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

Market Consensus Link Securities Grifols (GRF) has been approved by the US Food and Drug Administration (FDA) for the designation of a new research drug (IND) to begin a phase 2 clinical trial that will evaluate its immunoglobulin eye drops (IGs), called the GRF312 ophthalmic solution, which could become the first indication of an GI for the treatment of eye surface pathologies, according to the Bolsamania portal. In addition, this advance [...]

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.

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

The drop has the potential to become the first-ever ocular surface indication for an IG.

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

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 fro…

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 DE…