The U.S. Food and Drug Administration (FDA) on Tuesday cleared PRF Technologies Ltd.’s (NASDAQ:PRFX) Investigational New Drug application for OcuRing-K, enabling the company to move into a Phase 2 trial targeting pain and inflammation following cataract surgery.
The milestone advances PRF’s strategy to develop a sustained-release, drop-less therapy aimed at simplifying post-operative care.
The company is focused on the reformulation of established therapeutics and developing AI-driven energy optimization technologies through its DeepSolar platform.
FDA Clearance Advances Clinical Development
The IND clearance allows PRF, alongside its majority-owned subsidiary LayerBio, Inc., to initiate a multi-center Phase 2 study in the U.S. The trial is expected to begin enrolling patients in the second half of 2026 following startup activities.
The study will assess key endpoints, including pain reduction, inflammation control, and overall safety in patients undergoing cataract procedures.
Focus On Drop-Less Drug Delivery
OcuRing-K is a patent-protected, bio-erodible intraocular ring designed for single-use application during surgery. It delivers ketorolac directly to the surgical site over time, potentially removing the need for post-operative eye drops.
PRF is positioning the therapy as a solution to compliance challenges associated with traditional regimens, which often require weeks of steroidal and nonsteroidal eye drops.
Broader Platform Opportunity
Cataract surgery remains one of the most common procedures globally, yet recovery protocols still rely heavily on patient-administered drops.
PRF believes its intraoperative, sustained-release approach could offer a differentiated alternative by reducing dosing burden and improving adherence.
The company also pointed to broader potential within its LayerBio platform, which may support additional ophthalmic applications, including NSAIDs, steroids, antibiotics, and anti-VEGF therapies.
PRF said its ownership stake in LayerBio could serve as a long-term value driver as it expands its ophthalmology pipeline across multiple indications.
PRFX Price Action: PRF Technologies shares were down 7.05% at $2.11 during premarket trading on Tuesday. The stock is trading near its 52-week low of $1.79, according to Benzinga Pro data.
Image via Shutterstock/ Rulo Jmp
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