BOSTON, Mass. — Allotex Inc. said the U.S. Food and Drug Administration has conditionally approved its Investigational Device Exemption, clearing the way for the company to initiate a U.S. clinical study of ALLO-1™, its proprietary tissue-based solution for presbyopia.
The conditional IDE approval marks a transition for Allotex from commercialization in Europe, Canada, and other international markets to FDA-regulated clinical development in the United States, positioning the company for broader global expansion.
“This is not an early science milestone — this is an expansion milestone,” said Michael Mrochen, founder and chief executive officer of Allotex. “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.”
Allotex said commercialization of ALLO-1 is already underway outside the U.S., and the initiation of a U.S. clinical study represents a key step toward potential regulatory approval in the American market. The company said the IDE approval creates multiple near-term value inflection points as it advances its strategy to scale globally.
“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,” Mrochen said.
