Harrow’s dry eye treatment hits the market

(Image Credit: AdobeStock/あんみつ姫)

Harrow announced that cyclosporine ophthalmic solution 0.1% (Vevye) a patented, non‑preserved, twice-daily (BID) dosed prescription drug based on a “water‑free” semifluorinated alkane eyedrop technology, is now available in the United States.

According to a news release from the company,¹ the solution also is backed by a 100% money-back guarantee program.

Cyclosporine ophthalmic solution 0.1% is dispensed in a 10 microliter drop, and is the first and only cyclosporine‑based product indicated for treating both the signs and symptoms of dry eye disease (DED).

In the news release, Harrow Chairman and CEO Mark L Baum noted the company is pleased to announce the availability of cyclosporine ophthalmic solution 0.1% for its 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,” he said in the news release. “We are excited to see Vevye’s exceptional clinical trial data come to life as US 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,” Baum added.

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.¹

John D Sheppard, MD, MMSc, FACS, a corneal external disease fellowship-trained ophthalmologist and founding senior partner of Virginia Eye Consultants, Norfolk, Virginia, has 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,” he said in the news release. “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.”

Moreover, Sheppard noted the solution 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” he concluded in the news release.

William B Trattler, MD, a cataract, refractive, and corneal surgeon and Director of Cornea at the Center for Excellence in Eye Care, Miami, Florida, pointed out that as an eyecare professional, he recognizes the critical need for a dry eye product that not only acts swiftly and effectively, but also is comfortable enough to encourage continued patient use.

“A dry eye product that is well tolerated, has no or mild discomfort or adverse effects, and can easily be incorporated into a patient’s daily routine is key to successful long-term management of dry eye syndrome,” he said in the news release. “Vevye’s twice‑daily dosing should also contribute to patient compliance, thus promoting overall effectiveness of the treatment. I am excited to see the positive changes that VEVYE can bring to patients suffering from dry eye disease.”

Richard Adler, MD, a corneal, refractive, and external disease fellowship-trained ophthalmologist at Belcara Health, Baltimore, Maryland, pointed out that cyclosporine ophthalmic solution 0.1% 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,” Adler said in the news release.

Paul Karpecki, OD, FAAO, director, cornea and external disease, Kentucky Eye Institute, and associate professor, Kentucky College of Optometry UPIKE, Lexington, Kentucky, noted that 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,” he said in the news release.

Courtney Bovee, MD, cataract and glaucoma surgeon at The Macula Center and Blue Ocean Clinical Research Center, Tampa Bay, Florida, has been anticipating the release of cyclosporine ophthalmic solution 0.1%.

“As a glaucoma specialist who treats advanced glaucoma, I’ve been looking forward to the availability of Vevye, a 2-hit treatment for ocular surface disease targeting longstanding inflammation and corneal damage in as quickly as 15 days,” Bovee said in the release. “A large portion of patients with glaucoma also have dry eye disease with extensive cornea damage due to the use of topical glaucoma medications. I look forward to the rapid relief my patients will receive from the addition of preservative-free VEVYE.”

John A Hovanesian, MD, a cataract, corneal and laser eye surgeon and a principal at Harvard Eye Associates, Laguna Hills, California, pointed out that the solution has been a long time coming.

“Clinicians have been waiting a long time for a dry eye treatment that combines the effectiveness of cyclosporine with the tolerability of this unique semifluorinated alkane vehicle,” he said in the news release. “In Vevye, the vehicle makes all the difference, allowing the product to spread evenly over the ocular surface with longer residual time and increased penetration of cyclosporine.”

How to order Vevye

According to the company, eyecare professionals can send prescriptions for cyclosporine ophthalmic solution 0.1% using their electronic medical record (EMR), directly to Harrow’s dedicated pharmacy partner, PhilRx. Prescriptions can also be sent to any retail pharmacy. Vevye is fully stocked in the wholesale distribution channel and can be shipped to any retail pharmacy, generally within 24 hours of order placement.

Moreover, Harrow noted in its news release, Vevye is also available directly through wholesale distributors, including McKesson, Cardinal and Cencora (f/k/a AmerisourceBergen).

Harrow also has established a VEVYE Patient Access program, under which eligible patients may receive their first VEVYE prescription for as low as $0.

References:

1. Harrow Announces Availability of VEVYE (Cyclosporine Ophthalmic Solution) 0.1%, the First and Only Cyclosporine-Based Product Indicated for Treating Both Signs and Symptoms of Dry Eye Disease. www.businesswire.com. Published January 11, 2024. Accessed January 11, 2024. https://www.businesswire.com/news/home/20240111803510/en/Harrow-Announces-Availability-of-VEVYE