Selagine, Inc. announced that the US 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 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, according to a company press release. Selegine is a spin-off company from the University of Illinois Chicago.

In chronic DED, several different mechanisms of inflammation are active simultaneously and contribute to symptoms in dry eye disease; IG eye drops have beneficial actions on each mechanism, according to the press release. The result is that IG provides broad-spectrum anti-inflammatory actions and potentially provides mechanistic superiority over currently approved therapies for chronic dry eye disease.

Selagine formed a research, development, and sublicense agreement with Grifols, the sponsor of the IND and a leader in plasma-derived medicines, in March 2023 for the development and commercialization of immunoglobulin eye drops for DED. The Selagine-Grifols sublicense agreement has since been expanded to include the treatment of chemical traumatic injuries with IG eye drops.