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INDICATION

ZOLYMBUS™ (bimatoprost ophthalmic gel) 0.01% is a prescription eye gel used to lower the pressure in the eye (intraocular pressure) in people with open-angle glaucoma or ocular hypertension when their eye pressure is too high. ZOLYMBUS belongs to a group of medicines called prostaglandin analogs.

ZOLYMBUS is not recommended in children younger than 16 years of age because of the potential for eye and eyelid color changes.

IMPORTANT SAFETY INFORMATION

Do not use ZOLYMBUS if you are allergic to bimatoprost or any of the ingredients in ZOLYMBUS.

ZOLYMBUS may slowly cause darkening of the eye color, darkening of the eyelid and eyelashes, or increased growth and thickness of eyelashes. Color changes may increase for the length of time that ZOLYMBUS is administered, and eye color changes are likely to be permanent.

Tell your doctor immediately about any change in your eye, if an eye condition develops, about any sudden change in your vision, if any eye side effects occur, or if you have previously had or are planning to have eye surgery.

Contact lenses should be removed prior to the administration of ZOLYMBUS and may be reinserted 15 minutes after administration.

If you are using other eye drops in addition to ZOLYMBUS, wait 5 minutes between using each type of eye drop.

If one dose is missed, treatment should continue with the next dose as normal.

ADVERSE REACTIONS

The most common side effects of ZOLYMBUS include: redness of and around the eye (conjunctival hyperemia), eye irritation, itchy eyes (eye pruritus), dry eye, foreign body sensation in the eyes, increase of tears in the eye (increased lacrimation), eye pain, blurry vision.

These are not all the possible side effects, you may experience with ZOLYMBUS. Talk to your doctor if you have questions about side effects. To report side effects, contact Thea Pharma Inc. at 1-833-838-4028 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information here.