Injectsense’s continuous IOP monitoring system for chronic glaucoma patients has received the Breakthrough Device Program (BDP) designation from the U.S. Food and Drug Administration (FDA). The company’s IOP Connect™ system is based on a miniscule, long-term implantable sensor that is delivered to the eye by injection during a five-minute in-office procedure.
The BDP designation is intended to help patients and physicians receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Injectsense with priority review and interactive communication regarding device development and clinical trial protocols, all the way through to commercialization decisions. IOP-Connect is still in research and development and is not available for sale anywhere in the world.
Today, ophthalmologists have no way of knowing how individual IOP varies over a 24-hour period. Measurements using tonometry are only static snapshots taken in the doctor’s office a few times a year during office hours lacking months of crucial IOP information in between doctor visits. However, IOP is known to fluctuate significantly throughout the day, especially at night, and with certain kinds of physical activity.
IOP-Connect will offer chronic continuous IOP monitoring within a digital health framework, enabling doctors for the first time to derive clinically actionable IOP data for 4 million US patients between office visits. Unlike other proposed sensors, the Injectsense device minimizes patient intervention through its autonomous data collection.
“The ophthalmology community needs a device that can be placed in the eye to monitor IOP, day and night, continuously for the lifetime of a patient. This will allow clinicians to better measure compliance and the effectiveness of every glaucoma therapy, enhancing outcomes.” said Dr. Richard Lindstrom, founder and attending surgeon at Minnesota Eye Consultants. “The designation of IOP Connect as a breakthrough device by the FDA is also a significant step forward and will help speed market access to the Injectsense system, as will the recent CMS proposal to provide national Medicare coverage for breakthrough devices for four years starting on the day of FDA market authorization.”
“The Injectsense team has its feet in both semiconductor and medical systems expertise and has worked hard to develop a miniature sensor that blends high performance with expected safety and efficacy,” said Ariel Cao, president and CEO of Injectsense Inc. “With the BDP designation in hand, we look forward to moving on to in-depth animal and human studies.”
Full press release: https://www.injectsense.com/news