Prostaglandin Analog

Zolymbus

Approved 9 Sept 2025EyeGel

Indications

ZOLYMBUS™ is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ZOLYMBUS™ is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Contraindications

ZOLYMBUS is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see Adverse Reactions (6.2) ] . Hypersensitivity.

Warnings and precautions

Pigmentation : Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation is likely to be permanent. ( 5.1 ) Eyelash Changes : Gradual change to eyelashes including increased length, thickness and number of lashes. Usually, reversible. ( 5.2 )

5.1Pigmentation

Bimatoprost has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as bimatoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of bimatoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients.

Patients who receive treatment should be informed of the possibility of increased pigmentation. The long term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment.

While treatment with ZOLYMBUS can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.

5.2Eyelash Changes

ZOLYMBUS may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.

At a glance

Brand name: Zolymbus
Active substance: bimatoprost
Pharmacologic class: Prostaglandin Analog
Route: Eye
Dosage form: Gel
Applicant: Thea Pharma
Status: Prescription
FDA approval: 9 Sept 2025
Application: NDA217307-001

Indications

Warnings and precautions

5.1Pigmentation

While treatment with ZOLYMBUS can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.

5.2Eyelash Changes

Adverse reactions

The following adverse reactions are described elsewhere in the labeling: Pigmentation including blepharal pigmentation and iris hyperpigmentation [see Warnings and Precautions (5.1) ] Eyelash Changes [see Warnings and Precautions (5.2) ] Intraocular Inflammation [see Warnings and Precautions (5.3) ] Macular Edema [see Warnings and Precautions (5.4) ] Hypersensitivity [see Contraindications (4) ] Most common adverse reactions (≥10%) are conjunctival hyperemia (14%) and eye irritation (11%).

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Thea Pharma Inc. at 1-833-838-4028 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the two clinical trials conducted with ZOLYMBUS (bimatoprost ophthalmic gel) 0.01% comparing it to preserved bimatoprost ophthalmic solution 0.01%, the most frequently reported ocular adverse reactions were conjunctival hyperemia (14%), eye irritation (11%), eye pruritus (9%) and foreign body sensation in eyes (8%).

Other adverse drug reactions (reported in 1% to 6% of patients) with ZOLYMBUS in the studies included dry eye, abnormal sensation in eye, lacrimation increased, eye pain, and vision blurred.

6.2Postmarketing Experience

The following adverse reactions have been identified during post-approval use of topical bimatoprost products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to bimatoprost, or a combination of these factors include: asthma-like symptoms, dizziness, dry eye, dyspnea, eye discharge, eye edema, foreign body sensation, headache, hypersensitivity including signs and symptoms of eye allergy and allergic dermatitis, hypertension, lacrimation increased, periorbital and lid changes associated with periorbital fat atrophy leading to skin tightness, deepening of the eyelid sulcus, eyelid ptosis, enophthalmos, and eyelid retraction; and photophobia.

Zolymbus

Indications

Contraindications

Warnings and precautions

5.1Pigmentation

5.2Eyelash Changes

At a glance

Two medicines in one question?

Zolymbus

Indications

Contraindications

Warnings and precautions

5.1Pigmentation

5.2Eyelash Changes

At a glance

Two medicines in one question?

5.3Intraocular Inflammation

5.4Macular Edema

5.5Contact Lens Use

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Official product information