Long-term use of Vevye safe, efficacious for treatment of dry eye disease
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Key takeaways:
- Patients demonstrated improvement in all efficacy endpoints compared with baseline.
- Fifty-five patients experienced ocular treatment-emergent adverse events, most commonly mild instillation site pain.
Vevye, a nonpreserved cyclosporine 0.1% ophthalmic solution, demonstrated sustained safety and efficacy among patients with dry eye disease, according to 52-week ESSENCE-2 open-label extension study results published in Cornea.
“The OLE data affirms why Vevye is such a special product and why so many patients are now entering their sixth refill cycle,” Mark L. Baum, chairman and CEO of manufacturer Harrow, said in a related company press release. “Vevye’s unique value is enabled because of its patented water-free formulation, which catalyzes additional product features and related clinical benefits.”
The phase 3, prospective, multicenter, open-label study enrolled 202 patients with dry eye disease from the ESSENCE-2 study, all of whom administered a single drop of Vevye (cyclosporine ophthalmic solution, Harrow) twice daily in each eye for 52 weeks. The primary endpoints were ocular and nonocular adverse events, while secondary outcomes included visual acuity, biomicroscopy, IOP and dilated fundoscopy.
Of 175 patients who completed the study, 55 (27.5%) reported 74 ocular treatment-emergent adverse events, the most common of which was mild instillation site pain (6.5%). Seven serious adverse events occurred during the study, but were nonocular, assessed as unrelated and resolved by the end of the study period.
“We know that tolerability is a major issue with long-term immunomodulatory medications, leading to poor patient compliance and dropout,” Laura M. Periman, MD, director of dry eye services and clinical research at Periman Eye Institute, said in the release. “In this 52-week study, perhaps the most impressive data point was that only one patient stopped using Vevye because of an ocular adverse event, which was mild burning and stinging.”
In addition, participants demonstrated statistically significant improvement in all efficacy endpoints compared with baseline, with corneal staining improving early and stabilizing over time, according to study results. Tear production improved continuously, and symptomology improved after 1 year of treatment.
“Topical cyclosporine has established a remarkable decades-long efficacy and safety profile,” John D. Sheppard, MD, study investigator and president of Virginia Eye Consultants, said in the release. “Finally, we have the right vehicle.”
Reference:
- Harrow announces 52-week data from Vevye ESSENCE-2 open-label extension study. https://investors.harrow.com/news-releases/news-release-details/harrow-announces-52-week-data-vevyer-essence-2-open-label. Published June 5, 2024. Accessed June 5, 2024.
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