Harrow Enters into Commercialization Agreement with Samsung Bioepis for Ophthalmology Biosimilars Portfolio in the United States
NASHVILLE, July 17, 2025--(BUSINESS WIRE)--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.
BYOOVIZ 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.
This 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.
"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," 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."
Transaction Highlights
Acquired Rights: Harrow gains exclusive U.S. commercial rights to Samsung Bioepis' portfolio of ophthalmic biosimilars, including BYOOVIZ® ("bio-viss") and OPUVIZ™ ("op-u-vis"):
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 opportunityiii 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.
Harrow 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.
About BYOOVIZ (ranibizumab-nuna)
BYOOVIZ (ranibizumab-nuna) injection, for intravitreal use.BYOOVIZ (ranibizumab-nuna) is biosimilar to LUCENTIS (ranibizumab injection).BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:Neovascular (Wet) Age-Related Macular Degeneration (AMD)Macular Edema Following Retinal Vein Occlusion (RVO)Myopic Choroidal Neovascularization (mCNV)
Select Important Safety Information
WARNING AND PRECAUTIONS
Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection.Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection.There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.
ADVERSE REACTIONS
The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP.
Please see Prescribing Information for BYOOVIZ (ranibizumab-nuna) HERE.
About OPUVIZ (aflibercept-yszy)
OPUVIZ (aflibercept-yszy) injection, for intravitreal use.OPUVIZ (aflibercept-yszy) is biosimilar to EYLEA (aflibercept).OPUVIZ is a vascular endothelial growth factor (VEGF) inhibitor, indicated for the treatment of patients with:Neovascular (Wet) Age-Related Macular Degeneration (AMD)Macular Edema Following Retinal Vein Occlusion (RVO)Diabetic Macular Edema (DME)Diabetic Retinopathy (DR)
Select Important Safety Information
WARNING AND PRECAUTIONS
Endophthalmitis, 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.
Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.
There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.
ADVERSE REACTIONS
The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.
Please see Prescribing Information for OPUVIZ (aflibercept-yszy) HERE.
About Harrow
Harrow, 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.
Forward-Looking Statements
This 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.
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20250717236374/en/
Contacts
Investors:Mike Biega, VP of Investor Relations and Communicationsmbiega@harrowinc.com 617-913-8890Media: Silvana Guerci-Lena, Powers & Co.silvana@powers-co.com 508-808-8993
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
3 minutes ago
- Yahoo
Kleiner Perkins is having a very good week
Even while the tech industry is still fanning its face over Figma's hot IPO on Thursday, another significant tech IPO occurred this week: Ambiq Micro. On Wednesday, the chip maker for wearable devices saw its shares climb from the initial price of $24 to over $42 on Friday. There's one thing both companies have in common: Kleiner Perkins was a major investor. So it's been a very good week for the venerable venture firm. Just for fun, we've calculated the value of Kleiner Perkins' stake in each company. Kleiner sold 1,346,499 shares of Figma at the IPO price of $33, Figma disclosed, and could have sold as many as 2,756,020 shares at that price if the bankers exercised their option to nab additional shares. Given how much demand outstripped supply for shares of Figma, we're going to assume the bankers will snap up the full tranche (or they already have). Meanwhile, Kleiner still holds 52,364,374 shares of Figma, the company says. Share prices are still fluctuating wildly in heavy trading on Day 2, from about $110 to over $142, but closed Day 1 at $115, so we'll use that number. For Figma: An estimated $91 million returned from share sales and a remaining stake worth more than $6 billion (2,756,02 shares at $33 = $90,948,660, and 52,364,374 shares at $115 = $6,021,903,010). For perspective, this stake in Figma alone is worth 3x the last mega-funds the firm raised, which was $2 billion across two vehicles in 2024. By the way, the Kleiner partner who oversaw its investment was Figma board member Mamoon Hamid. Ambiq is a much smaller company and it was a much smaller IPO. It sold a total of 4 million shares and raised $96 million for itself in its IPO. Existing shareholders are subject to the classic 180 days lockup before they can sell. Kleiner holds 2,081,831 shares, the company disclosed. Shares are still trading at a premium to the IPO price as of Friday and closed Thursday at $43.85. So we'll use that price. Ambiq stake: $91.3 million (2,081,831 at $43.85 = $91,288,289). But wait! There's more. Kleiner is also having a good month and possibly year (Kleiner has declined comment for this story). The firm reportedly scored a decent return earlier this month as part of Google's deal to license tech from Windsurf and hire away its top talent. We don't know exactly how much of the $1.1 billion or so VCs obtained from the Windsurf deal went to Kleiner specifically. But TechCrunch's Marina Temkin reports the total return was about 3x the original funding. And at least one more Kleiner-backed company is waiting in the wings to IPO. Fleet tracking startup Motive Technologies raised $150 million led by Kleiner Perkins, with Ilya Fushman joining the board, the company announced this week. Bloomberg reported in December that Motive is gearing up for an IPO, potentially still in 2025. Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
3 minutes ago
- Yahoo
Want to Get Rich? Mark Cuban Says To Save '6 Months Of Income' — Here's How Some Homeowners Are Using Real Estate To Make It Happen
Benzinga and Yahoo Finance LLC may earn commission or revenue on some items through the links below. Mark Cuban didn't get rich clipping coupons or stockpiling airline miles. His advice? Keep your junker car, avoid credit cards like the plague, and save up six months of income — not because it sounds good in a finance blog, but because life happens. "If you don't like your job at some point or you get fired or you have to move or something goes wrong," Cuban said in a Vanity Fair video, "you're going to need at least six months' income." But for many Americans, that kind of cash cushion feels more like a pipe dream than a practical step. In fact, most adults in the U.S. don't even have $1,000 saved, according to a Bankrate survey. Still, Cuban's "get rich advice" isn't just for aspiring billionaires — it's a survival-level strategy in a shaky economy. Don't Miss: Accredited Investors: Grab Pre-IPO Shares of the AI Company Powering Hasbro, Sephora & MGM— 'Scrolling To UBI' — Deloitte's #1 fastest-growing software company allows users to earn money on their phones. Cash is King — But Where Do You Find It? Even people who've been steadily employed for years often feel "house rich, cash poor." They've got equity tied up in their homes but little flexibility when an emergency hits. That's where some are getting creative — unlocking liquidity from real estate without selling their homes or taking on new debt. Enter platforms like EquityMultiple, which offer a modern way to put money to work through passive commercial real estate investing. These platforms allow investors to earn cash flow from real estate without becoming landlords — while still keeping their own home intact and their equity untouched. Think of it as making your money multitask: while your primary residence appreciates quietly in the background, your real estate investments can generate monthly income and diversify your savings. Trending: $100k+ in investable assets? – no cost, no obligation. Toothpaste and Tenants — Cuban's All About ROI Cuban's approach to building wealth might involve investing in mutual funds or even tossing a little into Bitcoin — if you're feeling bold — but the underlying theme is always the same: maximize return, minimize regret. "It's so hard to make a return on regular investments... you're better off, when you see a sale, [buying in bulk]," he said in the same Vanity Fair video. "That's an immediate return on your money." That logic — stretching your dollars with purpose — is why more investors are shifting toward income-generating alternatives like real estate-backed offerings. Instead of letting money sit in savings accounts losing value to inflation, they're deploying it in vetted property deals that pay out on a regular basis.A Modern Path To The Six-Month Safety Net Most people aren't hitting Cuban's six-month cash goal overnight. But that doesn't mean it's out of reach. It just requires some strategy — and maybe a shift in how you think about savings. Start small: rework your budget, look for dead weight in subscriptions, and automate deposits to a high-yield savings account. Then, once you've got your emergency fund foundation set, diversifying into passive real estate could help build the next layer — with monthly income that can go right back into your cash cushion or be reinvested for growth. Because, as Cuban says, "the one thing you can control in life is your effort." And putting your money in the right place? That counts, too. Read Next: With Point, you can Image: Shutterstock This article Want to Get Rich? Mark Cuban Says To Save '6 Months Of Income' — Here's How Some Homeowners Are Using Real Estate To Make It Happen originally appeared on Sign in to access your portfolio
Yahoo
3 minutes ago
- Yahoo
'Bachelor' couple says it's 'hard to watch the Ozempic craze'
Catherine and Sean Lowe emphasized there is a "healthier route" than Ozempic while speaking to Fox News Digital about their healthy habits.
