Selagine has signed a research, development and sublicense agreement with Grifols for the development and commercialisation of immunoglobulin eye drops for dry eye disease.
Selagine is a spin-out company from the University of Illinois at Chicago (UIC), while Grifols is a provider of plasma-derived medicines.
A biologic drug, an immunoglobulin eye drop features naturally occurring functional antibodies produced from human plasma gathered from thousands of healthy donors.
These antibodies are capable of neutralising inflammatory proteins, such as Interferon-gamma, Interlukin-17 and matrix metalloproteinase-9 that are implicated in generating ocular surface disease in dry eyes.
In a first-in-human pilot clinical trial, immunoglobulin eye drops twice a day for eight weeks led to a huge reduction in signs and symptoms of dry eyes with no difference found in tolerability or adverse events as against placebo.
The initial developmental work for these antibody-based biologic eye drops was undertaken in the Department of Ophthalmology and Visual Sciences at the University of Illinois College of Medicine, supported by UI Health Pharmacy.
It is the result of more than ten years of research and development efforts, with grant funding from the National Eye Institute (NEI)/National Institutes of Health (NIH), Research to Prevent Blindness and UIC’s Office of Technology Management.
As per the agreement, Selagine will get an upfront payment and annual collaboration fee.
Furthermore, Grifols has made a commitment to fund the development of immunoglobulin eye drops via FDA approval, which will be collaboratively managed by the two entities, including the clinical, manufacturing and regulatory activities needed for FDA approval for dry eye disease indication.
Following commercialisation, Selagine will get tiered royalties on net sales and milestone payments on achieving some annual sales thresholds.
Selagine will in turn share a part of the royalties with UIC.
Grifols co-CEO Víctor Grifols Deu said: “Grifols is extremely pleased to drive ophthalmological innovation to help patients, combining our industry-leading knowledge of immunoglobulins with Selagine’s life-changing research and therapeutics to treat eye diseases. We look forward to a close working relationship that will deliver important breakthroughs.”
Selagine founder, managing director, president Sandeep Jain said: “This collaboration builds upon complementary expertise of the two companies to provide a clear pathway to completing development and regulatory activities and executing a successful commercial launch of immunoglobulin eye drops for chronic dry eye disease indication.”