Study finds long-term cyclosporine ophthalmic solution is well-tolerated for dry eye disease
Results from the ESSENCE‑2 open-label extension (OLE) clinical study highlight the sustained safety and efficacy of cyclosporine ophthalmic solution 0.1% (VEVYE®) for the treatment of dry eye disease.
The phase 3, prospective, multicenter, OLE included 202 patients using cyclosporine ophthalmic solution 0.1% in each eye twice daily for 1 year.
At week 52, 175 patients (86.6%) had completed the OLE. Among these patients, 55 (27.5%) reported 74 ocular treatment-related adverse events, the most common of which was instillation site pain (6.5%).
Patients showed statistically significant improvements in all prespecified efficacy end points compared with baseline. Corneal staining improvements occurred early and stabilized over time, while tear production showed continuous improvement. Symptomatology also improved after 1 year of treatment.
“The results demonstrated sustained 1-year efficacy, in both signs and symptoms of dry eye disease, and may help understand short and long-term healing dynamics in a predominant inflammatory dry eye disease population,” the researchers concluded.
References
Harrow announces 52-week data from VEVYE® ESSENCE-2 open-label extension study. BusinessWire. June 5, 2024. Accessed June 12, 2024. https://www.businesswire.com/news/home/20240605338632/en/Harrow-Announces-52-Week-Data-from-VEVYE%C2%AE-ESSENCE-2-Open-Label-Extension-Study
Wirta DL, Galor A, Aune CA, et al. Long-term safety and efficacy of a water-free cyclosporine 0.1% ophthalmic solution for treatment of dry eye disease: ESSENCE-2 OLE. Cornea. 2024. doi:10.1097/ICO.0000000000003567
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