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Harrow Acquires U.S. Commercial Rights to BYQLOVI (Clobetasol Propionate Ophthalmic Suspension) 0.05% from Formosa Pharmaceuticals NASHVILLE, Tenn. and Taipei, Taiwan

Key Takeaway: Harrow has announced the acquisition of exclusive U.S. commercial rights for BYQLOVI, a clobetasol propionate ophthalmic suspension, from Formosa Pharmaceuticals. This product has recently received FDA approval for treating post-operative inflammation and pain following ocular surgery. BYQLOVI is being highlighted as a clinically differentiated corticosteroid with a unique nanoparticle formulation that improves dosing consistency. It is expected to be available to the U.S. market in the fourth quarter of 2025, targeting a significant market of over 7 million ophthalmic surgeries annually.

Market Sentiment Analysis

POSITIVE FACTORS

  • Harrow acquires exclusive U.S. commercial rights for BYQLOVI, enhancing its product portfolio.
  • BYQLOVI is the first new ophthalmic steroid approved in over 15 years, indicating innovation.
  • The product shows promising clinical results, with high percentages of patients reporting no pain post-surgery.
  • BYQLOVI's unique formulation could significantly improve patient outcomes in post-surgical care.

CONCERNS & RISKS

  • Prolonged use of corticosteroids may lead to increased intraocular pressure, which could result in glaucoma.
  • There are risks associated with infections due to suppressed host response from corticosteroid use.
  • Potential adverse reactions reported include eye inflammation and corneal edema in some patients.

Full Press Release Details

Acquires U.S. Commercial Rights to BYQLOVI (Clobetasol Propionate Ophthalmic Suspension) 0.05% from Formosa Pharmaceuticals
Tenn. and Taipei, Taiwan, June 9, 2025 - Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, and
Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TW), today announced a licensing agreement, whereby Harrow has acquired
the exclusive U.S. commercial rights for BYQLOVI (clobetasol propionate ophthalmic suspension) 0.05%. BYQLOVI was recently
approved by the U.S. Food and Drug Administration (FDA) for the treatment of post-operative inflammation and pain following ocular surgery
and is the first new ophthalmic steroid in its class in over 15 years. Harrow expects BYQLOVI to be available in the fourth quarter of
are thrilled to soon launch BYQLOVI, a truly clinically differentiated topical corticosteroid, into a U.S. market that now exceeds 7
million annual ophthalmic surgeries," said Mark L. Baum, Chief Executive Officer of Harrow. "With compelling efficacy, extraordinary
safety, and patient-friendly dosing, BYQLOVI has the potential to shift the paradigm in the multi-billion-dollar U.S. post-surgical care
ophthalmic segment."
commitment to innovation, patient access, and physician engagement closely aligns with our mission to promote unique clinical advancements
that improve patient outcomes," said Erick Co, President and CEO of Formosa Pharmaceuticals. "We are confident that Harrow's
leadership in the U.S. eyecare space will ensure BYQLOVI's successful adoption among surgeons and eyecare professionals -
and ultimately, better post-surgical experiences for U.S. patients."
a high-potency ophthalmic corticosteroid formulated using Formosa's proprietary APNT nanoparticle formulation technology,
delivers a highly uniform suspension that minimizes particle setting and provides consistent dosing. Its pharmacologic performance
and clinical outcomes position it as a best-in-class option for post-operative inflammation and pain.
highlights of BYQLOVI include:
Pain Relief with 77% and 85%, respectively, of patients in supportive pivotal clinical studies reporting no pain at Day 4 post-surgery;
82% and 87%, respectively, reporting no pain at Day 8 post-surgery.
Inflammation Clearance with 33% and 30%, respectively, of patients in supportive pivotal clinical studies with zero cell counts
in the anterior chamber at Day 8 post-surgery.
Benefits with only 1.4% of patients experiencing elevated intraocular pressure (IOP), a substantially lower rate compared to
other ophthalmic steroids.
Post-Surgical Dosing at 1 drop BID dosing for 14 days on label; without the need for a loading dose and a maintenance phase.
Acquires U.S. Commercial Rights to BYQLOVI (Clobetasol Propionate Ophthalmic Suspension) 0.05% from Formosa Pharmaceuticals
BYQLOVI (clobetasol propionate ophthalmic suspension) 0.05%
(clobetasol propionate ophthalmic suspension) 0.05%, for topical ophthalmic use
is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
is contraindicated in most active viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic
keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
Pressure (IOP) Increase: Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual
acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or
longer, IOP should be monitored.
Prolonged use of corticosteroids may result in posterior subcapsular cataract formation.
Healing: The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
and Scleral Melting: In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use
of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination
of the patient with the aid of magnification, such as slit lamp biomicroscopy, and where appropriate, fluorescein staining.
Infections: Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections.
In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after
2 days, the patient should be reevaluated.
Infections: Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great
caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including
Infections: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application.
Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should
be taken when appropriate.
Acquires U.S. Commercial Rights to BYQLOVI (Clobetasol Propionate Ophthalmic Suspension)
0.05% from Formosa Pharmaceuticals
adverse reactions occurring in 1% of subjects in clinical studies who received BYQLOVI included eye inflammation (2%), corneal edema
(2%), anterior chamber inflammation (2%), cystoid macular edema (2%), intraocular pressure elevation (1%), photophobia (1%) and vitreous
detachment (1%). Many of these reactions may have been the consequence of the surgical procedure.
IN SPECIAL POPULATIONS
There are no adequate and well-controlled studies of BYQLOVI administration in pregnant women to inform a drug-associated risk.
additional information about BYQLOVI , please see the Full Prescribing Information.
Formosa Pharmaceuticals
Pharmaceuticals, Inc. (6838.TW) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology.
The company's proprietary nanoparticle formulation technology (APNT ), through which BYQLOVI was developed, improves the dissolution
and bioavailability of APIs for topical, oral, and inhaler administration. Resulting formulations have high uniformity, purity, and stability,
thereby allowing the utilization of poorly soluble or extremely potent drug agents which otherwise may face insurmountable challenges
in safety, delivery, and penetration to target tissues. For more details about Formosa Pharma and APNT , visit www.formosapharma.com.
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.
Acquires U.S. Commercial Rights to BYQLOVI (Clobetasol Propionate Ophthalmic Suspension)
0.05% from Formosa Pharmaceuticals
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, 2023, 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.
Contacts:
For Harrow, Inc.: For Formosa Pharmaceuticals:
Jamie Webb Wayne Wei, MPH, CLP, RAC
Director of Communications and Investor Relations Chief Strategy & Business Officer
jwebb@harrowinc.com waynewei@formosapharma.com
615-733-4737

Frequently Asked Questions

What is BYQLOVI used for?

BYQLOVI treats post-operative inflammation and pain after ocular surgery.

Who acquired BYQLOVI's U.S. commercial rights?

Harrow acquired the exclusive U.S. commercial rights to BYQLOVI.

What condition does BYQLOVI address?

BYQLOVI addresses inflammation and pain following ocular surgery.

How is BYQLOVI administered?

BYQLOVI is administered as 1 drop, twice daily for 14 days.

What are common side effects of BYQLOVI?

Common side effects include eye inflammation, corneal edema, and photophobia.

Last updated: Jun 9, 2025