CHICAGO, March 6,
2023 /PRNewswire/ -- Selagine, Inc., a spin-out
company from the University of Illinois at
Chicago (UIC), announced today that it has entered into a
research, development and sublicense agreement with Grifols
(Nasdaq: GRFS), a global leader in plasma-derived medicines, for
the development and commercialization of immunoglobulin eye drops
for dry eye disease.
A novel biologic eyedrop that may change
the treatment paradigm for dry eye disease
An immunoglobulin eye drop is a biologic drug that contains
naturally occurring functional antibodies generated from human
plasma collected from thousands of healthy donors. These antibodies
can neutralize inflammatory proteins such as Interferon-gamma,
Interlukin-17 and matrix metalloproteinase-9 that are implicated in
producing ocular surface disease in dry eyes. In a first-in-human
pilot clinical trial, immunoglobulin eye drops twice a day for
eight weeks caused significant reduction in signs and symptoms of
dry eyes with no difference in tolerability or adverse events as
compared to placebo. Initial developmental work for these
antibody-based biologic eye drops was performed in the Department
of Ophthalmology and Visual Sciences at the University of
Illinois College of Medicine, supported by UI Health Pharmacy,
and is the outcome of over a decade 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.
Inflammatory proteins (cytokines or chemokines), cells
(neutrophils, T-cells and dendritic cells), complement system
components and pathogenic antibodies are present on the ocular
surface in chronic dry eye disease; therefore several different
mechanisms of inflammation are simultaneously active and contribute
to symptoms and signs of dry eye disease. Immunoglobulins have
beneficial actions on each of these mechanisms; thus providing
broad-spectrum anti-inflammatory actions and potentially providing
mechanistic superiority over currently approved therapies for
chronic dry eye disease. The anti-inflammatory actions of eye drops
that are currently approved for treating chronic dry eye disease
are narrow-spectrum and limited primarily to targeting T-cell
inflammatory mechanisms.
"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," said Sandeep Jain, MD,
founder and president of Selagine and B.A. Field professor of
ophthalmology at University of Illinois
College of Medicine. "With its strategic commitment to ophthalmics
and its global leadership in immunoglobulins, we believe Grifols
provides an ideal partner for realizing Selagine's goal of
developing the full potential of plasma protein-based eye drops
across all ophthalmic indications." Dr. Jain was assisted in the
startup and development of Selagine by Michael Flavin, PhD, a research professor in the
Colleges of Medicine and Pharmacy at UIC and a staff member at the
university's Discovery Partners Institute. "Dr. Jain is the perfect
example of a physician scientist entrepreneur who is successfully
commercializing his technology," said Dr. Flavin. "The UIC College
of Medicine and the Discovery Partners Institute are supporting
stellar faculty members in advancing their exciting, cutting-edge
discoveries toward the marketplace."
"The ability for research discoveries at universities to become
therapies for patients relies upon collaboration with
biopharmaceutical companies," said Mark
Rosenblatt MD, PhD, MBA, MHA, executive dean of the
University of Illinois College of Medicine. "We are so
delighted that this novel application of immunoglobulin eye drops
to treat dry eye disease has resulted from Dr. Sandeep Jain's world-class and innovative
research work. This new sublicense agreement between Selagine and
Grifols will facilitate the continued development of this
therapeutic to potentially help the millions of patients around the
world suffering from dry eye disease."
Under the agreement, Selagine will receive an upfront payment
and annual collaboration fee. In addition, Grifols has committed to
fund the development of immunoglobulin eye drops through FDA
approval, which will be managed collaboratively by Grifols and
Selagine, including the clinical, manufacturing and regulatory
activities required for FDA approval for dry eye disease
indication. Upon commercialization, Selagine will receive tiered
royalties on net sales and milestone payments upon achievement of
certain annual sales thresholds. Selagine will share a part of the
royalties with UIC. "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,"
said Víctor Grifols Deu, co-CEO of Grifols. "We look forward to a
close working relationship that will deliver important
breakthroughs."
About Dry Eye Disease
Dry eye happens when the eyes don't make enough tears to stay
wet, or when the tears don't work correctly. This can make the eyes
feel uncomfortable, and in some cases it can also cause vision
problems. Dry eye affects millions of Americans every year,
especially older Americans and Women. Autoimmune conditions, such
as Sjogren's syndrome, Rheumatoid Arthritis, Stevens-Johnson
syndrome and ocular Graft-versus-Host-Disease are associated with a
more severe form of dry eyes. As many as one-third of patients
visiting an ophthalmology clinics report dry eye symptoms, making
it one of the most common conditions seen by ophthalmology
specialists. Dry Eye Disease is the 3rd biggest indication of the
overall ophthalmology market. The global dry eye market size is
projected to reach more than USD 6.5
billion by 2027.
For more information about Dry Eye, visit:
https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/dry-eye
About Selagine
Selagine Inc. is a clinical-stage spin-out company from the
University of Illinois at Chicago (UIC)
that is commercializing technology which was developed within the
College of Medicine, Department of Ophthalmology and Visual
Sciences. Selagine is focused on developing novel therapeutics to
help patients suffering from a variety of debilitating ocular
diseases, and to improve the quality of life in conditions where
effective therapies do not exist.
Selagine's office is located within the Illinois Medical
District and its R&D laboratory is housed in UIC's Technology
Innovation Lab, a hub for entrepreneurship and innovation at the
University.
For more information, visit www.selagine.com
CONTACT: Media Press Office, info@selagine.com,
312-526-3725
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SOURCE Selagine, Inc