Grifols Receives FDA Clearance to Begin Phase 2 Trial of Immunoglobulin Eye Drops for Dry Eye Disease

Grifols has announced FDA clearance of its Investigational New Drug (IND) application, allowing the company to initiate a phase 2 clinical trial of GRF312 ophthalmic solution—an investigational immunoglobulin (IG) eye drop therapy for dry eye disease (DED). If successful, this could become the first approved ocular surface indication for immunoglobulin and represent a novel therapeutic approach for DED.

About GRF312 and the Phase 2 Trial

GRF312 is a topical immunoglobulin-based eye drop formulation developed by Grifols, a global leader in plasma-derived medicines. The upcoming phase 2 study will evaluate the safety, tolerability, and efficacy of GRF312 in 100 patients with dry eye disease and is expected to begin in the third quarter of 2025.

The new trial builds upon data from a previous pilot phase 1/2 study conducted by Grifols’ partner, Selagine, at the University of Illinois College of Medicine, Department of Ophthalmology. In that study, patients received twice-daily doses of immunoglobulin-based eye drops over eight weeks.

Key Findings from the Phase 1/2 Pilot:

       • Significant reduction in signs and symptoms of dry eye disease

       • No difference in tolerability or adverse events compared to placebo

A Novel Approach to Dry Eye Disease

According to Dr. Jörg Schüttrumpf, Chief Scientific Innovation Officer at Grifols:

“We believe our immunoglobulin eye drops have the potential to make a qualitative leap in how dry eye disease is treated. Research suggests that the broad-spectrum anti-inflammatory and immunomodulatory properties of an ocular surface IG are superior to currently approved therapies, including artificial tears and anti-inflammatories.”

The development of GRF312 leverages Grifols’ deep expertise in immunoglobulin science, with the goal of addressing an unmet need for millions of patients worldwide who continue to experience inadequate relief with existing treatments.

Strategic Collaboration with Selagine

In March 2023, Grifols and Selagine entered into a collaboration and licensing agreement, granting Grifols exclusive global rights to Selagine’s immunoglobulin-based dry eye therapy. This partnership enables Grifols to advance GRF312 as a potential first-in-class treatment for DED.