FDA Grants IND Clearance for Immunoglobulin Eye Drops to Treat Dry Eye Disease Patients in a Phase II Clinical Study

CHICAGO, May 21, 2025 /PRNewswire/ -- Selagine, Inc., a spin-out company from the University of Illinois Chicago (UIC), announced today that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for immunoglobulin (IG) drops (GRF312 Ophthalmic Solution) for the treatment of patients with dry eye disease (DED). An IG eye drop is an anti-inflammatory and immunomodulatory biologic drug that is generated from pooled human plasma from thousands of healthy donors. In a first-in-human pilot clinical trial conducted at the University of Illinois College of Medicine (UI COM), Department of Ophthalmology & Visual Sciences, immunoglobulin eye drops caused a significant reduction in signs and symptoms of dry eyes with no difference in tolerability or adverse events.

In March 2023, Selagine announced a research, development, and sublicense agreement with Grifols, the sponsor of the IND and a global leader in plasma-derived medicines, for the development and commercialization of immunoglobulin eye drops for DED. Initial developmental work for the IG eye drops was performed in the Department of Ophthalmology & Visual Sciences at the UIC College of Medicine and Loyola University, supported by UI Health Pharmacy, and is the outcome of over a decade of research and development efforts, with grant funding from the National Eye Institute (NEI)/National Institutes of Health (NEI R24EY032440), Research to Prevent Blindness and UIC's Office of Technology Management. The Selagine-Grifols sublicense agreement has since been expanded to include the treatment of chemical traumatic injuries with IG eye drops.

Inflammatory proteins (cytokines or chemokines), cells (neutrophils, T-cells, and dendritic cells), complement system components, and pathogenic antibodies are present on the ocular surface in chronic dry eye disease; therefore, several different mechanisms of inflammation are simultaneously active and contribute to symptoms and signs of dry eye disease. IG eye drops have beneficial actions on each of these mechanisms, thus providing broad-spectrum anti-inflammatory actions and potentially providing mechanistic superiority over currently approved therapies for chronic dry eye disease. The anti-inflammatory actions of eye drops that are currently approved for treating chronic dry eye disease are narrow-spectrum and limited primarily to targeting T-cell inflammatory mechanisms.

"The IND clearance opens the door to clinical trials for establishing the safety and efficacy of IG eye drops and brings us one step closer to meaningfully improving outcomes for people suffering from dry eyes" says Sandeep Jain, MD, Professor of Ophthalmology & Visual Sciences at UIC and Founder and President of Selagine, Inc. "With its strategic commitment to ophthalmics and its global leadership in immunoglobulins, we believe Grifols provides an ideal partner for realizing Selagine's goal of developing the full potential of plasma protein-based eye drops across all ophthalmic indications."

"Selagine's success at moving the IG product forward with strong industrial and government partnerships is a testament to UIC's commitment to conducting translational research with multiple applications to benefit patients and providers." Says Suseelan Pookote, PhD, Senior Director of UIC's Office of Technology Management. "With this IND clearance, Selagine's IG product adds to UIC's strong clinical pipeline with eight products in Phase II clinical trials advancing towards the market."

"We believe our immunoglobulin eye drops have the potential to make a qualitative leap in how dry eye disease is treated," said Dr. Jörg Schüttrumpf, Grifols Chief Scientific Innovation Officer. "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".

About Dry Eye Disease

Dry eye happens when the eyes do not make enough tears to stay wet, or when the tears do not work correctly. This can make the eyes feel uncomfortable, and in some cases it can also cause vision problems. Dry eye affects millions of Americans every year, especially older Americans and women. Autoimmune conditions, such as Sjogren's syndrome, rheumatoid arthritis, Stevens-Johnson syndrome and ocular graft-versus-host-disease are associated with a more severe form of dry eyes. As many as one-third of patients visiting ophthalmology clinics report dry eye symptoms, making it one of the most common conditions seen by ophthalmology specialists. Dry eye disease is the 3rd largest indication of the overall ophthalmology market. The global dry eye market size is projected to reach more than USD 6.5 billion by 2027.

For more information about dry eye see: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/dry-eye

About Selagine

Selagine Inc. is a clinical-stage spin-out company from the University of Illinois Chicago (UIC) that is commercializing technology which was developed within the University of Illinois College of Medicine (UI COM), Department of Ophthalmology & Visual Sciences. UI COM places a strong emphasis on supporting faculty efforts toward academic entrepreneurship through initiatives such as the COMassist entrepreneur-in-residence program led by Dr. Michael Flavin. Selagine is focused on developing novel therapeutics to help patients suffering from a variety of debilitating ocular diseases, and to improve the quality of life in conditions where effective therapies do not exist.

Selagine's office is located within the Illinois Medical District and its R&D laboratory is housed in UIC's Incubator Laboratory Facility, a hub for entrepreneurship and innovation at the University.

For more information, visit www.selagine.com

About Grifols

Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. A leader in essential plasma-derived medicines and transfusion medicine, the company develops, produces and provides innovative healthcare services and solutions in more than 110 countries.

Patient needs and Grifols' ever-growing knowledge of many chronic, rare and prevalent conditions, at times life-threatening, drive the company's innovation in both plasma medicines and other biopharmaceuticals to enhance quality of life. Grifols is focused on treating conditions across four main therapeutic areas: immunology, infectious diseases, pulmonology and critical care.

For more information about Grifols, please visit www.grifols.com

SOURCE Selagine, Inc.