US FDA clears Grifols' Investigational New Drug application for immunoglobulin drops for the treatment of DED

The phase 2 will evaluate the safety, tolerability, and efficacy in 100 patients with DED and is expected to begin in Q3 2025. Image credit: AdobeStock/frankenphoto

Global health care company Grifols has announced that the US Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application to initiate a phase 2 trial to assess its immunoglobulin (IG) drops (GRF312 ophthalmic solution) for the treatment of dry eye disease (DED).¹ The drop has the potential to become the first-ever ocular surface indication for an IG, according to a news release.

“We believe our immunoglobulin eye drops have the potential to make a qualitative leap in how dry eye disease is treated,” said Jörg Schüttrumpf, MD, MBA, Grifols’ chief scientific innovation officer, in the 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.”

The phase 2 study will evaluate the safety, tolerability, and efficacy in 100 patients with DED and is expected to begin in Q3 2025. The study will follow a pilot phase 1/2 trial that was conducted at the University of Illinois College of Medicine, Department of Ophthalmology by Selagine, a partner of Grifols that develops novel therapeutics for ocular diseases. Results from the pilot trial show when patients were treated with eye drops based on a Grifols IG product twice daily for 8 weeks, a significant reduction in DED signs and symptoms was observed. Additionally, no difference in tolerability or adverse events were observed when compared with placebo.¹

“Selagine and Grifols joining efforts and complementary expertise successfully led the treatment to a phase 2 clinical trial,” said Sandeep Jain, MD, founder and president of Selagine and BA field professor of ophthalmology at the University of Illinois Chicago, in the release. “The results obtained to date and this promising development reinforce the potential of this novel treatment approach to significantly improve the quality of life of dry eye disease patients.”

Selagine and Grifols have been in partnership since March 2023, when the companies announced a collaboration and licensing agreement in which Grifols would obtain worldwide exclusive rights to Selagine’s treatment. This works to combine Grifols’ manufacturing of IG therapies and Selagine’s research, medical expertise, and clinical experience in treating debilitating eye diseases.¹

Reference

1. Grifols receives FDA clearance of IND application for phase 2 trial of immunoglobulin drops for dry eye disease. News release. Grifols. May 21, 2025. Accessed May 21, 2025. https://www.grifols.com/en/view-news/-/news/grifols-receives-fda-clearance-of-ind-application-for-phase-2-trial-of-immunoglobulin-drops-for-dry-eye-disease