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Prescribing Information
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References

  1. VEVYE® (cyclosporine ophthalmic solution) 0.1% [package insert], Harrow IP, LLC; 2024.
  2. Restasis® (cyclosporine ophthalmic emulsion) 0.05% [package insert]. Allergan, LLC; 2024.
  3. Cequa® (cyclosporine ophthalmic solution) .09% [package insert]. Sun Ophthalmics, LLC; 2024.
  4. Data on file.
  5. Sheppard et al., Water-free 0.1% Cyclosporine A Solution for Treatment of Dry Eye Disease: Results of the Randomized Phase 2B/3 ESSENCE Study. Cornea 2021;00:1–8.
  6. Akpek et al., Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease The ESSENCE-2 Randomized Clinical Trial. JAMA Ophthalmol. doi:10.1001/jamaophthalmol.2023.0709. April 6, 2023.
  7. Akpek, Esen K. MD; Sheppard, John D. MD; Hamm, Adam PhD; Angstmann-Mehr, Simone; Krösser, Sonja PhD. Efficacy of a new water-free topical cyclosporine 0.1% solution for optimizing the ocular surface in patients with dry eye and cataract. Journal of Cataract & Refractive Surgery 50(6):p 644-650, June 2024.
  8. P. Agarwal, D. Khun, S. Krösser, K. Eickhoff, F.S. Wells, G.R. Willmott, et al., Preclinical studies evaluating the effect of semifluorinated alkanes on ocular surface and tear fluid dynamics, Ocul Surf. 17 (2019) 241–249.
  9. Agarwal P, Scherer D, Günther B, Rupenthal ID. Semifluorinated alkane based systems for enhanced corneal penetration of poorly soluble drugs. Int J Pharm. 2018 Mar 1;538(1-2):119-129. doi: 10.1016/j.ijpharm.2018.01.019. Epub 2018 Jan 12. PMID: 29339249.

INDICATION AND USAGE

VEVYE® (cyclosporine ophthalmic solution) 0.1% is indicated for the treatment of the signs and symptoms of dry eye disease.

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.