Harrow, a leading North American eyecare pharmaceutical company, and Taiwan-based Formosa Pharmaceuticals (Formosa), announced a licensing agreement, whereby Harrow has acquired the exclusive US commercial rights for Byqlovi (clobetasol propionate ophthalmic suspension) 0.05%. Byqlovi was recently approved by the US 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 2025.
“We are thrilled to soon launch Byqlovi, a truly clinically differentiated topical corticosteroid, into a US 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 US post-surgical care ophthalmic segment.”
“Harrow’s 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 US eyecare space will ensure Byqlovi’s successful adoption among surgeons and eyecare professionals – and ultimately, better post-surgical experiences for US patients.”
• Byqlovi, 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.
• Best-in-Class 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.
• Best-in-Class 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.
• Safety Benefits with only 1.4% of patients experiencing elevated intraocular pressure (IOP), a substantially lower rate compared to other ophthalmic steroids.
• Best-in-Class Post-Surgical Dosing at 1 drop BID dosing for 14 days on label; without the need for a loading dose and a maintenance phase.
• Formosa Pharmaceuticals, Inc. 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.
Harrow, Inc. is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the North American market.
Sick and tired of always wondering if you are being asked to pay the right price for your APIs? This empowers you with the answers you need to make the right decisions in the Global API market.
Chemxpert Database is one of the biggest and most comprehensive directories of pharma and chemicals, manufacturers, suppliers and information. Provided with current information on prices, demand and transactions, it gives you instant feedback on whether you are buying what is right and at the right time.
Start using market intelligence today and allow yourself to be in control in the API market.
Check it out today and make more informed sourcing decisions! Learn More!