Harrow, a leading U.S. eyecare pharmaceutical company, has announced that VEVYE® (cyclosporine ophthalmic solution) 0.1%, a patented, non‑preserved, twice-daily (BID) dosed prescription drug based on a “water‑free” semifluorinated alkane eyedrop technology, is now available in the U.S. – and includes a 100% Money‑Back Guarantee program. VEVYE, uniquely dispensed in a 10 microliter drop, is the first and only cyclosporine‑based product indicated for treating both the signs and symptoms of dry eye disease (DED).
In commenting on the announcement, Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said, “We are thrilled to announce the availability of VEVYE for our customers and their patients. VEVYE is powered by the unique combination of the reliable and trusted active ingredient, cyclosporine, and a water-free semifluorinated alkane delivery vehicle, perfluorobutylpentane. We are excited to see VEVYE’s exceptional clinical trial data come to life as U.S. dry eye disease patients are now able to access and experience a highly tolerable product that provides rapid onset of relief and sustained improvement of both signs and symptoms of dry eye disease. Because of VEVYE’s unique combination of both a potent 0.1% cyclosporine solute and a pH- and osmolarity-free semifluorinated alkane, VEVYE is both evolutionary and revolutionary, solving an unmet need for eyecare professionals treating the tens of millions of American chronic dry eye disease sufferers.”
Dry eye disease (DED) is a common condition that occurs when the eyes do not produce enough tears or when the tears evaporate too quickly, and it is often associated with chronic inflammation. Untreated DED can lead to discomfort such as stinging, burning or blurry vision, and chronic DED can interfere with daily activities like reading and using a computer. More serious consequences include increased risk of eye infections and damage to the surface of the eye, which can potentially result in serious vision problems and even loss of sight. Causes of dry eye are varied and can include aging, certain medications, medical conditions, or environmental factors such as increased screen time and exposure to pollutants, all of which are contributing to a forecast of continued significant increase in DED. According to a 2020 report from Market Scope, DED affects more than 38 million Americans. In addition, 92% of this patient population remains un- or under-treated due to limited efficacy and poor tolerability of existing prescription and non-prescription choices.4
Comments from Ophthalmic KOLs (Key Opinion Leaders) on VEVYE
“As an ophthalmologist and ocular surface specialist, I have served as principal investigator in over 120 clinical trials, half of which targeted dry eye disease. As participants in VEVYE’s clinical trials, our team found the results to be compelling. The data in both consecutive registration trials demonstrated impressive efficacy, safety and tolerability, with rapid clinical onset beginning as early as 15 days and continuous improvement for more than one year. VEVYE represents not just an innovative treatment; it exemplifies the penultimate synthesis of outstanding vehicle with cyclosporine, the active pharmaceutical ingredient, boasting a superlative decades long track record. Tolerability and risk profile are impressive compared with most existing dry eye products, portending improved patient compliance. Indicated for both signs and symptoms, VEVYE should expand the market and fundamentally enhance dry eye disease treatment algorithms.”
— John D. Sheppard, M.D., M.M.Sc., F.A.C.S., corneal external disease fellowship trained ophthalmologist and founding senior partner of Virginia Eye Consultants, Norfolk, VA
“When a patient presents with dry eye disease, it is often difficult to initially classify them into a specific category, such as aqueous deficient, evaporative, or a combination of the two. In addition, they often present with inflammation leading to many of their dry eye symptoms. That is why VEVYE, with cyclosporine in a semifluorinated alkane solution, provides us with a valuable tool to address the signs and symptoms of dry eye holistically, regardless of etiology.”
— Paul Karpecki, OD, FAAO, Director, cornea and external disease, Kentucky Eye Institute, and associate professor, Kentucky College of Optometry UPIKE, Lexington, KY
“VEVYE continues the trend of advanced cyclosporine formulations coming to market that are designed to address key issues of onset of action and tolerability. As the first cyclosporine with an FDA indication for signs and symptoms and the first anti‑inflammatory drop in the new category of anhydrous or water-free formulations, VEVYE is well-positioned to add unique clinical value to the expanding market of excellent anti-inflammatory dry eye disease therapeutics.”
Read the full news release from Harrow.