Harrow secures US rights to new ophthalmic steroid BYQLOVI

NASHVILLE, Tenn. & TAIPEI, Taiwan - Harrow (NASDAQ:HROW), a prominent North American eyecare pharmaceutical firm, has acquired exclusive commercial rights in the United States for BYQLOVI™ (clobetasol propionate ophthalmic suspension) 0.05% from Taiwan’s Formosa Pharmaceuticals. BYQLOVI, recently approved by the FDA, marks the introduction of the first new ophthalmic steroid in its class in over 15 years and is slated for availability in the fourth quarter of 2025.

BYQLOVI is designed to treat post-operative inflammation and pain following ocular surgery. The licensing agreement with Formosa Pharmaceuticals allows Harrow to leverage its presence in the U.S. eyecare market, which currently sees over 7 million ophthalmic surgeries annually. According to InvestingPro data, while Harrow maintains strong liquidity with current assets exceeding short-term obligations by nearly 3x, the company is yet to achieve profitability in the last twelve months.

The topical corticosteroid, formulated using Formosa’s proprietary APNT® nanoparticle technology, offers a uniform suspension for consistent dosing. Clinical studies have demonstrated its efficacy, with a majority of patients reporting no pain post-surgery and a significant percentage showing clear signs of inflammation reduction. Moreover, BYQLOVI has been associated with a low incidence of elevated intraocular pressure, a common side effect of ophthalmic steroids.

Harrow’s CEO, Mark L. Baum, expressed enthusiasm about introducing BYQLOVI to the U.S. market, emphasizing its potential to transform post-surgical care in ophthalmology. Erick Co, President and CEO of Formosa Pharmaceuticals, also remarked on the alignment of both companies’ commitment to improving patient outcomes, and his confidence in Harrow’s ability to ensure the successful adoption of BYQLOVI by healthcare professionals.

While BYQLOVI has shown promising results, the press release also outlines important safety information. It is contraindicated in certain viral diseases of the eye and in mycobacterial and fungal infections of ocular structures. Prolonged use of corticosteroids like BYQLOVI may result in complications such as glaucoma, cataracts, and delayed healing. Healthcare providers are advised to monitor patients for these potential adverse effects.

This announcement is based on a press release statement and contains forward-looking statements subject to risks and uncertainties. As with any new pharmaceutical product, the actual results and the successful commercialization of BYQLOVI may vary. Investors can access detailed financial analysis and additional ProTips through InvestingPro, with the company’s next earnings report scheduled for June 9, 2025. Get exclusive access to comprehensive financial metrics and expert insights to make informed investment decisions.

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