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

Grifols, a producer of plasma-derived medicines, announced that the FDA has cleared the company’s investigational new drug (IND) application to initiate a phase 2 trial evaluating its immunoglobulin (IG) drops–GRF312 ophthalmic solution–for what could become the first ocular surface indication for an IG and a potential new treatment for dry eye disease (DED).

The study, which will analyze safety, tolerability and efficacy in 100 patients with DED, is expected to begin in the third quarter of 2025. It will build on a pilot phase 1/2 trial conducted at the University of Illinois College of Medicine, Department of Ophthalmology, by Grifols’ partner Selagine. Results showed that when treated with eye drops based on a Grifols IG product twice daily for 8 weeks, patients achieved a significant reduction in DED signs and symptoms, with no difference in tolerability or adverse events compared to placebo.  

“We believe our immunoglobulin eye drops have the potential to make a qualitative leap in how dry eye disease is treated,” Dr. Jörg Schüttrumpf, Grifols Chief Scientific Innovation Officer, said in a company news release. “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. We are using our extensive and deep knowledge of immunoglobulins to benefit the millions of patients globally who aren’t receiving sufficient relief.”

In March 2023, Grifols and Selagine announced a collaboration and licensing agreement under which Grifols would have worldwide exclusive rights to Selagine’s treatment.