Allotex Advances from European Commercialization to U.S. Clinical Phase

Allotex Inc. has received Investigational Device Exemption (IDE) conditional approval from the U.S. Food and Drug Administration (FDA) to begin a U.S. clinical study for ALLO-1, its proprietary tissue-based presbyopia solution.

This conditional IDE approval represents a significant step-change in value, transitioning Allotex from commercialization in Europe, Canada, and other regions to FDA-governed U.S. clinical execution, and positioning the company for global scale, company executives claim.

“This is not an early science milestone—this is an expansion milestone,” Allotex Founder/CEO Michael Mrochen stated. “Allotex already has real-world clinical use in Europe, and with the FDA now allowing the clinical study to begin, we can translate that momentum into U.S. clinical data, materially accelerating our path toward creating a new category in surgical presbyopia correction. With commercialization outside the U.S. already underway, FDA approval to begin a U.S. clinical study, and multiple near-term value inflection points ahead, Allotex is selectively engaging investors to support its global scale-up strategy.”

The Allotex TransForm lenticule  is a piece of acellular cornea, sterilized with electron beam radiation and shaped to a particular shape using a laser. The availability of precise laser shaping systems and sterile corneas are the key factors that make the use of allogenic implants possible.

The TransForm lenticule is applied under a femtosecond created corneal flap on a stromal bed. The goal is to enhance the visual performance of the patient with a material that is 100% biocompatible and precisely shaped for the individual’s needs.

The lenticules are designed to be placed directly on top the recipient’s stroma, which has been exposed by the creation of a thin, femtosecond laser created flap. After placement, the flap is the laid down over the TransForm lenticule and smoothed in the normal fashion. The final shape, after laser sculpting, is 2 mm -3.5 mm in diameter, with a central thickness of 15-25 microns. The diameter is such that the patient is expected to have improved near and intermediate vision and will also retain distance vision from the rays entering the pupil around the periphery of the TransForm lenticule .

Allotex is a commercial-stage ophthalmic company in Europe and a U.S. clinical-stage company pioneering Tissue Addition Technology—a new category of vision correction designed to restore vision using natural human tissue. The Allo-1 product is currently not approved for U.S. commercial use.