Core Insights - Harrow has acquired exclusive U.S. commercial rights for BYQLOVI™, a new ophthalmic steroid approved by the FDA for post-operative inflammation and pain, marking a significant advancement in the eyecare pharmaceutical market [1][2] Company Overview - Harrow is a leading North American eyecare pharmaceutical company focused on innovative ophthalmic products, aiming to enhance patient access and outcomes [16] - Formosa Pharmaceuticals is a clinical stage biotechnology company specializing in ophthalmology and oncology, utilizing proprietary nanoparticle formulation technology to improve drug delivery [15] Product Details - BYQLOVI™ (clobetasol propionate ophthalmic suspension) 0.05% is indicated for treating post-operative inflammation and pain following ocular surgery [5] - The product is expected to be available in the U.S. market in the fourth quarter of 2025 [1] Clinical Efficacy - Clinical studies show that 77% to 85% of patients reported no pain at Day 4 post-surgery, and 82% to 87% reported no pain at Day 8 post-surgery, indicating strong pain relief [3] - Inflammation clearance was also notable, with 33% and 30% of patients showing zero cell counts in the anterior chamber at Day 8 post-surgery [3] Safety Profile - Only 1.4% of patients experienced elevated intraocular pressure (IOP), significantly lower than other ophthalmic steroids, suggesting a favorable safety profile [4] - The dosing regimen is user-friendly, requiring only 1 drop twice daily for 14 days without a loading dose [4] Market Potential - The U.S. market for ophthalmic surgeries exceeds 7 million annually, presenting a substantial opportunity for BYQLOVI to capture market share in the multi-billion-dollar post-surgical care segment [2]
Harrow Acquires U.S. Commercial Rights to BYQLOVI™ (Clobetasol Propionate Ophthalmic Suspension) 0.05% from Formosa Pharmaceuticals