FDA Confirms a 510(k) De Novo Path for EyeGate’s Device

EyeGate has announced that it plans to pursue a marketing clearance of its EyeGate Ocular Bandage Gel (EyeGate OBG), via the De Novo 510(k) pathway.

The ocular bandage gel is a synthetic biocompatible gel that coats the eye surface and designed to resist degradation under conditions present in the eye.

“We look forward to announcing the top-line data from our PRK pilot study by the end of the year,” the company said. — Cynthia Jessup