OR WAIT null SECS
FDA Grants IND Clearance to Immunoglobulin Eye Drops for Dry Eye Disease
Early data on Selagine, Inc.’s immunoglobulin eye drops have indicated significant reductions in DED symptoms without differences in adverse events or tolerability.
The US Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for immunoglobulin (IG) drops, an anti-inflammatory and immunomodulatory biologic drug intended for the treatment of dry eye disease (DED).1
Announced on May 21, 2025 by Selagine, Inc., a company spun out from the University of Illinois Chicago (UIC), this designation comes on the heels of a recent first-in-human pilot trial that indicated the IG drops, currently named SLG-100, cause a significant reduction in signs and symptoms of DED with no difference in tolerability and limited adverse events.1
“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,” said Sandeep Jain, MD, professor of ophthalmology and visual sciences at UIC and founder and president of Selagine Inc.1
DED affects >100 million people globally. Inflammatory proteins, such as cytokines or chemokines, cells such as neutrophils, T-cells, and dendritic cells, complement system components, and pathogenic antibodies are all present on the ocular surface in chronic DED. This means several mechanisms of inflammation are active simultaneously, all of which contribute to signs and symptoms of DED.2
IG eye drops are anti-inflammatory and immunomodulatory biologic drugs, generated from pooled human plasma from thousands of healthy donors. They have a beneficial effect on each of the inflammatory mechanisms, providing broad-spectrum anti-inflammatory actions. Additionally, investigators believe the drops may provide mechanistic superiority over existing therapies for chronic DED; most currently available treatments are narrow-spectrum, limited primarily to targeting T-cell inflammation. 1
Selagine’s Phase 1/2 clinical trial saw participants treated with eye drops based on Grifols Flebogamma DIF twice daily for 8 weeks. When compared with vehicle, results indicated a significant reduction in DED symptoms with no significant difference in tolerability or adverse events.3
In 2023, Selagine entered into a collaboration and licensing agreement with Grifols, one of the leading producers of plasma-derived medicines, to develop the treatment.3 The collaboration aimed to combine Grifols’ IG development expertise with Selagine’s advanced research and medical and clinical expertise. Grifols is funding the entire development program through FDA approval. The companies expect that the IG drops will reach retail pharmacies in early 2029.4
“We believe our immunoglobulin eye drops have the potential to make a qualitative leap in how dry eye disease is treated,” Jörg Schüttrumpf, chief scientific innovation officer at Grifols, said. “Research suggests that the broad-spectrum anti-inflammatory and immunomodulatory properties of an ocular surface IG are superior to currently approved therapies. We are using our extensive and deep knowledge of immunoglobulins to benefit the millions of patients globally who aren’t receiving sufficient relief.”3
References
Selagine, Inc. FDA Grants IND Clearance for Immunoglobulin Eye Drops to Treat Dry Eye Disease Patients in a Phase II Clinical Study. May 21, 2025. Accessed May 21, 2025. https://prnmedia.prnewswire.com/news-releases/fda-grants-ind-clearance-for-immunoglobulin-eye-drops-to-treat-dry-eye-disease-patients-in-a-phase-ii-clinical-study-302460986.html
Golden MI, Meyer JJ, Zeppieri M, et al. Dry Eye Syndrome. [Updated 2024 Feb 29]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK470411/
Grifols. Grifols enters into global collaboration and licensing agreement with Selagine to develop immunoglobulin eye drops to treat dry eye disease. March 6, 2023. Accessed May 21, 2025. https://www.grifols.com/en/view-news/-/news/grifols-enters-into-global-collaboration-and-licensing-agreement-with-selagine-to-develop-immunoglobulin-eye-drops-to-treat-dry-eye-disease
Grifols. Grifols receives FDA clearance of IND application for Phase 2 trial of immunoglobulin drops for dry eye disease. 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
