FDA Clears Grifols' IND for Phase 2 Trial of Dry Eye Disease Treatment

GRFS
October 08, 2025

The U.S. Food and Drug Administration (FDA) has cleared Grifols' Investigational New Drug (IND) application for a Phase 2 clinical trial. This clearance pertains to its immunoglobulin (IG) drops, which are being developed as a treatment for dry eye disease (DED).

The upcoming trial is designed to assess the efficacy, safety, and tolerability of the treatment in a cohort of 100 subjects diagnosed with DED. This advancement into Phase 2 represents a critical step in the clinical development process for this novel therapeutic.

This regulatory milestone is part of Grifols' broader commitment to innovation and expanding its portfolio of specialized therapies. The successful progression of this trial could lead to a new treatment option for patients suffering from dry eye disease.

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