival hyperemia12%Reported adverse reaction frequency for RYZUMVI
Dysgeusia6%Reported adverse reaction frequency for RYZUMVI
Phase 3 trials count2 trialsVEGA‑2 and VEGA‑3 pivotal trials supporting the sNDA for presbyopia
Market Reality Check
Price:$3.64Vol:Volume 1,738,255 is 1.42x...
normal vol
$3.64Last Close
VolumeVolume 1,738,255 is 1.42x the 20-day average of 1,223,797, indicating elevated trading interest ahead of the FDA review.normal
TechnicalShares at $3.64 are trading above the 200-day MA of $1.71, reflecting a pre-news upswing from prior levels.
Peers on Argus
IRD rose 5.51% while closely ranked biotech peers showed mixed, mostly modest mo...
1 Up
IRD rose 5.51% while closely ranked biotech peers showed mixed, mostly modest moves (e.g., IMUX +5.68%, OVID +4.14%, OKYO -0.6%). Momentum scans highlighted only QNCX at +23.13%, suggesting today’s IRD move is company-specific rather than a broad sector rotation.
First patient dosed in pivotal LYNX‑3 Phase 3 phentolamine trial in keratorefractive patients.
Pattern Detected
Clinical and regulatory updates have produced mixed stock reactions: 3 positive-alignment moves and 2 negative divergences, with an average same-tag move of -1.28%.
Recent Company History
Over the past several months, Opus Genetics has reported multiple clinical milestones across its gene therapy pipeline and small-molecule ophthalmic programs. Same-tag events include initiation and safety de-risking of BEST1 and LCA5 gene therapy trials and the MERTK retinitis pigmentosa study, as well as pivotal work on phentolamine ophthalmic solution. Price reactions have varied, with some positive data (e.g., BEST1 and LCA5 readouts) seeing selloffs. Today’s FDA acceptance and PDUFA date for presbyopia extends this clinical-progress narrative into a partnered, late-stage asset.
Historical Comparison
-1.3% avg move · In the past year, IRD’s 5 clinical‑trial‑tagged updates averaged a -1.28% move. Today’s +5.51% react...
clinical trial
-1.3%
Average Historical Moveclinical trial
In the past year, IRD’s 5 clinical‑trial‑tagged updates averaged a -1.28% move. Today’s +5.51% reaction to FDA sNDA acceptance for presbyopia is stronger than prior typical responses.
Clinical activity shows a progression from first‑in‑human dosing and safety milestones in BEST1 and LCA5, to initiation of the MERTK program and pivotal LYNX‑3 for phentolamine, now advancing to an sNDA with a defined PDUFA date.
Market Pulse Summary
This announcement details FDA acceptance of Opus Genetics’ sNDA for phentolamine ophthalmic solution...
Analysis
This announcement details FDA acceptance of Opus Genetics’ sNDA for phentolamine ophthalmic solution 0.75% in presbyopia, with a PDUFA goal date of October 17, 2026. The filing is backed by two pivotal Phase 3 trials, VEGA‑2 and VEGA‑3, which met primary and key secondary endpoints without treatment‑related serious adverse events. In context of prior BEST1, LCA5, and MERTK trial updates, investors may watch for forthcoming VEGA‑3 data presentations and any additional safety or efficacy signals as key milestones.
Key Terms
pdufa, snda, presbyopia, uveitis, +2 more
6 terms
pdufaregulatory
"The FDA has assigned a PDUFA goal date of October 17, 2026."
PDUFA, short for the Prescription Drug User Fee Act, is a law that allows drug companies to pay fees to the government to speed up the review process for new medicines. This helps bring important drugs to market more quickly, which can impact their availability and pricing. For investors, PDUFA timelines can influence the timing of a drug’s approval and potential market success.
sndaregulatory
"the FDA has accepted for review the supplemental New Drug Application (sNDA) for phentolamine..."
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.
presbyopiamedical
"for the treatment of presbyopia. The FDA has assigned a PDUFA goal date..."
Presbyopia is the gradual loss of the eye’s ability to focus on close objects as the lens stiffens with age, causing tasks like reading or using a phone to require holding things farther away or using glasses. It matters to investors because it drives steady demand for corrective products and treatments—such as reading glasses, contact lenses, surgical procedures and emerging drugs—much like an aging population consistently needs new or replacement consumer goods and services.
uveitismedical
"Uveitis: RYZUMVI is not recommended to be used in patients with active ocular inflammation..."
Uveitis is inflammation inside the eye that can damage tissues responsible for clear vision, causing pain, light sensitivity, blurred sight, or permanent vision loss if untreated. For investors, it matters because it represents a medical condition with significant unmet need and chronic treatment requirements, influencing the size of potential drug or device markets, clinical trial design and endpoints, regulatory hurdles, and long-term revenue prospects — similar to how chronic engine trouble signals ongoing repair and maintenance demand.
dysgeusiamedical
"The most common adverse reactions that have been reported are... conjunctival hyperemia (12%), and dysgeusia (6%)."
Dysgeusia is a change, loss or distortion of the sense of taste — for example foods tasting metallic, bitter, or bland when they normally would not. Investors should care because it is a common drug or device side effect and a consumer-product complaint that can reduce patient adherence, trigger regulatory scrutiny or product recalls, and harm sales and reputations much like a familiar food suddenly tasting off-putting to everyone.
phase 3medical
"The sNDA is supported by data from a pivotal Phase 3 clinical program, including two trials, VEGA-2 and VEGA-3."
Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.
AI-generated analysis. Not financial advice.
FDA PDUFA Goal Date Set for October 17, 2026
RESEARCH TRIANGLE PARK, N.C., Feb. 25, 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 accepted for review the supplemental New Drug Application (sNDA) for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia. The FDA has assigned a PDUFA goal date of October 17, 2026.
Presbyopia is an age-related condition that affects the ability to focus on near objects and impacts millions of adults worldwide, often requiring reading glasses or other visual aids. If approved, phentolamine ophthalmic solution 0.75% has the potential to offer a pharmacologic treatment option for patients seeking improved visual acuity without reliance on corrective lenses. The condition affects approximately 90% of adults in the U.S. over the age of 45.
“The FDA’s acceptance of our sNDA marks an important milestone in expanding the potential use of phentolamine ophthalmic solution as a differentiated approach to managing presbyopia,” said George Magrath, M.D., Chief Executive Officer, Opus Genetics. “Phentolamine is targeted to improve near vision while preserving distance vision, with a sustained effect on pupil diameter of up to 20 hours. Our team continues to make tremendous progress in advancing our mission to bring meaningful new ophthalmic treatment options to patients.”
Phentolamine ophthalmic solution 0.75% is a preservative-free, topical ophthalmic formulation designed to modulate pupil dynamics and improve visual acuity through a sympatholytic mechanism of action that avoids engaging the ciliary muscle.
The sNDA is supported by data from a pivotal Phase 3 clinical program, including two trials, VEGA-2 and VEGA-3. Both trials demonstrated positive efficacy results for this investigational non-invasive treatment option for presbyopia, meeting the primary and all key secondary endpoints, with no treatment-related serious adverse events. The Company intends to have data from VEGA-3 presented at the American Society of Cataract and Refractive Surgery (ASCRS) meeting in April 2026 in Washington, D.C. and the Association for Research in Vision and Ophthalmology (ARVO) meeting in May 2026 in Denver, Colorado. Phentolamine ophthalmic solution 0.75% is also being investigated across additional ophthalmic indications.
Ryzumvi ® (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 is the only commercially available FDA-approved product for this use. The sNDA seeks to expand the indication to include presbyopia.
Opus Genetics and Viatris, Inc. (Viatris) (through its affiliate) 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 phentolamine ophthalmic solution 0.75% in the U.S.
RYZUMVI® 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
The most common adverse reactions that have been reported are instillation site discomfort (16%), conjunctival hyperemia (12%), and dysgeusia (6%).
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, potentially reducing risks such as retinal tears or detachment associated with parasympathomimetic agents. 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 RHO, CNGB1, RDH12, NMNAT1, and MERTK. Opus Genetics is also advancing Phentolamine ophthalmic solution 0.75%, an approved small-molecule therapy for pharmacologically induced mydriasis, with additional potential indications in presbyopia and low-light visual disturbances following keratorefractive surgery. The Company is based in Research Triangle Park, NC. For more information, visit www.opusgtx.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements related to the clinical development, clinical results, preclinical data, and future plans for Phentolamine ophthalmic solution 0.75% and expectations regarding us, our business prospects, and our results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause our 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 our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, our subsequent Quarterly Reports on Form 10-Q, and in our 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 our 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. 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. We undertake 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
What did Opus Genetics (IRD) announce about the phentolamine 0.75% sNDA on February 25, 2026?
The company announced the FDA accepted the sNDA for phentolamine 0.75% with a PDUFA date of October 17, 2026. According to the company, Phase 3 trials VEGA-2 and VEGA-3 met primary and key secondary endpoints with no treatment-related serious adverse events.
How did VEGA-2 and VEGA-3 results support Opus Genetics' (IRD) presbyopia filing?
Both Phase 3 trials met the primary and all key secondary endpoints, supporting efficacy claims. According to the company, the pivotal program showed positive efficacy and no treatment-related serious adverse events, forming the basis for the sNDA submission.
When is the FDA decision expected for Opus Genetics' (IRD) presbyopia sNDA?
The FDA assigned a PDUFA goal date of October 17, 2026 for the sNDA review. According to the company, that date represents the target FDA action deadline for the supplemental application decision.
Will Opus Genetics (IRD) present additional phentolamine data at upcoming meetings in 2026?
Yes. The company intends to present VEGA-3 data at ASCRS in April 2026 and at ARVO in May 2026. According to the company, those presentations will share pivotal trial data supporting the presbyopia indication.
What safety information did Opus Genetics (IRD) disclose for RYZUMVI (phentolamine 0.75%)?
The most common adverse reactions reported are instillation site discomfort (16%), conjunctival hyperemia (12%), and dysgeusia (6%). According to the company, RYZUMVI is not recommended for active ocular inflammation and has labeled usage precautions.
