Grifols Enters Into Global Collaboration and Licensing Agreement with Selagine to Develop Immunoglobulin Eye Drops to Treat Dry Eye Disease

Spanish pharma company Grifols announced a global collaboration and licensing agreement with Selagine to treat dry eye disease (DED) with immunoglobulin eye drops.

Financial terms of the deal were not disclosed. 

The potential immunoglobulin treatment would be Grifols’ first ocular-surface indicated medicine as well as the company’s first product for DED, which affects more than 100 million people globally. Under their agreement, Grifols to have worldwide exclusive commercial rights to Selagine’s treatment upon regulatory authorization, expected in early 2029. Grifols will fund the clinical development program through approval by the FDA, which will be managed jointly by both companies. 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.

In a pilot phase 1/2 clinical trial, Selagine treated subjects with eye drops based on Grifols Flebogamma DIF twice daily for 8 weeks and secured a significant reduction in the signs and symptoms of DED, and with no difference in tolerability or adverse events, according to a company news release.

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 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,” Victor Grifols Deu, co-CEO of Grifols, said in a company news release. “We are committed to maximizing our deep and ever-growing knowledge of immunoglobulins to treat the broadest range of therapeutic areas.”