FDA Green Lights NovaBay’s intelli-Case


Product: intelli-Case
Top Line: NovaBay Pharmaceuticals has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its intelli-Case with hydrogen peroxide solutions.
Close Up: Hydrogen peroxide is the gold standard for disinfection of contact lenses, but can irritate the eye or fail to kill bacteria if not used correctly. The new intelli-Case ensures the adequacy of the disinfection cycle and that the contact lenses are safe for insertion into the eyes, potentially benefiting millions of contact lens users, according to NovaBay.
The intelli-Case from NovaBay Pharmaceuticals monitors the neutralization of hydrogen peroxide during the disinfection cycle with 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. Contact 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.
“Poor contact lens hygiene is a major risk factor for a range of eye complications,” explained 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 eyecare 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,” said Dr. Stroman. “The intelli-Case removes the guesswork.”