PRF Technologies receives FDA clearance for OcuRing-K phase 2 trial
PRF Technologies Ltd. (NASDAQ: PRFX) announced that the U.S. Food and Drug Administration has cleared the company's Investigational New Drug application for OcuRing-K, allowing the initiation of a Phase II clinical trial in patients undergoing cataract surgery.
OcuRing-K is a bio-erodible intraocular ring designed to deliver ketorolac through a single intraoperative application. The device is intended to provide sustained, localized drug release at the surgical site, potentially eliminating the need for post-surgical eye-drop regimens.
"FDA clearance of the IND for OcuRing-K is a meaningful milestone for PRF and an important step in advancing our ophthalmic drug-delivery strategy," said Ehud Geller, Executive Chairman of PRF Technologies. "We believe OcuRing-K has the potential to address a clear unmet need in cataract surgery by offering a drop-less, inside-the-eye, sustained-release approach designed to improve treatment consistency and simplify post-operative care."
The company plans to initiate a multi-center Phase II clinical trial in the United States following completion of trial-startup activities. Patient enrollment is expected to begin in the second half of 2026. The study will evaluate endpoints related to pain reduction, inflammation control, and safety.
PRF Technologies operates through its majority-owned subsidiary LayerBio, Inc. The company focuses on reformulating established therapeutics for post-operative pain management and develops AI-driven energy optimization technologies through its DeepSolar platform.
