Refocus Group’s goal, according to CEO Mike Judy, is to become the preferred surgical alternative for the treatment of presbyopia. The VisAbility Implant System (VIS) is a “simplified procedure that delivers secure, uncomplicated, and consistent placement of the scleral implants,” he said.
“This platform offers the only presbyopic solution that provides a full range of focus without compromise,” said Judy. The system does not affect the crystalline lens and is “completely reversible” if necessary.
Implantation is a four-step process that begins by placing the VIS docking station, including creating the scleral tunnel, placing the implant using shuttle/tubing, and locking the VIS implant into place. “Experienced surgeons” can complete surgery in under 15 minutes, Judy said.
Refocus began a pivotal trial of the system in January 2015, and completed study enrollment in March 2016, with about 340 eyes enrolled at 13 centers. This 36-month study has preliminary results (n = 20), with 95% of eyes 20/40 or better and 70% at 20/32 or better distance corrected near visual acuity (NVA), hesaid, and all eyes at 20/40 and 90% at 20/25 or better with uncorrected NVA. For those with 36-month data, 95% said their vision was significantly better or better than baseline.
Refocus plans to submit to the FDA in third-quarter 2017, Judy said, and expects an approval in the first half of 2018.
“This system provides all gain and no loss,” he said. “When we get FDA approval, it will be a great option for patients.”
Mike Judy joined Refocus Group in 2013 as the CEO. Mike recently served as CCO for AcuFocus leading the sales and marketing team as they introduced the KAMRA corneal inlay.