Harrow's Strategic Move to Dominate the Ophthalmology Biosimilars Market

The U.S. ophthalmology biosimilars market is on the cusp of a seismic shift, driven by Harrow, Inc. (NASDAQ: HROW) and its strategic partnership with Samsung Bioepis. This collaboration, which grants Harrow exclusive U.S. commercial rights to two FDA-approved biosimilars—BYOOVIZ (ranibizumab-nuna) and OPUVIZ (aflibercept-yszy)—positions the company to disrupt a $9 billion retinal disease treatment market dominated by high-cost therapies like LUCENTIS and EYLEA. By acquiring these biosimilars, Harrow is not just securing a competitive edge but reshaping the entire industry landscape.

The Market Opportunity: A $9 Billion Goldmine

The U.S. retinal disease treatment market is a cash-rich, high-margin sector. Anti-VEGF therapies like LUCENTIS and EYLEA, which treat conditions such as wet AMD and diabetic retinopathy, generated over $4.2 billion in annual Medicare Part B spending in 2025. These drugs, while effective, come with price tags that strain healthcare systems and limit patient access. Harrow's biosimilars—BYOOVIZ and OPUVIZ—offer a 30–40% wholesale acquisition cost (WAC) reduction, making them a compelling alternative for payers, providers, and patients.

The biosimilar market in ophthalmology is still in its early stages of adoption, but trends are accelerating. Samsung Bioepis' Q1 2025 report noted that ophthalmology biosimilars achieved an average 81% market share within five years post-launch. With Harrow's commercial infrastructure and national reach, the company is uniquely positioned to fast-track this transition.

Strategic Shift: From Biogen to Harrow

The partnership with Samsung Bioepis is a masterstroke. In October 2024, Biogen terminated its 2019 agreement to commercialize BYOOVIZ and OPUVIZ in the U.S., creating a vacuum that Harrow has swiftly filled. By the end of 2025, Harrow will assume full responsibility for these products, inheriting a proven FDA-approved portfolio with established clinical validation. This transition eliminates the risk of fragmented commercialization and allows Harrow to directly monetize the biosimilars' growth potential.

BYOOVIZ, the first ophthalmology biosimilar, has already proven its viability since its 2022 launch. OPUVIZ, approved in May 2024, targets a broader range of indications, including diabetic retinopathy. Together, these products form a high-value pipeline that aligns with Harrow's mission to deliver “value-oriented innovation” in eyecare.

Market Leadership Through Cost Efficiency and Scale

Harrow's commercial infrastructure is a critical differentiator. The company has built a robust network of retina specialists and ophthalmologists, enabling rapid adoption of its products. Unlike smaller biosimilar players, Harrow can leverage its existing sales force to promote BYOOVIZ and OPUVIZ as cost-effective alternatives to LUCENTIS and EYLEA.

The competitive landscape is also shifting in Harrow's favor. EYLEA, currently the market leader with a 36–40% share, lacks a biosimilar competitor in the U.S. OPUVIZ could disrupt this dominance by offering a lower-cost, equally effective option. Meanwhile, BYOOVIZ is already eroding LUCENTIS' market share, which sits at 38–42%. With Harrow now in control, the company can accelerate these trends through aggressive pricing and physician education.

Financial Implications: Profitability and Growth

Harrow's financials underscore its readiness for this leap. The company reported a 53.5% revenue increase in the last twelve months, with a gross margin of 74.5%. Q1 2025 revenue hit $47.8 million, up 38% year-over-year, though slightly below analyst expectations. However, the acquisition of BYOOVIZ and OPUVIZ is expected to drive revenue past $280 million in 2025, fueled by the biosimilars' market potential.

Analysts are bullish. Cantor Fitzgerald, H.C. Wainwright, and William Blair have assigned price targets ranging from $60 to $62, with “Buy” or “Overweight” ratings. These projections reflect confidence in Harrow's ability to capture a significant portion of the $9 billion market.

Risks and Mitigants

While the outlook is positive, risks remain. Biosimilars face regulatory hurdles and payer formulary challenges. However, Harrow's partnership with Samsung Bioepis provides technical and regulatory support, reducing development and compliance risks. Additionally, the FDA's streamlined approval process—waiving phase 3 trials in certain cases—accelerates time-to-market, giving Harrow a speed advantage.

Investment Thesis: A High-Conviction Play

Harrow's partnership with Samsung Bioepis is a catalyst for market leadership. By securing exclusive rights to two high-margin biosimilars, the company is poised to:
1. Capture 15–20% of the U.S. retinal disease market within three years, generating $1.35–$1.8 billion in annual revenue.
2. Drive EBITDA margins above 30% by leveraging cost efficiencies and scale.
3. Outperform peers in growth and profitability, with a P/E ratio of 25x (as of Q2 2025) offering room for upside.

For investors, this is a high-conviction opportunity. Harrow is not just a biosimilar provider—it's a disruptor with the infrastructure, product pipeline, and strategic vision to redefine an industry.

Conclusion
The U.S. ophthalmology biosimilars market is at a tipping point. Harrow's strategic acquisition of BYOOVIZ and OPUVIZ, combined with its commercial prowess, positions it as the clear leader in this transformation. With a $9 billion market to target and a regulatory tailwind, Harrow offers a compelling long-term investment for those looking to capitalize on the shift toward affordable, high-quality healthcare solutions.