Allotex Inc., a commercial-stage ophthalmic company with active European market adoption, today announced that the U.S. Food and Drug Administration (FDA) has conditionally approved its Investigational Device Exemption (IDE), authorizing the initiation of a U.S. clinical study for ALLO-1™, its proprietary tissue-based solution for presbyopia.

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.

“This is not an early science milestone — this is an expansion milestone,” said Michael Mrochen, Founder and CEO. “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.”

About Allotex

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 FDA’s conditional approval of an Investigational Device Exemption (IDE) permits the initiation of a clinical investigation but does not imply future regulatory approval in the United States. The Allo-1™ product is currently not approved for commercial use in the U.S.

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