At a local retail pharmacy, a quick count revealed approximately 50 dry eye products on the store shelves, only about five of which stated that they were preservative free. Now added to that list (and previously only available in its preserved form) is FRESHKOTE Preservative Free (PF).

Available over the counter, this eyedrop offers a unique formula suitable for mild to severe dry eye patients. It is also sold online (www.freshkotepf.com ) and by some physicians out of their practices. Eyevance Pharmaceuticals acquired the drug in September 2018.¹

WHAT MAKES IT UNIQUE?

According to Marguerite McDonald, MD, FACS, a clinical professor of ophthalmology at both NYU and Tulane and a cornea, refractive and anterior segment specialist with Ophthalmic Consultants of Long Island, N.Y., FRESHKOTE PF supports the integrity of all three layers of the tear film. This is achieved by three specific components. Povidone 2% integrates with and supplements the lipid layer of the tear film, thickening it to reduce evaporation, and lubricating and soothing the ocular surface.² “Additionally, a lacrophilic aqueous solution is added, which interacts properly with both the lipid and mucin layers, and a mucomimetic polymer blend that is designed to achieve complete wetting,” Dr. McDonald adds.

The phospholipid blend is a combination of a completely hydrolyzed and partially hydrolyzed polyvinyl alcohol, such that the hydrophobic acetate side chains adhere to the dry areas on the surface of the eye, while the hydrophilic groups attract water to maintain the mucoaqueous layer.³ “The patented polymer blend of polyvinyl alcohol 2.7% results in a high oncotic pressure, which assists in removing excess water from damaged epithelium, compacting the cells and enhancing adhesiveness,” adds Dr. McDonald. Oncotic pressure is a form of colloidal osmolarity that causes water to move from one location to another within body tissues.⁴

FOR MORE THAN JUST DED

Artificial tears and nutritional supplements are Dr. McDonald’s first defense against mild dry eyes with a tear osmolarity greater than 295 mOsm/L. For moderate dry eyes with a tear osmolarity of 317 mOsm/L or greater, she adds lifitegrast or cyclosporine, often with a tapering dose of loteprednol etabonate gel for a one-month induction period; she also switches patients to non-preserved artificial tears administered every two hours while awake. FRESHKOTE PF can be used for mild dry eyes but is also well suited to moderate and severe dry eye cases.⁵

“Because of its osmolarity, allowing it to pull water out of an edematous cornea and facilitate epithelial adhesion, FRESHKOTE PF is very useful for Fuch’s dystrophy, bullous keratopathy and recurrent erosion patients,” Dr. McDonald explains. “It is also suited for any level of dry eye disease (both aqueous and evaporative) and meibomian gland dysfunction and any postoperative patient (cataract, LASIK, PRK, PTK, pterygium, etc.) due to its preservative-free formulation.”

PRESERVATIVE FREE, PLUS

The eyedrop is available in a 10 ml multidose bottle. The multiuse, microbiologically sterile, Novelia bottle consists of one-way valves and a venting system that blocks contaminated air and liquid from entering. Its sterility has been tested and confirmed for a treatment duration of up to 90 days.⁵

“There is an industry-wide trend to move from unit dose vials to multidose preservative free (MDPF) bottles. The Novelia MDPF system is similar to that being used by Oasis Medical MDPF Tears; the Restasis Multidose PF bottle utilizes the Aptar Squeeze format, and Retaine HPMC artificial tears are produced in an MDPF bottle with an airless pump design,” Dr. McDonald says.

The goal is the same: removing the preservatives alleviates the irritation often caused by repeated dosing with preserved products, which aids in comfort and increases compliance. The FRESHKOTE PF bottle’s blue tip allows the patient a target when administering each dose, and the bottle is easy to squeeze with only one metered drop being released at a time. The multidose modality uses less plastic, is more affordable than unit doses and is easy to carry, the company says.⁶

YOU CAN SUPPLY IT

Because FRESHKOTE PF is kept behind the pharmacy counter, patients can ask their pharmacist for it or buy it from their eye-care professional. The direct-to-consumer price is $33.56 per bottle; however, Eyevance Pharmaceuticals offers volume pricing to ophthalmologists, with discounts based on quantity. FRESHKOTE PF multidose bottles are sold in increments of 12; for orders of 288 bottles or more, the cost decreases to $19.86 per unit.

CONCLUSION

Dr. McDonald previously prescribed and continues to recommend the new FRESHKOTE PF in her practice. “Its ability to support all three layers of the tear film and remove excess fluid from the cornea are distinctive properties.”

Along with its preservative-free benefits in a multidose bottle, FRESHKOTE PF makes for an excellent addition to the dry eye armamentarium. OM

REFERENCES

1. Eyevance Pharmaceuticals Acquires FRESHKOTE Lubricant Eye Drop Family of Products from Focus Laboratories. https://www.prnewswire.com/news-releases/eyevance-pharmaceuticals-acquires-freshkote-lubricant-eye-drop-family-of-products-from-focus-laboratories-300710546.html . Accessed Jan. 30, 2019.
2. Larsen T. Artificial tears: A primer. EyeRounds.org. University of Iowa Carver College of Medicine. Nov. 16, 2016. http://webeye.ophth.uiowa.edu/eyeforum/tutorials/artificial-tears.htm . Accessed Feb. 1, 2019.
3. Holly FJ. Lacrophilic ophthalmic demulcents. US Ophthalmic Review. 2007:3:38-41.
4. Holly FJ, Esquivel ED. Colloid osmotic pressure of artificial tears. J Ocul Pharmacol. 1985 Winter;1:327-336.
5. McDonald M. Dry eye algorithms for the trenches. Ophthalmology Management. March 1, 2016. https://www.ophthalmologymanagement.com/issues/2016/march-2016/dry-eye-algorithms-from-the-trenches . Accessed Feb. 3, 2019.
6. Nemera announces that Novelia, its new preservative-free multidose eyedropper, is now used to dispense ophthalmic drops across 4 continents. https://www.nemera.net/wp-content/uploads/2015/04/Nemera-Press-release-NOVELIA_April-2015.pdf . Accessed Jan. 30, 2019.