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SEC filingPRF Technologies announced FDA clearance of its IND application for OcuRing™-K, enabling the initiation of a Phase II clinical trial for post-cataract pain and inflammation.
PRF Technologies Ltd. achieved a significant regulatory milestone with the FDA clearance of its Investigational New Drug (IND) application for OcuRing™-K. This clearance enables the advancement of the company's drop-less ocular drug-delivery platform into Phase II clinical development in the United States. OcuRing™-K is a patent-protected, bio-erodible intraocular ring designed to deliver ketorolac through a single intraoperative application, addressing pain and inflammation following cataract surgery. The platform differentiates itself by offering sustained, localized drug release, potentially eliminating the burden of complex post-surgical eye-drop regimens and improving patient compliance. Executive Chairman Ehud Geller highlighted the clearance as a meaningful step in advancing the company's ophthalmic strategy. PRF plans to initiate a multi-center Phase II trial with patient enrollment expected in the second half of 2026, evaluating endpoints related to pain reduction, inflammation control, and safety. The development is being conducted through LayerBio, Inc., PRF's majority-owned subsidiary, which the company believes represents a differentiated ophthalmic platform with potential expansion into additional product candidates and indications.