iVizia lubricant eyedrops combine hydrating and protecting ingredients to provide symptom relief.

Unique ingredients from what its maker says is the No. 1 selling drop for treating dry eye in Europe have made their US debut. Thea, in partnership with Similasan, has introduced iVizia lubricant eyedrops and gel. iVizia is sold over the counter and is designed to be used as a first step in addressing dry eye symptoms.

HOW IT WORKS

Like Thea’s top-selling prescribed product in Europe, Thealoz Duo, iVizia contains trehalose and hyaluronic acid (HA). iVizia is also formulated with povidone (polyvinylpyrrolidone [PVP]), an active ingredient for over-the-counter eye products that the FDA deems safe and effective.

Trehalose acts as a bioprotectant and osmoprotectant agent by helping cells such as those on the corneal and conjunctival epithelium maintain their water content, protecting lipids and proteins in cell membranes. “These features help suppress cell apoptosis as well as inflammatory and proteolytic metalloproteinase expression, therefore protecting epithelial cells from drying out and reducing inflammatory mediators in tears,” says Clara C. Chan, MD, FRCSC, FACS, clinical assistant professor of ophthalmology at the University of Toronto, Canada, who has used Thealoz Duo and recommends the drops to patients.

“Hyaluronate coats the ocular surface extremely well with great staying power, which enhances hydration and lubrication, and reduces tear evaporation,” Dr. Chan says. The unique combination of trehalose and HA increased tear film thickness for up to 240 minutes in a 2015 study by Schmidl et al. “Without sodium hyaluronate as an ingredient, this wouldn’t be possible.”

Simply put, “Sodium hyaluronate and trehalose are the best hydrating agents that exist; having both of them in one product is a huge plus,” says Marguerite B. McDonald, MD, FACS, cornea/refractive/cataract surgeon at OCLI Vision in Oceanside, N.Y., and clinical professor of ophthalmology at NYU Langone Medical Center in New York, N.Y., and Tulane University Health Sciences Center in New Orleans, who has used Thealoz Duo.

Unlike some other preservative-free products for dry eye, Dr. McDonald says patients have reported that iVizia doesn’t leave residue on their lids and lashes, nor does it cause burning when instilled. “Patients are happy that their vision remains clear with iVizia and that they have long-lasting comfort,” she says.

Results from in vivo studies of iVizia and Thealoz Duo demonstrated the same rheological behaviors and pre-clinical effects between the two products, the company reports. “This means that iVizia formulated with povidone achieves the same results for patients as Thealoz Duo,” says Susan Benton, MBA, general manager and head of US Thea Pharma Inc. in Lexington, Mass.

PRESERVATIVE-FREE BENEFITS

Almost as important to what is in iVizia drops is what is not — they are completely preservative free. “Chronic use and exposure to preservatives on the ocular surface induces toxicity and adverse changes to the ocular surface,” Ms. Benton says.

In fact, Dr. McDonald says only mild dry eyes can tolerate preserved tears. “In moderate to severe dry eye patients, preservatives can actually worsen a dry eye condition,” she says.

Because of its unique combination of ingredients and by being preservative free, iVizia is suitable for all types and causes of dry eye (eg, aqueous deficient, evaporative, result of surgery or prolonged contact lens use), Ms. Benton explains.

“Wearing contact lenses is a leading cause of ocular surface dryness and discomfort, and research shows it is the number one reason for lens dropout over time,” Ms. Benton says, pointing to data from Pucker and Tichenor (pubmed.ncbi.nlm.nih.gov/32612404 ). “Having a drop that won’t interfere with contact lens wear is important.”

The drops are also ideal for patients either before or after surgery. “It is best to avoid the toxicity from preservatives around surgeries while the ocular surface is healing to optimize surgical outcomes,” Ms. Benton notes.

WHEN TO PRESCRIBE

The use of OTC drops is considered a first-line approach for anyone with the classic symptoms of dry eye articulated in multiple dry eye treatment algorithms, says Ms. Benton.

These symptoms include grittiness, foreign-body sensation, fluctuations in vision, blurred vision, itching/watering/burning of the eyes, red eyes and light sensitivity, Dr. Chan notes.

“iVizia was designed to serve all dry eye patients with one or more of these symptoms and to simplify the approach to dry eye relief for OTC tears for eye-care professionals,” Ms. Benton says.

AN INNOVATIVE BOTTLE DESIGN

Thea’s proprietary ABAK (“without benzalkonium chloride”) bottle is the result of decades of research and development to deliver the convenience of a multi-dose bottle while maintaining preservative-free sterility of the formulation in the bottle for up to 3 months after first use, Ms. Benton says.

“Typical preservative-free drops come in single-use vials, which can be hard to squeeze, especially for elderly patients with weaker pincer strength or arthritis,” adds Dr. Chan. “If the vials or other preservative-free multi-dose bottles are pressed too hard, then the patient’s eye is flooded with excess drops, which are messy.” Each time the iVizia bottle is squeezed, a reproducible 30 microliter drop is dispensed. A 10-mL bottle delivers 300 drops consistently.

Patients may also inadvertently touch the bottle’s tip to their eyelashes. The tip contains a filter cartridge and membrane that prevents contamination of the drops in the reservoir, like a Brita water filter, Dr. Chan explains.

Finally, multiple vials produce a lot of waste. In this age of increased awareness for how plastics can impact the environment, a multi-use bottle is more environmentally friendly, Dr. Chan concludes. OM