Allotex Files IDE with FDA for Collagen-Based Corneal Implant

Allotex announced the submission of its investigational device exemption (IDE) to the FDA, marking a step toward US clinical trials of the company’s human collagen-based corneal implant, Allo-1.

Allo-1 offers a novel approach to near vision enhancement through biologic tissue addition. The implant is designed to augment the cornea using precision-shaped human collagen—offering a reversible, minimally invasive alternative to reading glasses and contact lenses.

“This IDE submission is more than a regulatory milestone—it’s a signal that biologic refractive surgery is moving into clinical reality,” Michael Mrochen, PhD, CEO of Allotex, said in a company news release. “We’ve built a platform that merges the precision of laser-shaped optics with the elegance of natural tissue. It’s designed to fit seamlessly into the daily workflows of refractive surgeons.”

The planned US clinical trial will evaluate the safety and efficacy of Allo-1 in patients with age-related near vision challenges, including presbyopia. The study is expected to launch at multiple investigational sites across the country.

“Combining the benefits of natural tissue with precision-shaped optics is one of the most sophisticated evolutions we’ve seen in this space,” said Vance Thompson, MD, internationally recognized refractive surgeon and Professor of Ophthalmology at the Sanford School of Medicine, University of South Dakota. “With this approach, you’re not just correcting vision—you’re preserving all future options for lifelong sight.”