Phenylephrine Hydrochloride

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 . 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

PITTSBURGH, Oct. 16, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved RYZUMVI® (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia in adults. RYZUMVI is currently approved in the United States for the treatment of pharmacologically-induced mydriasis and is the only commercially available FDA-approved product for that use. This approval expands the product's indications to include presbyopia. Viatris is exploring the potential for a partner in the United States to commercialize RYZUMVI for the treatment of presbyopia. About Opus Genetics and Viatris Collaboration 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. About Presbyopia Presbyopia is the gradual loss of near focusing ability due to aging, that typically becomes noticeable in the early to mid-40s. It is a nearly universal condition that, when uncorrected, contributes significantly to vision-related disability. Presbyopia leads to symptoms like eye strain and blurred near vision, impacting daily tasks and productivity. 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 Viatris Viatris Inc. (Nasdaq: VTRS) is a global healthcare company whose mission is to empower people worldwide to live healthier at every stage of life. We meet the needs of patients around the world by acting decisively with ingenuity and resolve. Whether we're developing new medicines, working to maintain a resilient supply of needed therapies, or pursuing bold innovation, we strive to deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a broad portfolio that spans generics, value-added medicines, established brands, and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X. Forward-Looking Statements This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements about the approval of RYZUMVI® for the treatment of presbyopia in adults; and Viatris is exploring the potential for a partner in the United States to commercialize RYZUMVI for the treatment of presbyopia. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: failure to achieve the intended benefits of our strategic initiatives and priorities; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; failure to achieve expected or targeted future financial and operating performance and results; Viatris' or its partners' ability to develop, manufacture, and commercialize products; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development and/or that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; any significant breach of data security or data privacy or disruptions to our IT systems; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law. SOURCE Viatris Inc. 21% more press release views with Request a Demo