Harrow announced results from its ESSENCE‑2 open-label extension (OLE) clinical study for VEVY® (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.
Dr. John D. Sheppard, ophthalmologist, president of Virginia Eye Consultants, and one of the investigators on the ESSENCE‑2 OLE study, stated, “Topical cyclosporine has established a remarkable decades-long efficacy and safety profile. Finally, we have the right vehicle.”
Dr. Laura M. Periman, ophthalmologist and director of Dry Eye Services and Clinical Research at Periman Eye Institute, added, “We know that tolerability is a major issue with long-term immunomodulatory medications leading to poor patient compliance and dropout. 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. Also, patients randomized to VEVYE in ESSENCE-2 that continued into the OLE, on average, saw their natural tear production nearly double after 56 weeks of treatment from baseline. Furthermore, these patients saw a statistically significant improvement in all measured symptoms at all measured time points compared to baseline. ESSENCE-2 OLE data demonstrates the long-term potential of VEVYE for patients suffering from chronic dry eye disease.”
Mark L. Baum, chairman and CEO of Harrow, said, “The OLE data affirms why VEVYE is such a special product and why so many patients are now entering their sixth refill cycle. VEVYE’s unique value is enabled because of its patented water-free formulation, which catalyzes additional product features and related clinical benefits1: VEVYE is preservative-free, has no pH or osmolarity, and requires only twice‑daily dosing with an individual dosage that is 1/10th the size of conventional eye drops. In addition, in a pre-clinical ex-vivo corneal penetration study2, VEVYE’s semi-fluorinated alkane vehicle, perfluorobutylpentane (PFBP), delivered approximately 22 times more cyclosporine into the cornea compared to RESTASIS®. This OLE data supports our efforts to make sure eyecare professionals and their patients are aware of how VEVYE helps manage dry eye disease by improving – over the longer term – the signs and symptoms of this chronic disease.”
For more information about VEVYE, please visit vevye.com.