Thea Pharma, Inc.’s ZOLYMBUS (bimatoprost ophthalmic gel) 0.01% has officially launched to the U.S. market as a preservative-free (PF) gel formulation for glaucoma management.
This new addition is making its debut during this week’s American Optometric Association (AOA) Optometry’s Meeting in Phoenix, Arizona.
How exciting! Where should we start?
Quick recap on Thea Pharma: This is the U.S. subsidiary of Laboratoires Théa, a European pharmaceutical company specializing in the research, development, and commercialization of ophthalmic products available across 75 countries.
Check out our past coverage—which includes the 2023 commercial launch of IYUZEH (latanoprost ophthalmic solution) 0.005%, another PF option for glaucoma management.
And read up on the company’s PF-based product focus.
Now to ZOLYMBUS.
The basics: This is a prostaglandin analog (PA) indicated to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Side note: If you're not familiar with bimatoprost, click here for a rundown on its U.S. regulatory history and mechanism of action (MOA).
Talk more about this formulation.
ZOLYMBUS features a patented mucoadhesive lubricating gel technology designed to increase contact time on the ocular surface.
What this does: Support penetration and drug delivery (but without benzalkonium chloride [BAK]).
Got it. So, when was it granted FDA approval?
September 2025.
Check out this letter confirming its new drug application (NDA) approval from the federal agency.
Let’s talk dosing and administration.
Per ZOLYMBUS’s prescribing information (PI):
- One drop should be administered in the affected eye(s) once daily in the evening.
As for its dosing strength: The ophthalmic gel of 0.01% bimatoprost is packaged in a single-dose container.
Also important: Contact lens wearers are advised to remove lenses prior to administering the formulation and wait at least 15 minutes before reinserting.
Next up: contraindications, warnings, and precautions.
The PI notes just one contraindication: patients with a hypersensitivity to bimatoprost or any of the ophthalmic gel’s ingredients.
As for warnings and precautions, we’ll focus on two:
- Pigmentation of the iris (likely to be permanent) or of the periorbital tissue (eyelid) and eyelashes
- Gradual eyelash changes, which may include increased length, thickness, and number of lashes (typically reversible)
Others include active intraocular inflammation (iritis / uveitis) and macular edema (such as cystoid macular edema).
Caution is advised for aphakic patients and pseudophakic patients with a torn posterior lens capsule.
How about associated adverse reactions?
The most common (occurring in ≥10%): Conjunctival hyperemia (14%) and eye irritation (11%)
- See here for more (scroll to Section 6).
The basis for these reactions: Two clinical trials conducted with ZOLYMBUS in comparison to preserved bimatoprost ophthalmic solution 0.01%
Any post-marketing reactions to report?
Definitely a few … and keep in mind, these are based on voluntary reporting from users:
- Asthma-like symptoms, dizziness, dry eye, dyspnea, eye discharge, eye edema, foreign body sensation, headache, hypersensitivity (such as signs and symptoms of eye allergy and allergic dermatitis)
For the full list, see here (and scroll to Section 6.2).
Alrighty, now to accessibility and affordability options.
Thea is offering patients options for home delivery (via PhilRx) or pickup at a local pharmacy.
Check out pricing via its copay program (for eligible patients with commercial insurance).
And see here for prescriptions conducted through an eyecare provider office.
And if I have more questions?
For optometrists attending Optometry’s Meeting this week (June 17-20), stop by the Thea booth (#1522).
Otherwise, reach out to the company directly.