Grifols, a producer of plasma-derived medicines, entered a global collaboration and licensing agreement with Selagine Inc, a company focused on developing novel therapeutics for ocular diseases, to treat dry eye disease (DED) with immunoglobulin eye drops.
 
The potential Ig treatment, following clinical development and regulatory authorizations, would become Grifols’ first ocular-surface indicated medicine as well as the company’s first-ever product for DED, which affects more than 100 million people globally.
 
Under terms of the agreement, Grifols will have worldwide exclusive commercial rights to Selagine’s treatment, which will be developed combining Grifols’ expertise in developing and manufacturing innovative Ig therapies and Selagine’s cutting-edge research, medical expertise and clinical experience treating debilitating eye diseases.
 
“Grifols is very excited to combine our synergistic strengths with Selagine in a potentially game-changing treatment for an unmet medical need that can help millions of patients globally with dry eye disease,” said Victor Grifols Deu, co-CEO of Grifols. “We are committed to maximizing our deep and ever-growing knowledge of immunoglobulins to treat the broadest range of therapeutic areas.”
 
Sandeep Jain, founder and president of Selagine and BA Field Professor of Ophthalmology at the University of Illinois Chicago said: “Selagine and Grifols have an exceptional opportunity to change the paradigm of dry eye treatment through a novel approach that has the potential to significantly improve the quality of life of patients suffering from this condition.” 
 
In a pilot phase I/II clinical trial, Selagine treated subjects with eye drops based on Grifols Flebogamma DIF twice daily for eight weeks and secured a significant reduction in the signs and symptoms of DED, and with no difference in tolerability or adverse events.
 
Several different sources of inflammation, including proteins (cytokines or chemokines), cells (neutrophils, T-cells and dendritic cells) and pathogenic antibodies, are present on the ocular surface in DED and contribute to its signs and symptoms. Selagine’s line of research is that the broad-spectrum anti-inflammatory actions of an ocular surface immunoglobulin are superior to currently approved therapies, which are narrow spectrum and limited mainly to targeting T-cell inflammatory mechanism.

Grifols will fund clinical development through approval by the U.S. FDA, which will be managed jointly by both companies. This includes the clinical, manufacturing and regulatory activities required for FDA approval for an indication for dry eye disease. 

In addition, Grifols would sub-license the potential treatment and make tiered royalty payments based on net sales as well as milestone payments upon achievement of certain annual sales thresholds.