Amblyotech CEO Joseph Koziak describes the company as a “hybrid” life science and software company that is refining its tablet-based treatment platform for amblyopia in adolescents and adults.
Its Dig Rush is the first therapeutic video game that treats amblyopia, Koziak said at OIS@AAO 2015. It’s an alternative to patching, which can cost up to $3,300 over two years and has a 50% relapse rate. “The problem with patching is that it’s minimally effective in adolescents and not at all in adults,” he said.
He explained that Dig Rush is a “left eye-right eye game”—essentially a separate game for the dominant and amblyopic eye—that trains both eyes concurrently. It uses a technology Amblyotech calls “Binoculear”. It can establish stereopsis in six weeks, he said.
The game is embedded in a dedicated iPad that the physician calibrates for each patient. The patient takes the iPad home for six weeks of daily one-hour sessions. Dig Rush monitors compliance with the therapy in the background and reports back the physician. The platform also reports data to a HIPAA-compliant cloud. “Accordingly we would be collecting the largest dataset on amblyopia in the world,” Koziak said.
Clinical trials of the platform have compared individuals who had failed patching, and compared results of those who played the game with a patch vs. those who did not. “We found that the patch cohort had negligible improvement compared to the binocular approach,” Koziak said.
National Institutes of Health provided $5 million to support a 500-patient clinical trial, for which Amblyotech expects a final readout in March 2016, Koziak said. It has filed a premarket approval application (PMA) with the FDA and anticipates marketing clearance in 2016, he said.
Mr. Koziak has proven leadership skills and extensive experience in all aspects of the medical devices and biotech industries.