Harrow Acquires US Commercial Rights to Byqlovi for Postoperative Inflammation and Pain

Harrow and Taiwan-based Formosa Pharmaceuticals announced a licensing agreement in which Harrow has acquired the exclusive US commercial rights for Byqlovi (clobetasol propionate ophthalmic suspension) 0.05%.

Financial terms of the deal were not disclosed. 

Byqlovi was approved by the FDA in March 2024 for the treatment of postoperative inflammation and pain following ocular surgery as the first new ophthalmic steroid in its class in over 15 years. Eyenovia acquired the US commercial rights to clobetasol propionate ophthalmic suspension 0.05% from Formosa in August 2023. However, Formosa's agreement with Eyenovia was terminated immediately before its new deal with Harrow. 

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," Mark L. Baum, Chief Executive Officer of Harrow, said in a company news release. "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."

Byqlovi, a high-potency ophthalmic corticosteroid formulated using Formosa's proprietary APNT nanoparticle formulation technology, is designed to deliver a uniform suspension that minimizes particle setting and provides consistent dosing. 

According to Harrow, 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
• Safety benefits: with only 1.4% of patients experiencing elevated 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