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Spotlight on VEVYE®

Ophthalmology 360

This Spotlight Series article is editorially independent content.

Dry eye disease (DED) continues to be one of the most common ocular surface disorders, impacting more than 16 million Americans. Inflammation and immunologic processes play a crucial role in the pathophysiology of this disorder. While several therapeutic strategies, from artificial tears to anti-inflammatory agents, are currently available for DED treatment, there is still a high unmet need for effective therapies that can provide rapid, clinically meaningful improvements to the corneal surface while remaining well tolerated.1

VEVYE®: Offering Rapid Onset

One of the newer therapies for DED is VEVYE (cyclosporine ophthalmic solution; Harrow). Approved by the US Food and Drug Administration in June 2023, it is the first and only semifluorinated alkane–dissolved cyclosporine indicated for the treatment of the signs and symptoms of DED.2,3

VEVYE combines cyclosporine 0.1% with perfluorobutylpentane, a water-free semifluorinated alkane vehicle that dissolves cyclosporine into a clear solution. The low surface tension of perfluorobutylpentane promotes immediate spreading and prolonged retention on the ocular surface. Because the formulation is water-free, it has no associated pH or osmolarity and does not require preservatives. Together, these formulation characteristics may contribute to improved bioavailability and tolerability.1,4,5

Efficacy Data

Clinical studies have demonstrated that VEVYE rapidly improves common DED symptoms, including burning, itching, and foreign body sensation, while helping maintain long-term tear film stability.1,4,5

The efficacy and safety of VEVYE were assessed in a total of 1,369 patients with DED in the 12-week ESSENCE-1 and 4-week ESSENCE-2 studies. Both were multicenter, randomized, double-masked, vehicle-controlled, phase 3 studies. The primary endpoint was change from baseline in total corneal fluorescein staining (tCFS) at day 29.1,5

In the pooled studies, 56.8% of patients achieved 3 or more grades of improvement in tCFS at day 15 (see FIGURE 1).1,5

VEVYE demonstrated sustained efficacy with continuous improvement in all measured symptoms over 12 months in the open-label extension (OLE) study. The 52-week study included 202 patients who had completed ESSENCE-2.4

By week 56, patients experienced an average 38% reduction in dryness, as measured by the Visual Analog Scale (see FIGURE 2). Furthermore, patients demonstrated an average 98% increase in tear production and an average 52% improvement in tCFS from baseline.4

Safety and Tolerability

VEVYE was well tolerated in clinical studies of 738 patients receiving at least 1 dose of the study drug, with 8% experiencing instillation site reactions and 3% reporting a temporary decrease in visual acuity. In pooled data, 99.8% of patients experienced no or mild instillation-site pain. Across the 3 studies, VEVYE had no reports of severe instillation site pain.1,3-5 In the OLE study, 1 patient discontinued treatment due to an ocular adverse event.4

Dosing and Administration

The recommended dose is 1 drop twice daily in each eye every 12 hours. VEVYE should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration. Lenses may be reinserted 15 minutes following instillation.3

For more information, visit https://vevye.com/hcp.

References

  1. Akpek EK, Wirta DL, Downing JE, 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. 2023;141(5):459-466. doi:10.1001/jamaophthalmol.2023.0709
  2. Harrow announces availability of VEVYE® (cyclosporine ophthalmic solution) 0.1%, the first and only cyclosporine-based product indicated for treating both signs and symptoms of dry eye disease. News release. Harrow. January 11, 2024. Accessed June 29, 2026. https://www.harrow.com/news-releases/news-release-details/harrow-announces-availability-vevyer-cyclosporine-ophthalmic
  3. VEVYE. Package insert. Harrow IP, LLC; 2025.
  4. Akpek EK, Sheppard JD, Hamm A, Angstmann-Mehr S, Krösser S. Efficacy of a new water-free topical cyclosporine 0.1% solution for optimizing the ocular surface in patients with dry eye and cataract. J Cataract Refract Surg. 2024;50(6):644-650. doi:10.1097/j.jcrs.0000000000001423
  5. Sheppard JD, Wirta DL, McLaurin E, et al. A water-free 0.1%cyclosporine A solution for treatment of dry eye disease: results of the randomized phase 2B/3 ESSENCE study. Cornea. 2021;40(10):1290-1297. doi:10.1097/ICO.0000000000002633

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