Harrow announced the results from its Phase 3 ESSENCE 2 open-label extension (OLE) clinical study for VEVYE (cyclosporine ophthalmic solution) 0.1%, the first cyclosporine to treat the signs and symptoms of dry eye disease. The one-year study results, published in Cornea, demonstrated statistically significant improvements in all prespecified efficacy endpoints compared with baseline at each visit, the company stated in a press release. 

Additionally, corneal staining improvements were early and stabilized over time while tear production improved continuously and symptomatology improvement followed these effects. The most common ocular treatment-related adverse events were mild instillation site pain in 13 patients (6.5%) and reduced visual acuity in six patients (3.0%) — one patient withdrew during the 52-week study due to an ocular adverse event (mild burning/stinging). 

The study also found that on a 0 to 10 scale (the higher the number equating to a better rating), when patients were asked to rate the question, “How satisfied are you with the study eye drop?”— 33.1% of patients provided the highest possible rating of 10. Approximately 91% of patients rated a score of 5 or higher, indicating satisfaction with the treatment.

Investigators concluded that water-free cyclosporine 0.1% ophthalmic solution was safe and well tolerated during long-term use.

ESSENCE-2 OLE was a Phase 3, prospective, multicenter, open-label, clinical study with 202 patients, who had previously completed the ESSENCE 2 study, receiving VEVYE in each eye twice a day for 52 weeks.