Harrow Inc. has purchased the U.S. commercial rights to Formosa Pharmaceuticals’s BYQLOVI (clobetasol propionate ophthalmic suspension) 0.05% to treat pain and inflammation following ocular surgery.
No intro of Harrow needed, but how about a rundown on Formosa?
The Taipei City, Taiwan-based clinical stage biopharmaceutical company specializes in the ophthalmology, oncology, and anti-infective space.
Its science: Involves a proprietary nanoparticle formulation platform technology called APNT, which is designed for topical, oral, and intranasal administration.
- About this platform tech: The APNT Formulation Platform reduces particle sizes to improve dissolution and bioavailability—all with an ideally lower risk of contamination.
Next up: BYQLOVI.
What it is: A proprietary homogeneous nanosuspension with a solution-like appearance to provide eye comfort and—potentially—enhance drug penetration into ocular tissues.
- Notably: Formosa’s APNT platform is the base on which this compound was developed.
Its indication: The corticosteroid is intended for the treatment of post-operative inflammation and pain following ocular surgery.
- The dosing schedule: Twice a day (BID) for 14 days
And its regulatory history?
Originally co-developed by Formosa and Durham, North Carolina-based AimMax Therapeutix, Inc., the clobetasol suspension’s U.S. exclusive rights were purchased by Eyenovia, Inc. in August 2023.
- Fast forward to March 2024: The FDA granted approval (check out our interview with the CEO of Eyenovia).
- See its supporting clinical data.
- And in September 2024: Eyenovia announced the U.S. commercial launch of the suspension.
- Take note: Formosa still retained ownership of the product outside the U.S. (see here for a look at the licensing agreements for the suspension around the globe).
Hold up. So Eyenovia owns the U.S. rights?
As of June 9, 2025, nope. Formosa noted in its release that its new Harrow partnership "immediately followed termination" of the company's agreement with Eyenovia.
The reason: Eyenovia reportedly "suspended sales of BYQLOVI due to corporate setbacks related to other programs."
- To note: Glance reached out to both Harrow and Formosa to seek more details on this.
Another question: How is this product launching if it was already launched in 2024?
That was our understanding as well. We’ve reached out for clarification on this.
Stay tuned to hear more!
Will do. In the meantime, let’s talk about suspension efficacy.
In announcing its acquisition, Harrow highlighted a few key positive facts about BYQLOVI’s efficacy in providing ocular pain relief in supporting pivotal clinical trials, with:
- Over 75% of patients reporting no pain by Day 4 postop
- Over 80% of patients reporting no pain by Day 8 postop
See additional supporting clinical research.
Any warnings or precautions to be aware of?
A few … per its PI, prolonged use of the corticosteroid (10 days or longer) may be associated with:
- Intraocular pressure (IOP) increase
- Potential development of glaucoma with damage to the optic nerve
- Visual acuity and fields of vision defects
- Cataract development
As for adverse reactions, ocular manifestations (occurring in ≥ 1% of subjects postop) in clinical research included:
- Eye inflammation
- Corneal edema
- Anterior chamber inflammation
- Cystoid macular edema
- Photophobia
- Vitreous detachment
Important to note, however: The PI emphasized that these reactions may have been linked to the ocular surgery itself—not necessarily use of clobetasol propionate.
So what else do we know?
Per the company’s announcement, Harrow shared plans to launch its newly-named BYQLOVI at the end of the year (Q4 2025).
- Notably: BYQLOVI is reported to be the first new ophthalmic steroid in its class in 15+ years.
“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,” stated Harrow CEO Mark L. Baum.
Any comments from Formosa?
In regards to those questions we had? Not yet. However, in its announcement, the company’s President and CEO Erick Co noted Harrow’s leadership position in the U.S. eyecare space as a major potential boost for the corticosteroid.
This position, he stated, bodes well for “BYQLOVI’s successful adoption among surgeons and eyecare professionals—and ultimately, better post-surgical experiences for U.S. patients.”
Big picture: Take a look at what the company’s been up to as of late, including partnerships and product launches.