Harrow Acquires U.S. Commercial Rights to Byqlovi for Treating Postoperative Inflammation and Pain

Harrow, a U.S.-based ophthalmic pharmaceutical company, has entered into a licensing agreement with Taiwan-based Formosa Pharmaceuticals to acquire the exclusive U.S. commercial rights to Byqlovi (clobetasol propionate ophthalmic suspension) 0.05%. The deal marks a significant addition to Harrow’s expanding portfolio of postoperative ophthalmic care products. Financial terms of the agreement were not disclosed.

FDA Approval and Market Introduction Timeline

Byqlovi was approved by the U.S. Food and Drug Administration (FDA) in March 2024 for the treatment of postoperative inflammation and pain following ocular surgery. Notably, it is the first new ophthalmic steroid in its class in over 15 years. Harrow plans to launch Byqlovi in the fourth quarter of 2025, targeting a market that now exceeds 7 million ophthalmic surgeries annually in the U.S.

Clinical Differentiation and Executive Commentary

Mark L. Baum, Chief Executive Officer of Harrow, highlighted the strategic importance of the acquisition, stating:

“We 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. 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.”

Formulation and Technology Platform

Byqlovi is a high-potency ophthalmic corticosteroid developed using Formosa’s proprietary APNT (Advanced Particle Nanotechnology) formulation technology. This technology enables a uniform suspension, helping to minimize particle settling and ensure consistent dosing throughout the course of treatment.

Key Efficacy and Safety Data from Clinical Studies

According to Harrow, the results from pivotal clinical studies demonstrate the following benefits of Byqlovi:

       • Pain Relief:

               • 77% and 85% of patients reported no pain at Day 4 post-surgery

               • 82% and 87% of patients reported no pain at Day 8 post-surgery

       • Inflammation Clearance:

               • 33% and 30% of patients had zero cell counts in the anterior chamber by Day 8

       • Safety Profile:

              • Only 1.4% of patients experienced elevated intraocular pressure (IOP), a substantially lower rate than with other ophthalmic steroids

       • Patient-Friendly Dosing:

               • 1 drop BID for 14 days, with no loading dose or maintenance phase required