Harrow and Formosa Pharmaceuticals 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 postoperative inflammation and pain following ocular surgery and is the first new ophthalmic steroid in its class in over 15 years, Harrow said in a press release. Harrow said it expects Byqlovi to be available in the fourth quarter of 2025.

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 postoperative inflammation and pain, the press release stated.

According to Harrow and Formosa, key highlights of Byqlovi include:

• 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, 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.