Harrow's VEVYE Shows Results for Dry Eye Disease in ESSENCE-2 Study

Harrow (NASDAQ:HROW), a leading North American eyecare pharmaceutical company, is pleased to announce results from its ESSENCE‑2 open-label extension (OLE) clinical study for VEVYE® (cyclosporine ophthalmic solution) 0.1%, the first and only cyclosporine to treat the signs and symptoms of dry eye disease (DED). 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. The one-year study results, published in Cornea, demonstrated VEVYE's sustained safety and efficacy in treating the signs and symptoms of DED, underscoring its value in managing this chronic condition. Key findings include:

• Statistically significant improvements in all prespecified efficacy endpoints compared with baseline at each visit.
• 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 6 patients (3.0%). One patient withdrew during the 52-week study due to an ocular adverse event (mild burning/stinging).
• 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 conclude that water-free cyclosporine 0.1% ophthalmic solution was safe and well tolerated during long-term use.