Formosa Pharmaceuticals grants Harrow commercial rights in US to clobetasol propionate ophthalmic suspension 0.05% (BYQLOVI), terminates deal with Eyenovia

Harrow has acquired the exclusive US commercial rights to clobetasol propionate ophthalmic suspension 0.05% (BYQLOVI) from Formosa Pharmaceuticals.¹

BYQLOVI was approved by the FDA in March 2024² for the relief of pain and inflammation following ocular surgery. At the time of FDA approval, exclusive US commercial rights were held by Eyenovia, which the company received in 2023.³

However, with the new deal with Harrow, Formosa has terminated the agreement with Eyenovia due to “suspended sales of BYQLOVI due to corporate setbacks related to other programs.”¹

According to a news release from Formosa, Harrow expects BYQLOVI to be commercially available in the fourth quarter of 2025.

Mark L. Baum, CEO of Harrow, commented on the partnership, saying, “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. With compelling efficacy, extraordinary safety, and patient-friendly dosing, BYQLOVI has the potential to shift the paradigm in the multi–billion-dollar US postsurgical care ophthalmic segment.”

Erick Co, president and CEO of Formosa Pharmaceuticals, commented on the new partnership with Harrow, stating, “Harrow’s commitment to innovation, patient access, and physician engagement closely aligns with our mission to promote unique clinical advancements that improve patient outcomes. We are confident that Harrow’s leadership in the US eye care space will ensure BYQLOVI’s successful adoption among surgeons and eye care professionals—and ultimately, better postsurgical experiences for US patients.”

BYQLOVI is a high-potency ophthalmic corticosteroid formulated using Formosa’s proprietary APNT nanoparticle formulation technology that delivers a highly uniform suspension, minimizing particle setting and providing consistent dosing.

References:

1. Harrow acquires US commercial rights to BYQLOVI (clobetasol propionate ophthalmic suspension) 0.05% from Formosa Pharmaceuticals. Formosa Pharmaceuticals. June 9, 2025. Accessed June 12, 2025. https://www.formosapharma.com/harrow-acquires-u-s-commercial-rights-to-byqlovi-clobetasol-propionate-ophthalmic-nanosuspension-0-05-from-formosa-pharmaceuticals/

2. Hutton D. FDA approves Eyenovia’s APP13007 for relief of pain, inflammation after surgery. March 5, 2024. Accessed June 12, 2025. https://www.ophthalmologytimes.com/view/fda-approves-eyenovia-s-app13007-for-relief-of-pain-inflammation-after-surgery

3. Hutton D. Eyenovia acquires US commercial rights to APP13007 from Formosa Pharmaceuticals. August 16, 2023. Accessed June 12, 2025. https://www.ophthalmologytimes.com/view/eyenovia-acquires-us-commercial-rights-to-app13007-from-formosa-pharmaceuticals