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Harrow Enters into Commercialization Agreement with Samsung Bioepis for Ophthalmology Biosimilars Portfolio in the United States Harrow to assume full commercial responsibility for BYOOVIZ and OPUVIZ by the end of 2025

Key Takeaway: Harrow (Nasdaq: HROW) has entered a commercialization agreement with Samsung Bioepis, acquiring U.S. commercial rights to the ophthalmology biosimilars BYOOVIZ and OPUVIZ. This strategic acquisition is expected to be completed by the end of 2025, allowing Harrow to enhance its portfolio in the retinal disease treatment market. The move is seen as a significant step in Harrow's commitment to delivering innovative and affordable eyecare solutions, as the retinal disease treatment market represents a substantial opportunity. CEO Mark L. Baum emphasized the potential for these products to improve patient access to vital therapies.

Market Sentiment Analysis

POSITIVE FACTORS

  • Harrow secures exclusive U.S. commercial rights for two FDA-approved biosimilars.
  • The acquisition enhances Harrow's position as a leading ophthalmic pharmaceutical provider.
  • BYOOVIZ and OPUVIZ are positioned to improve access and affordability for patients.

Full Press Release Details

Enters into Commercialization Agreement with Samsung Bioepis
Ophthalmology Biosimilars Portfolio in the United States
to assume full commercial responsibility for BYOOVIZ and OPUVIZ by the end of 2025
Tenn., July 17, 2025 - Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, today announced that it
has entered into a definitive agreement with Samsung Bioepis Co. Ltd. (hereafter "Samsung Bioepis") to secure the exclusive
U.S. commercial rights to the ophthalmology biosimilar portfolio of Samsung Bioepis -
BYOOVIZ (ranibizumab-nuna), an FDA-approved biosimilar referencing LUCENTISi (ranibizumab), and OPUVIZ
(aflibercept-yszy), an FDA-approved biosimilar referencing EYLEAii (aflibercept) -
two of the most widely used anti-VEGF therapies for retinal diseases.
has been commercialized by Biogen in the U.S. since its initial launch in June 2022. In October 2024, Biogen notified Samsung Bioepis
of their decision to terminate the 2019 Development and Commercialization Agreement within the U.S. and Canada. Samsung Bioepis has been
closely working with Biogen on the transfer of commercialization rights for BYOOVIZ and OPUVIZ back to Samsung Bioepis in these regions.
Harrow will assume full responsibility for commercialization of BYOOVIZ in the U.S. upon completion of the transition of commercial rights
from Biogen back to Samsung Bioepis. The transition is expected to be completed by the end of 2025.
strategic acquisition enhances Harrow's position as the leading full-spectrum ophthalmic pharmaceuticals provider in the U.S.,
expands its pipeline with high-value biosimilars for sight-threatening retinal diseases, and reinforces its commitment to delivering
value-oriented innovation to the U.S. eyecare market.
transformational acquisition marks a pivotal moment for Harrow and reinforces our commitment to delivering innovation, accessibility,
and value to the U.S. ophthalmology community," said Mark L. Baum, Chairman and Chief Executive Officer of Harrow. "We are
excited to leverage our growing commercial presence within the retina specialist community, built over the past year, and partner with
Samsung Bioepis, globally recognized for its scientific excellence in biologics and biosimilars. These ophthalmic assets are among the
most highly regarded in the market, and we are looking forward to bringing these products to U.S. physicians and patients."
BYOOVIZ (ranibizumab-nuna) 0.05mL injection, the first FDA-approved LUCENTIS biosimilar indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV).
OPUVIZ (aflibercept-yszy) 0.05mL injection , an FDA-approved EYLEA biosimilar indicated for the treatment of patients with Wet AMD, Macular Edema following RVO, Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).
Market Opportunity : The retinal disease treatment market represents a $9 billion opportunity iii in the U.S., with biosimilars expected to expand patient access and affordability.
Execution-Ready Platform: Harrow will leverage its established commercial infrastructure and national reach to accelerate the market impact of these biosimilars.
is committed to reshaping the Wet AMD treatment landscape by offering an FDA-approved, on-label, and affordable alternative to existing
anti-VEGF therapies. The market is dominated by EYLEA, LUCENTIS, VABYSMO, and compounded Avastin, which continues to be used off-label
due to its low cost, despite not being formulated or approved for ocular administration. Current anti-VEGF therapies are among the most
expensive drug categories covered under Medicare Part B, with annual spending in the U.S. exceeding $4.2 billioniv. Harrow's
acquisition of these products has the potential to substantially lower the financial burden on Medicare and commercial plans, while improving
access and affordability for patients.
i Lucentis is a trademark of Genentech, Inc.
ii Eylea is a trademark of Regeneron Pharmaceuticals, Inc.
iii Company annual reports & Biopharma AVASTIN estimates
iv https://www.reviewofoptometry.com/news/article/annual-medicare-expense-for-antivegf-injections-tops-4-billion-study-finds
BYOOVIZ (ranibizumab-nuna)
(ranibizumab-nuna) injection, for intravitreal use.
(ranibizumab-nuna) is biosimilar to LUCENTIS (ranibizumab injection).
a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:
(Wet) Age-Related Macular Degeneration (AMD)
Edema Following Retinal Vein Occlusion (RVO)
Choroidal Neovascularization (mCNV)
Important Safety Information
and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection.
in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection.
is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.
most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage,
eye pain, vitreous floaters, and increased IOP.
see Prescribing Information for BYOOVIZ (ranibizumab-nuna) HERE.
OPUVIZ (aflibercept-yszy)
(aflibercept-yszy) injection, for intravitreal use.
(aflibercept-yszy) is biosimilar to EYLEA (aflibercept).
is a vascular endothelial growth factor (VEGF) inhibitor, indicated for the treatment of patients with:
(Wet) Age-Related Macular Degeneration (AMD)
Edema Following Retinal Vein Occlusion (RVO)
Important Safety Information
retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers
should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without
delay and should be managed appropriately.
in intraocular pressure have been seen within 60 minutes of an intravitreal injection.
is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.
most common adverse reactions ( 5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous
detachment, vitreous floaters, and intraocular pressure increased.
see Prescribing Information for OPUVIZ (aflibercept-yszy) HERE.
Inc. (Nasdaq: HROW) is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative
ophthalmic pharmaceutical products for the North American market. Harrow helps eyecare professionals preserve the gift of sight by making
its portfolio of pharmaceutical products accessible and affordable to millions of patients each year. For more information about Harrow,
please visit harrow.com.
press release contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act
of 1995. Any statements in this release that are not historical facts may be considered such "forward-looking statements."
Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may
cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties
that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations;
our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations
in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing
necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize
the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical
companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges;
regulatory and legal risks, including litigation matters, and other uncertainties related to our pharmacy operations and the pharmacy
and pharmaceutical business in general; physician interest in and market acceptance of our current and any future formulations and compounding
pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow's filings with the Securities
and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports
on Form 10-Q, and other filings with the SEC. Such documents may be read free of charge on the SEC's web site at sec.gov.
Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required
by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances
after the date they are made, or to reflect the occurrence of unanticipated events.
Contacts:
Investors: Media:
Mike Biega, VP of Investor Relations and Communications Silvana Guerci-Lena, Powers & Co.
mbiega@harrowinc.com silvana@powers-co.com
617-913-8890 508-808-8993

Frequently Asked Questions

What companies are involved in the commercialization agreement?

Harrow has entered into an agreement with Samsung Bioepis for U.S. rights.

What products will Harrow commercialize?

Harrow will commercialize BYOOVIZ and OPUVIZ, both FDA-approved biosimilars.

When will Harrow assume commercial responsibility?

Harrow will assume full commercial responsibility by the end of 2025.

What is the market opportunity for retinal diseases?

The retinal disease treatment market represents a $9 billion opportunity.

What benefits do the biosimilars provide?

The biosimilars aim to improve access and affordability for patients.

Last updated: Jul 17, 2025