VEVYE® (cyclosporine ophthalmic solution) 0.1% was clinically tested in two Phase 3 studies totalling 738 patients. In pooled clinical studies, 56.8% of patients showed a rapid onset of treatment with 3 or more grades of improvement in total corneal fluorescein staining (tCFS) by Day 15. Over 66% of patients showed 3 or more grades of improvements by Day 29.

Over a period of 56 weeks, patients in an open label extension study showed sustained improvement in tCFS.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Potential for Eye Injury and Contamination – To avoid the potential for eye injury and/or contamination, patients should not touch the bottle tip to the eye or other surfaces.

Use with Contact Lenses – VEVYE® should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following the administration of VEVYE®.

Adverse Reactions

In clinical trials with 738 subjects receiving at least 1 dose of VEVYE®, the most common adverse reactions were instillation site reactions (8%) and temporary decreases in visual acuity (3%).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For additional information about VEVYE®, please see the Full Prescribing Information.