8-K: Harrow Secures Exclusive U.S. Rights to Key Ophthalmology Biosimilars

Harrow, Inc. has entered into an agreement with Samsung Bioepis to gain exclusive U.S. commercial rights for BYOOVIZ and OPUVIZ, two leading ophthalmology biosimilars, significantly expanding its market presence in retinal disease treatments.

Summary

• Harrow, Inc., through a wholly-owned subsidiary, entered into a development and commercialization agreement with Samsung Bioepis Co., Ltd. on July 17, 2025.
• Harrow gains exclusive U.S. commercial rights to BYOOVIZ (ranibizumab-nuna), an FDA-approved biosimilar referencing LUCENTIS, and OPUVIZ (aflibercept-yszy), an FDA-approved biosimilar referencing EYLEA.
• Harrow will make a one-time upfront payment to Samsung and Samsung will be eligible for additional one-time payments based on net sales-based milestones.
• Harrow will also pay Samsung a share of net sales from the Products generated in the U.S. market.
• Harrow will assume full commercial responsibility for BYOOVIZ in the U.S. upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis, which is expected by the end of 2025.
• The U.S. retinal disease treatment market represents a $9 billion opportunity.
• Current anti-VEGF therapies are among the most expensive drug categories covered under Medicare Part B, with annual spending exceeding $4.2 billion.

Sentiment

Score: 9

Explanation: The acquisition of exclusive U.S. commercial rights to two FDA-approved, high-value ophthalmology biosimilars significantly strengthens the company's market position, expands its product portfolio, and addresses a large, high-spending market with more affordable options, indicating strong growth potential and strategic alignment.

Positives

• Secures exclusive U.S. commercial rights to two FDA-approved ophthalmology biosimilars (BYOOVIZ and OPUVIZ), which are high-value assets.
• Enhances position as a leading full-spectrum ophthalmic pharmaceuticals provider in the U.S.
• Expands pipeline with high-value biosimilars for sight-threatening retinal diseases.
• Reinforces commitment to delivering value-oriented innovation and affordability to the U.S. eyecare market.
• Leverages growing commercial presence within the retina specialist community.
• Has the potential to substantially lower the financial burden on Medicare and commercial plans.
• Aims to improve access and affordability for patients requiring anti-VEGF therapies.
• BYOOVIZ is the first FDA-approved LUCENTIS biosimilar.

Risks

• Risks related to liquidity or results of operations.
• Ability to successfully implement the business plan, develop and commercialize products, product candidates, and proprietary formulations in a timely manner or at all.
• Ability to identify and acquire additional products.
• Ability to manage pharmacy operations.
• Ability to service debt.
• Ability to obtain financing necessary to operate the business.
• Ability to recruit and retain qualified personnel.
• Ability to manage any growth experienced and successfully realize the benefits of previous acquisitions and any other acquisitions and collaborative arrangements.
• 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.
• Uncertainties related to pharmacy operations and the pharmacy and pharmaceutical business in general.
• Physician interest in and market acceptance of current and any future formulations and compounding pharmacies generally.

Future Outlook

Harrow expects to leverage its established commercial infrastructure and national reach to accelerate the market impact of these biosimilars. The company 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 transition of commercial rights for BYOOVIZ and OPUVIZ is expected to be completed by the end of 2025.

Management Comments

• "This transformational acquisition marks a pivotal moment for Harrow and reinforces our commitment to delivering innovation, accessibility, and value to the U.S. ophthalmology community."
• "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."

Industry Context

The agreement positions Harrow to compete in the significant U.S. retinal disease treatment market, valued at $9 billion, which is currently dominated by branded therapies like EYLEA, LUCENTIS, VABYSMO, and off-label compounded Avastin. The introduction of biosimilars like BYOOVIZ and OPUVIZ is expected to expand patient access and affordability, potentially lowering the financial burden on Medicare and commercial plans, as current anti-VEGF therapies are among the most expensive drug categories under Medicare Part B, with annual spending exceeding $4.2 billion.

Comparison to Industry Standards

• BYOOVIZ (ranibizumab-nuna) is an FDA-approved biosimilar referencing LUCENTIS (ranibizumab), a trademark of Genentech, Inc.
• OPUVIZ (aflibercept-yszy) is an FDA-approved biosimilar referencing EYLEA (aflibercept), a trademark of Regeneron Pharmaceuticals, Inc.
• The market is currently dominated by branded therapies such as EYLEA, LUCENTIS, VABYSMO, and compounded Avastin.
• Harrow aims to offer an FDA-approved, on-label, and affordable alternative to these existing anti-VEGF therapies, which are among the most expensive drug categories covered under Medicare Part B.

Stakeholder Impact

• Shareholders: Potential for increased revenue, market share, and enhanced company value due to the acquisition of high-value assets in a significant market.
• Patients: Improved access and affordability for critical retinal disease treatments (Neovascular (Wet) Age-Related Macular Degeneration, Macular Edema following Retinal Vein Occlusion, Myopic Choroidal Neovascularization, Diabetic Macular Edema, and Diabetic Retinopathy).
• Eyecare Professionals: Access to FDA-approved, on-label, and affordable alternatives to existing anti-VEGF therapies.
• Medicare and Commercial Plans: Potential for substantially lower financial burden due to the availability of more affordable biosimilar options.

Next Steps

• Completion of the transition of commercial rights for BYOOVIZ and OPUVIZ from Biogen back to Samsung Bioepis.
• Harrow to assume full commercial responsibility for BYOOVIZ in the U.S. upon completion of the transition (expected by end of 2025).
• Harrow to commercialize BYOOVIZ and OPUVIZ in the U.S. market.

Key Dates

Recommendation

Keywords

Ophthalmology, Biosimilars, Retinal Disease, AMD, Macular Edema, Diabetic Retinopathy, Anti-VEGF, BYOOVIZ, OPUVIZ, Ranibizumab, Aflibercept, LUCENTIS, EYLEA, Pharmaceutical, Commercialization, Healthcare, Biologics