The potential treatment, after completing clinical development and receiving regulatory authorizations, would become Grifols’ first ocular-surface indicated medicine. The company says it would also be its first-ever product for dry eye disease, which affects more than 100 million people around the world.
Under the terms of the agreement, Grifols will have worldwide exclusive commercial rights to Selagine’s treatment once it receives the regulatory authorization, expected in early 2029.
To see how well it works and how well the product is tolerated as an anti-inflammatory, it will go through a clinical development program.
Grifols says it will use its expertise to develop and manufacture Ig therapies alongside Selagine’s research, medical knowledge and clinical experience with treating debilitating eye disease.
New product in pharmacies
The companies hope that a new product will reach retail pharmacies in early 2029.
In a pilot phase 1/2 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.
Selagine says that 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.
The company says its 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.
Change the paradigm of dry eye treatment
“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,” said Sandeep Jain, MD, founder and president of Selagine.
The companies agreed that Grifols will fund the entire clinical development program through approval by the U.S. Food and Drug Administration, (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. 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.
“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.”