Viatris and Ocuphire Pharma Announce FDA Approval of RYZUMVl™ (Phentolamine Ophthalmic Solution) 0.75% Eye Drops for the Treatment of Pharmacologically-Induced Mydriasis Produced by Adrenergic Ago...

RYZUMVI Expected to be Commercially Available in the U.S. in the First Half of 2024  

PITTSBURGH, and FARMINGTON HILLS, Mich., Sept. 27, 2023 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, and Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved RYZUMVI^™ (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents.  RYZUMVl is expected to be commercially available in the U.S. in the first half of 2024.

"The FDA's approval of RYZUMVl marks a significant milestone for our Eye Care Division and underscores Viatris' commitment to advancing eye care and enhancing access for both eye care professionals and patients," said Viatris Eye Care Division President Jeffrey Nau, Ph.D.  "Comprehensive dilated eye exams are vital for early detection of vision-compromising diseases.  Our hope is that by addressing patient dilation barriers, we're empowering eye care professionals to broaden exam availability, leading to enhanced eye health outcomes.  We look forward to launching RYZUMVI in the first half of next year, and to continuing to advance our robust eye care pipeline which is aimed at addressing a range of vision-related disorders."

In the U.S., an estimated 100 million comprehensive eye exams take place each year that involve pharmacologically-induced mydriasis (or dilation) of the pupils[1], which can last up 24 hours².  Side effects of pharmacologically-induced mydriasis include sensitivity to light (photophobia)² and blurred vision², which may make it difficult to read, work and drive.^3,4

"We are pleased to receive FDA approval of RYZUMVI eye drops and look forward to Viatris' successful commercial execution," said Rick Rodgers, MBA, Interim Chief Executive Officer of Ocuphire.  "We are grateful to the many patients and investigators who participated in our clinical trials, as well as the Ocuphire and Viatris teams for their commitment to patients."

RYZUMVI was evaluated in the comprehensive MIRA clinical trial program involving more than 600 subjects, including the MIRA-1 Phase 2b trial, MIRA-2 and MIRA-3 Phase 3 pivotal trials, and MIRA-4 Phase 3 pediatric trial.  In the MIRA-2 and MIRA-3 trials, a total of 553 subjects aged 12 to 80 years, who had mydriasis induced by instillation of phenylephrine or tropicamide or a combination of hydroxyamphetamine hydrobromide and tropicamide (Paremyd) were randomized.  Two drops (study eye) or one drop (fellow eye) of RYZUMVI or placebo (vehicle) were administered one hour after instillation of the mydriatic agent.  The percentage of subjects with study eyes returning to ≤0.2 mm from baseline pupil diameter was statistically significantly greater (p<0.01) at all time points measured from 60 minutes through 24 hours in the RYZUMVI group compared with the placebo (vehicle) group across both of the MIRA-2 and MIRA-3 trials (see Figure 1 in the US PI).  The efficacy of RYZUMVI was similar for all age ranges including pediatric subjects aged 3 to 17 years.  Pediatric subjects aged 12 to 17 years (n=27) were treated in MIRA-2 and MIRA-3 and pediatric subjects, aged 3 to 11 years (n=11) were treated in MIRA-4.

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%).

About Pharmacologically-Induced Mydriasis

An estimated 100 million eye dilations are conducted every year in the U.S. to examine the retina (back-of-the-eye) either for routine check-ups, disease monitoring or surgical procedures[1]. Pharmacologically-induced mydriasis can last up to 24 hours in adults and children².  Side effects of pharmacologically-induced mydriasis include sensitivity to light (photophobia)² and blurred vision², which may make it difficult to read or work and drive^3,4.

About RYZUMVI^™ (Phentolamine Ophthalmic Solution) 0.75%

RYZUMVI is an anti-microbial preservative-free, topical eye drop formulation of phentolamine ophthalmic solution 0.75% that is FDA-approved to treat pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents.  RYZUMVI is a relatively non-selective alpha-1 and alpha-2 adrenergic agonist.  Dilation of the pupil is primarily controlled by the radial iris dilator muscles surrounding the pupil; these muscles are activated by the alpha-1 adrenergic receptors.  Phentolamine reversibly binds to these receptors on the iris dilator muscle, thereby reducing pupil diameter.  Phentolamine directly antagonizes the mydriatic effect of an α-1 adrenergic agonist, and indirectly reverses mydriasis induced by muscarinic antagonist effects on the iris sphincter muscle.

RYZUMVI^TMImportant 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%). 

Click here for full Prescribing Information.

About Viatris

Viatris Inc. (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life.  We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical, and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories. Viatris' portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases, including globally recognized brands, complex generic and branded medicines, and a variety of over-the-counter consumer products.  With more than 38,000 colleagues globally, Viatris is 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 Twitter, LinkedIn, Instagram and YouTube.

About Ocuphire Pharma

Ocuphire Pharma, Inc. is a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders.  Phentolamine is currently being developed in clinical trials for a number of refractive eye disorder indications in partnership with Viatris.  Ocuphire's lead retinal product candidate, APX3330, is a first-in-class small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein) in clinical development for diabetic retinopathy. APX3330 is not approved for use by any regulatory health authority in any country.

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 regarding FDA approval of RYZUMVI; regarding the expected commercial availability of RYZUMVI in the U.S. in the first half of 2024; and regarding the Viatris eye care pipeline. Forward-looking statements may often be identified by the use of words such as "expected" or "will" and variations of these words or comparable words. 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: actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market, including but not limited to "at-risk" launches; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the possibility that the Company may be unable to realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives; the possibility that the Company may be unable to achieve expected benefits, synergies and operating efficiencies in connection with acquisitions, divestitures, or its global restructuring program, within the expected timeframe or at all; impairment charges or other losses related to the divestiture or sale of businesses or assets; the Company's failure to achieve expected or targeted future financial and operating performance and results; the potential impact of public health outbreaks, epidemics and pandemics, including the ongoing challenges and uncertainties posed by COVID-19; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings; any significant breach of data security or data privacy or disruptions to our information technology systems; risks associated with international operations; the ability to protect intellectual property and preserve intellectual property rights; 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 and matters beyond the control of management, including general economic conditions, inflation and exchange rates; failure to execute stock repurchases consistent with current expectations; stock price volatility; 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 release other than as required by law.

OP-MYD-002609

¹ Wilson FA, Stimpson JP, Wang Y. Inconsistencies Exist in National Estimates of Eye Care Services Utilization in the United States. J Ophthalmol. 2015;2015:435606. doi: 10.1155/2015/435606. Epub 2015 Aug 9. PMID: 26346484; PMCID: PMC4546761
² PARAMYD® (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25% US Prescribing Information. Somerset, NJ.: Akorn, Inc.; 2001.
³ Goel S, Maharajan P, Chua C, Dong B, Butcher M, Bagga P. Driving ability after pupillary dilatation. Eye (Lond). 2003 Aug;17(6):735-8. doi: 10.1038/sj.eye.6700490. PMID: 12928686
⁴ Siderov J, Bartlett JR, Madigan CJ. Pupillary dilation: the patient's perspective. Clinical and Experimental Optometry. 1996;79(2):62-66. doi: 10.1111/j.1444-0938.1996.tb04976.

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