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
drive3,4.
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.
RYZUMVITM 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%).
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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SOURCE Viatris Inc.