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The US Food and Drug Administration (FDA) has cleared Grifols' investigational new drug (IND) application to initiate a Phase II trial of GRF312 Ophthalmic Solution, an immunoglobulin (IG) eye drop, as a potential treatment for dry eye disease (DED).
DED is a prevalent inflammatory condition marked by insufficient moisture on the outer surface of the eye. In severe cases, it can cause permanent vision damage.
IG eye drops are said to be derived from pooled human plasma from healthy donors.
The latest trial will assess the efficacy, safety, and tolerability of the treatment in 100 DED subjects.
It is anticipated to start in the third quarter of this year and build on the pilot Phase I/II trial conducted at the University of Illinois College of Medicine (UI COM), Department of Ophthalmology, by Grifols' partner and UIC spin-out company Selagine.
Findings from the study indicated that subjects, when treated two times a day with eye drops based on Grifols' IG product for eight weeks, showed a decrease in signs and symptoms of DED without any difference in tolerability being observed.
In a collaborative effort, Grifols will leverage its expertise in IG therapies and Selagine's research and clinical experience in eye conditions.
Established in March 2023, the partnership grants Grifols exclusive global rights to Selagine's treatment.
The IG eye drops’ initial development was carried out by the Department of Ophthalmology & Visual Sciences at the UI COM and Loyola University.
This initiative received support from UI Health Pharmacy and funding from the National Eye Institute, Research to Prevent Blindness, and UIC's Office of Technology Management.
The sublicense agreement between the companies has expanded to include the chemical traumatic injury treatment by using IG eye drops.
Grifols' chief scientific innovation officer Dr Jörg Schüttrumpf said: “We believe our immunoglobulin eye drops have the potential to make a qualitative leap in how dry eye disease is treated.
“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.”
In July 2023, Grifols completed subject enrolment for its Phase III PRECIOSA clinical trial investigating the use of long-term Albutein therapy to extend survival time in those with decompensated cirrhosis.
"FDA clears Grifols’ application for dry eye disease treatment" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.