Newswise, August 10, 2016-– The Food and Drug Administration
recently approved lifitegrast, a new eye drop for treating signs and symptoms
of dry eye in adult patients.
Kelly Nichols, O.D., Ph.D., a dry eye expert and dean of
the University of Alabama at
Birmingham School of Optometry, conducted research studies for the
parent drug company to explore the efficacy and safety of lifitegrast in
treating this eye condition that affects more than 16 million adults in the
United States.
Inflammation associated with dry eye may eventually lead to
damage to the surface of the eye.
“Dry eye is a common complaint to eye care professionals, with
millions of U.S. adults experiencing the symptoms of this often chronic
disease,” Nichols said.
“It is critical for eye care professionals to have a dialogue
with patients who report symptoms because dry eye can be a progressive ocular
surface disease.”
The twice-daily eye drop solution of 5 percent lifitegrast
ophthalmic solution is the only prescription eye drop indicated for the
treatment of both signs and symptoms of dry eye, and it is the first new dry
eye prescription drop approved in the last 13 years.
Nichols and a team of researchers studied 1,181 patients, of
whom 1,067 received lifitegrast in four placebo-controlled 12-week trials.
Signs and symptoms were assessed at baseline and at weeks two, six and 12.
In all four studies, eye dryness was significantly reduced,
with two of the studies showing improvements at week two.
Results from inferior corneal staining tests — used by
physicians to detect abrasions on the cornea — showed improvement in three of
the four studies.
Nichols continues to push for funding and advancement for dry
eye research and treatment.
Prior to FDA approval of the lifitegrast eye drop, Nichols presented
a congressional briefing in Washington, D.C., addressing research into dry eye
for the National Alliance for Eye and Vision Research. She focused on the cause
and potential therapies for dry eye that are being funded through the National
Eye Institute and in private industry.
Focusing her research on all aspects of the eye, Nichols
discussed the mechanics of the three layers of the tear film and the importance
of each from the cornea outward:
• Mucin layer: helps tears adhere to the eye
• Aqueous layer or water layer: nourishes and protects the cornea
• Lipid or oil layer: lubricates and prevents evaporation and provides smooth refractive surface needed for optimal vision.
• Mucin layer: helps tears adhere to the eye
• Aqueous layer or water layer: nourishes and protects the cornea
• Lipid or oil layer: lubricates and prevents evaporation and provides smooth refractive surface needed for optimal vision.
“We are unsure which of the 200-plus different lipids and
500-plus unique proteins are most important for protecting and lubricating the
eye, and the absence or insufficiency of which results in dry eye,” Nichols
said.
There are more than 30-plus new dry eye basic, translational
and clinical studies being funded by the NEI/National Institutes of Health to
further explore these lipids and proteins, with more than 50 papers being
published monthly.
“Funding from NIH is helping the optometry world make
significant strides in understanding the cause and treatment of dry eye,”
Nichols said. “We still have a long way to go, but prevention and early
detection are major goals. There is hope for dry eye patients worldwide.”
Diagnosis of dry eye is identified by an eye care professional
based on careful evaluation of signs and symptoms, including dryness,
discomfort, vision changes and damage to the surface of the eye. Specialty
testing for dry eye is performed at the Dry Eye Relief Clinic at UAB Eye Care,
in the School of Optometry.
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