Harrow Launches FDA-Approved Byooviz Biosimilar
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jul 01 2026
0mins
Harrow announced the commercial launch of Byooviz, an FDA-approved biosimilar referencing Lucentisi and developed by Samsung Bioepis.
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Analyst Views on HROW
Wall Street analysts forecast HROW stock price to rise
7 Analyst Rating
7 Buy
0 Hold
0 Sell
Strong Buy
Current: 44.930
Low
63.00
Averages
72.40
High
94.00
Current: 44.930
Low
63.00
Averages
72.40
High
94.00
About HROW
Harrow, Inc. is a provider of ophthalmic disease management solutions. It offers a portfolio of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet age-related macular degeneration, cataracts, refractive errors, glaucoma and a range of other ocular surface conditions and retina diseases. It owns commercial rights to portfolios of branded ophthalmic pharmaceutical products in the United States, all of which are marketed under the Harrow name. It owns and operates ImprimisRx, an ophthalmology-focused pharmaceutical-compounding business. It owns United States commercial rights to various products: IHEEZO, VEVYE, TRIESENCE, VIGAMOX, FLAREX, NATACYN, BYQLOVI and others. Its development-stage programs include MELT-300, H-N08, CR-01, and MELT-210. VIGAMOX (moxifloxacin hydrochloride ophthalmic solution) 0.5%, a fluoroquinolone antibiotic eye drops for the treatment of bacterial conjunctivitis caused by susceptible strains of organisms.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Samsung Bioepis Partners with Harrow to Launch Ophthalmology Biosimilars
- Partnership Announcement: In July 2025, Samsung Bioepis entered into a partnership with Harrow to commercialize BYOOVIZ® and OPUVIZ™ in the U.S., marking a strategic expansion in the ophthalmology sector.
- Product Relaunch: BYOOVIZ® (ranibizumab-nuna), which received FDA approval in 2021 as the first ophthalmology biosimilar, is expected to enhance patient access to retinal disease treatments through Harrow's commercialization efforts.
- Market Potential: Wet Age-Related Macular Degeneration (AMD) affects approximately 1.2% to 1.3% of adults aged 65 and older in the U.S., providing strong demand support for BYOOVIZ and potentially alleviating the financial burden of existing anti-VEGF therapies.
- Strategic Implications: This relaunch represents not only a reinvestment in BYOOVIZ but also underscores Samsung Bioepis's long-term commitment to the ophthalmology market, aiming to help more patients access necessary vision-saving treatments.
See More
Harrow Launches First Ophthalmic Biosimilar BYOOVIZ
- Market Leadership: Harrow has secured exclusive U.S. commercialization rights for BYOOVIZ (ranibizumab-nuna) through a partnership with Samsung Bioepis, further solidifying its leadership position in the rapidly growing retinal biologics market, which is projected to reach $9 billion in the U.S.
- Product Innovation: BYOOVIZ, as the first FDA-approved ophthalmic biosimilar, is specifically designed for treating retinal diseases such as Neovascular (Wet) Age-Related Macular Degeneration, providing retina specialists with a clinically proven anti-VEGF therapy that enhances confidence and choice in patient care.
- Portfolio Expansion: The launch of BYOOVIZ complements Harrow's existing product lines, including IHEEZO and TRIESENCE, creating a comprehensive retinal product portfolio aimed at meeting the diverse needs of retina specialists, thereby improving patient treatment experiences and clinical outcomes.
- Market Demand Response: With increasing demand for therapies addressing retinal diseases, Harrow's introduction of BYOOVIZ underscores its commitment to the retina community and plans to continue investing in its retinal business to meet evolving market demands and patient expectations.
See More
Investment Outlook for Harrow, Inc. Stock
- Market Performance Review: As of June 8, Harrow, Inc. (HROW) shares traded at $33.10, and despite a 24.89% decline since last October, the company's rapid growth in the ophthalmic drug market continues to attract investor interest.
- Financial Growth Highlights: Revenue is projected to reach $272.3 million in 2025, reflecting a 36% year-over-year increase, while EBITDA is expected to rise 54% to $61.9 million, showcasing strong performance in prescription expansion and operational leverage improvements.
- Market Potential Analysis: Harrow's key products address multi-billion-dollar markets, including dry eye disease and the $8 billion+ anti-VEGF segment, with further growth anticipated from salesforce expansion and payer coverage gains.
- Investment Outlook Assessment: Analyst price targets near $71 imply about 86% upside over the next 12 months, supported by multiple near-term commercial and pipeline catalysts, indicating a highly asymmetric investment opportunity for HROW.
See More
Harrow Relaunches VERKAZIA to Enhance Pediatric Eye Disease Treatment
- Product Relaunch: Harrow has announced the relaunch of VERKAZIA (cyclosporine ophthalmic emulsion) 0.1%, aimed at providing effective treatment for pediatric vernal keratoconjunctivitis (VKC), addressing the significant gap in steroid-sparing therapies and expected to greatly enhance patient access to treatment.
- Market Demand: VKC is a serious allergic eye disease primarily affecting children, which can lead to vision impairment if untreated; Harrow's relaunch strategy focuses on educating physicians and patients to eliminate treatment barriers, thereby increasing diagnosis and treatment rates for this condition.
- Clinical Advantages: As a calcineurin inhibitor, VERKAZIA effectively reduces reliance on steroids, mitigating risks such as glaucoma and cataract formation in children, with clinical trials demonstrating significant improvements in corneal damage and hallmark symptoms.
- Strategic Positioning: Harrow's comprehensive commercial strategy emphasizes not only product accessibility but also affordability initiatives, aiming to ensure the long-term success of VERKAZIA in the ophthalmology market and meet the growing demand for effective treatment options.
See More
Harrow, Inc. Q1 2026 Earnings Call Insights
- Revenue Dynamics: Harrow, Inc. reported consolidated revenues of $44.2 million for Q1 2026, reflecting a decline primarily due to an $8 million reduction linked to VEVYE, highlighting the volatility in market demand and the urgency in the company's response to market challenges.
- Sales Team Expansion: The company has hired over 90 new sales professionals in Q1, indicating a proactive approach in market promotion and customer coverage, aimed at driving future revenue growth through enhanced sales capabilities.
- Future Outlook: Management reaffirmed the 2026 full-year revenue guidance of $350 million to $365 million, with expected Q2 revenues ranging from $71 million to $81 million, demonstrating confidence in future performance and positive market demand expectations.
- Strategic Goals: Harrow aims to achieve $250 million in quarterly revenue by the end of 2027, underscoring the company's long-term strategic objectives in business expansion and market share enhancement, particularly driven by the VEVYE and IHEEZO product lines.
See More
LogiCare3PL Selected as Distribution Partner for Harrow's Ophthalmic Solutions
- Partnership Formation: LogiCare3PL was officially selected as a distribution partner for Harrow, Inc. effective February 1, 2026, providing both non-title and 3PL title distribution services to support Harrow's product distribution across the U.S., thereby enhancing Harrow's market access capabilities.
- Rapid Implementation Capability: LogiCare3PL successfully onboarded Harrow within just four weeks, meeting Harrow's implementation timeline and ensuring business continuity, which significantly improves Harrow's responsiveness in the competitive ophthalmic disease management market.
- High-Touch Service Model: LogiCare3PL was chosen for its high-touch service model and proven ability to execute quickly and efficiently, which not only met Harrow's need for rapid market readiness but also laid the groundwork for a long-term partnership between the two companies.
- Future Collaboration Outlook: Both organizations anticipate continued collaboration as Harrow expands its product offerings, with LogiCare3PL providing a full suite of 3PL services to further enhance Harrow's competitive position in the ophthalmic sector.
See More
Samsung Bioepis Partners with Harrow to Launch Ophthalmology Biosimilars
- Partnership Announcement: In July 2025, Samsung Bioepis entered into a partnership with Harrow to commercialize BYOOVIZ® and OPUVIZ™ in the U.S., marking a strategic expansion in the ophthalmology sector.
- Product Relaunch: BYOOVIZ® (ranibizumab-nuna), which received FDA approval in 2021 as the first ophthalmology biosimilar, is expected to enhance patient access to retinal disease treatments through Harrow's commercialization efforts.
- Market Potential: Wet Age-Related Macular Degeneration (AMD) affects approximately 1.2% to 1.3% of adults aged 65 and older in the U.S., providing strong demand support for BYOOVIZ and potentially alleviating the financial burden of existing anti-VEGF therapies.
- Strategic Implications: This relaunch represents not only a reinvestment in BYOOVIZ but also underscores Samsung Bioepis's long-term commitment to the ophthalmology market, aiming to help more patients access necessary vision-saving treatments.
See More
Harrow Launches First Ophthalmic Biosimilar BYOOVIZ
- Market Leadership: Harrow has secured exclusive U.S. commercialization rights for BYOOVIZ (ranibizumab-nuna) through a partnership with Samsung Bioepis, further solidifying its leadership position in the rapidly growing retinal biologics market, which is projected to reach $9 billion in the U.S.
- Product Innovation: BYOOVIZ, as the first FDA-approved ophthalmic biosimilar, is specifically designed for treating retinal diseases such as Neovascular (Wet) Age-Related Macular Degeneration, providing retina specialists with a clinically proven anti-VEGF therapy that enhances confidence and choice in patient care.
- Portfolio Expansion: The launch of BYOOVIZ complements Harrow's existing product lines, including IHEEZO and TRIESENCE, creating a comprehensive retinal product portfolio aimed at meeting the diverse needs of retina specialists, thereby improving patient treatment experiences and clinical outcomes.
- Market Demand Response: With increasing demand for therapies addressing retinal diseases, Harrow's introduction of BYOOVIZ underscores its commitment to the retina community and plans to continue investing in its retinal business to meet evolving market demands and patient expectations.
See More
Investment Outlook for Harrow, Inc. Stock
- Market Performance Review: As of June 8, Harrow, Inc. (HROW) shares traded at $33.10, and despite a 24.89% decline since last October, the company's rapid growth in the ophthalmic drug market continues to attract investor interest.
- Financial Growth Highlights: Revenue is projected to reach $272.3 million in 2025, reflecting a 36% year-over-year increase, while EBITDA is expected to rise 54% to $61.9 million, showcasing strong performance in prescription expansion and operational leverage improvements.
- Market Potential Analysis: Harrow's key products address multi-billion-dollar markets, including dry eye disease and the $8 billion+ anti-VEGF segment, with further growth anticipated from salesforce expansion and payer coverage gains.
- Investment Outlook Assessment: Analyst price targets near $71 imply about 86% upside over the next 12 months, supported by multiple near-term commercial and pipeline catalysts, indicating a highly asymmetric investment opportunity for HROW.
See More
Harrow Relaunches VERKAZIA to Enhance Pediatric Eye Disease Treatment
- Product Relaunch: Harrow has announced the relaunch of VERKAZIA (cyclosporine ophthalmic emulsion) 0.1%, aimed at providing effective treatment for pediatric vernal keratoconjunctivitis (VKC), addressing the significant gap in steroid-sparing therapies and expected to greatly enhance patient access to treatment.
- Market Demand: VKC is a serious allergic eye disease primarily affecting children, which can lead to vision impairment if untreated; Harrow's relaunch strategy focuses on educating physicians and patients to eliminate treatment barriers, thereby increasing diagnosis and treatment rates for this condition.
- Clinical Advantages: As a calcineurin inhibitor, VERKAZIA effectively reduces reliance on steroids, mitigating risks such as glaucoma and cataract formation in children, with clinical trials demonstrating significant improvements in corneal damage and hallmark symptoms.
- Strategic Positioning: Harrow's comprehensive commercial strategy emphasizes not only product accessibility but also affordability initiatives, aiming to ensure the long-term success of VERKAZIA in the ophthalmology market and meet the growing demand for effective treatment options.
See More
Harrow, Inc. Q1 2026 Earnings Call Insights
- Revenue Dynamics: Harrow, Inc. reported consolidated revenues of $44.2 million for Q1 2026, reflecting a decline primarily due to an $8 million reduction linked to VEVYE, highlighting the volatility in market demand and the urgency in the company's response to market challenges.
- Sales Team Expansion: The company has hired over 90 new sales professionals in Q1, indicating a proactive approach in market promotion and customer coverage, aimed at driving future revenue growth through enhanced sales capabilities.
- Future Outlook: Management reaffirmed the 2026 full-year revenue guidance of $350 million to $365 million, with expected Q2 revenues ranging from $71 million to $81 million, demonstrating confidence in future performance and positive market demand expectations.
- Strategic Goals: Harrow aims to achieve $250 million in quarterly revenue by the end of 2027, underscoring the company's long-term strategic objectives in business expansion and market share enhancement, particularly driven by the VEVYE and IHEEZO product lines.
See More
LogiCare3PL Selected as Distribution Partner for Harrow's Ophthalmic Solutions
- Partnership Formation: LogiCare3PL was officially selected as a distribution partner for Harrow, Inc. effective February 1, 2026, providing both non-title and 3PL title distribution services to support Harrow's product distribution across the U.S., thereby enhancing Harrow's market access capabilities.
- Rapid Implementation Capability: LogiCare3PL successfully onboarded Harrow within just four weeks, meeting Harrow's implementation timeline and ensuring business continuity, which significantly improves Harrow's responsiveness in the competitive ophthalmic disease management market.
- High-Touch Service Model: LogiCare3PL was chosen for its high-touch service model and proven ability to execute quickly and efficiently, which not only met Harrow's need for rapid market readiness but also laid the groundwork for a long-term partnership between the two companies.
- Future Collaboration Outlook: Both organizations anticipate continued collaboration as Harrow expands its product offerings, with LogiCare3PL providing a full suite of 3PL services to further enhance Harrow's competitive position in the ophthalmic sector.
See More
