FDA Clears NovaBay Pharmaceuticals' New Device for Disinfecting Contact Lenses with Hydrogen Peroxide

The high-tech cap of the intelli-Case has three LED lights labeled UNSAFE, BUSY and READY.

NovaBay® Pharmaceuticals, Inc., a biopharmaceutical company commercializing and developing novel approaches for the global eye-care market, including revolutionary non-antibiotic antimicrobial products, announces receipt of 510(k) clearance from the Food and Drug Administration (FDA) to market its novel intelli-Case with hydrogen peroxide solutions.

More than 24 million Americans now disinfect their contact lenses with a disinfection system to prevent potentially serious infections. But only about 2 million use the gold standard disinfection solution, hydrogen peroxide. That’s because hydrogen peroxide can be tricky to use. Too low a concentration and it doesn’t fully disinfect lenses; too high, and it can irritate the eye. Getting the concentration right is challenging because hydrogen peroxide degrades over time. Many ophthalmologists and optometrists favor the disinfection and lens material compatibility peroxide systems provide, yet side effects associated with misuse and non-compliance minimize peroxide system use.

“The intelli-Case is a highly innovative, extremely easy-to-use device for the millions of Americans who wear contact lenses and want to use the best disinfection system,” says Ron Najafi, PhD, NovaBay’s president and CEO. “We believe that intelli-Case can revolutionize contact lens care by making the peroxide disinfection system as simple as using multipurpose solutions. Following the launch of Avenova, intelli-Case is the second in a series of cutting-edge products being developed by NovaBay that target unmet needs in the eye care market and demonstrates our strong commitment to innovation.”

The intelli-Case monitors the neutralization of hydrogen peroxide during the disinfection cycle with sophisticated microprocessor electronics embedded in the cap of what otherwise looks like a standard peroxide lens case. The high-tech cap has three LED lights labeled UNSAFE, BUSY and READY. Lenses are placed into the case with hydrogen peroxide solution. The green light (READY) blinks when lenses are safe to insert into the eyes and continues to blink green until contact lenses are removed from the case.

“The intelli-Case can be co-packaged with a hydrogen peroxide disinfection/cleaning solution and we are actively seeking a partnership with a hydrogen peroxide manufacturer,” says Najafi. “Replacing the standard case that is typically boxed with hydrogen peroxide solutions with the intelli-Case will make for a highly differentiated product offering that we believe will be warmly welcomed by both eye care professionals and contact lens wearers.”

“Poor contact lens hygiene is a major risk factor for a range of eye complications,” explains David Stroman, PhD, NovaBay’s senior vice president for ophthalmology. “Americans make more than a million visits each year to emergency rooms, clinics or their eye-care professionals with contact lens-related issues. Patients often report irritation and/or red eye after insertion of their contact lenses, when the hydrogen peroxide solution has not been adequately neutralized. Failure to properly disinfect is a well-documented cause of contact lens-related infections. The intelli-Case is designed to ensure the adequacy of the peroxide disinfection cycle and that the contact lenses are safe for insertion into the eyes.

“The intelli-Case provides real-time information to the user through solution monitoring and blinking LED lights, indicating that their lenses can be safely placed into their eyes,” says Stroman. “The intelli-Case removes the guesswork.”

“The advantages of peroxide are well known, but compliance has remained a problem for many patients,” says Art Epstein, OD, FAAO, FABCO, FBCLA, DPNAP, a recognized authority on contact lens complications. “What I most like about intelli-Case is that it leverages high-tech, real-time analytics to foster improved patient compliance. From what I’ve seen, it can make a tremendous difference even for the compliance-challenged patients. I am really excited about this technology.”

Steven J. Lichtenstein, MD, FAAP, FACS, FAAO, a leading pediatric ophthalmologist, says, “The responses I’m getting from patients who have tested the intelli-Case are very positive. For instance, one individual reported that intelli-Case was easy to use and loved the fact that each morning she could safely put her lenses in her eyes without worrying about them burning. Like many other contact wearers, she has experienced severe pain from residual hydrogen peroxide that can occur with other peroxide disinfecting solutions. I plan to move my contact lens patients from multipurpose solutions (MPS) to intelli-Case as soon as possible.”

Source: NovaBay Pharmaceuticals, Inc.