For patients who may benefit from a preservative-free treatment, ZOLYMBUS™ demonstrated IOP reduction consistent with PGA expectations in a US Phase III study.1-3


For US Healthcare Professionals only | Patients & Caregivers | Full Prescribing Information | Important Safety Information
For patients who may benefit from a preservative-free treatment, ZOLYMBUS™ demonstrated IOP reduction consistent with PGA expectations in a US Phase III study.1-3
US PHASE III STUDY


US Phase III study methodology: Prospective, multicenter, randomized, investigator-masked Phase III non-inferiority trial in 464 patients with OAG or OHT comparing preservative-free bimatoprost 0.01% gel with bimatoprost 0.01% over 12 weeks. Following a washout period of up to 7 weeks depending on prior therapy, IOP was measured at 8 AM, 10 AM, and 4 PM at baseline and Weeks 2, 6, and 12; safety and tolerability were assessed throughout.2
ZOLYMBUS™ (bimatoprost ophthalmic gel) 0.01%, is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Known hypersensitivity to bimatoprost or any other ingredients in this product.
Bimatoprost may cause changes to pigmented tissues. Most frequently reported changes are increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as bimatoprost is administered. Iris pigmentation is likely to be permanent. Eyelid skin darkening and eyelash changes may be reversible.
Bimatoprost may cause gradual change to eyelashes including increased length, thickness, and number of lashes. These changes are usually reversible upon discontinuation of treatment.
Prostaglandin analogs, including bimatoprost, have been reported to cause intraocular inflammation. ZOLYMBUS should be used with caution in patients with active intraocular inflammation (e.g., iritis/uveitis) because inflammation may be exacerbated.
Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic products. ZOLYMBUS should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
Contact lenses should be removed prior to the administration of ZOLYMBUS and may be reinserted 15 minutes after administration.
Most common adverse reactions (≥10%) are conjunctival hyperemia (14%) and eye irritation (11%).
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References: 1. ZOLYMBUS [prescribing information]. Thea Pharma Inc; 2025. 2. Miller-Ellis E, Peace JH, Day DG, et al. Safety and efficacy of a preservative-free bimatoprost 0.01% ophthalmic gel: results from a phase III controlled trial. J Glaucoma. 2025;34(11):880-887. 3. Primary Open-Angle Glaucoma PPP 2020. American Academy of Ophthalmology. Published November 13, 2020. Accessed May 22, 2026. https://www. aaojournal.org/action/showPdf?pii=S0161-6420%2820%2931024-1. 4. Thea data on file. 2022. Module 2.7.3 Summary of Clinical Efficacy.
ZOLYMBUS™ (bimatoprost ophthalmic gel) 0.01%, is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Known hypersensitivity to bimatoprost or any other ingredients in this product.