LAWRENCEVILLE, NJ--(Marketwire - May 04, 2009) - Aton Pharma, Inc. announced today that
results from a large (n = 520) multi-center patient registry study of its
Lacrisert® ophthalmic insert will be presented this week during the 2009
Annual Meeting of the Association for Research in Vision and Ophthalmology
(ARVO), May 3-7, Ft. Lauderdale, FL, and later in the month at the 145th
Annual Meeting of the American Ophthalmological Society (AOS), May 14-17,
Half Moon Bay, CA. Lacrisert (hydroxypropyl cellulose ophthalmic insert) is
a preservative-free, once-daily*, sustained release prescription insert
indicated for moderate to severe dry eye, that helps to retain moisture,
stabilize the tear film, and lubricate the eye.
"This is the first major study of Lacrisert to be undertaken in more than
two decades," stated Michael G. Wells, Chief Executive Officer of Aton
Pharma. "Our commitment to expanding product availability and increasing
physician awareness and knowledge of Lacrisert includes gathering of key
efficacy data such as through this study."
The multi-center, 2-visit, open label, 4-week study was conducted to
determine both physician and patient acceptability and ease of use of
Lacrisert in adult patients with a history of dry eye syndrome. It was
hypothesized that patients would experience improvements in their overall
quality of life as well as in measures of dry eye signs and symptoms. A
patient registry study is designed to examine a wide range of correlations
and show predictive relationships, providing a rich resource of data to
mine over time.
Association for Research in Vision and Ophthalmology (ARVO)
Bruce H. Koffler, M.D., will present data from the study in a poster at
ARVO, "LACRISERT® (hydroxypropyl cellulose ophthalmic insert)
Significantly Improves Symptoms of Dry Eye Syndrome and Patient Quality of
Life" (Bruce H. Koffler for the LAC-07-01 Study Group, poster 4660/D904,
Wednesday, May 6, 1:45-3:30 PM).
As reported by Dr. Koffler, mean ocular surface disease index (OSDI) total
scores for patients in the study significantly improved by more than 21%
over the four weeks of the study; this was over and above any improvement
patients may have gained from previous dry eye therapies administered
before the study.
Treatment with Lacrisert also resulted in significant improvement in mean
occurrence of discomfort in heated areas (P < 0.0001) and significant
improvements when performing housework (P = 0.0018). Patients reported
significant reductions in mean severity of DES symptoms (P < 0.0001). The
most commonly reported adverse event leading to discontinuation was blurred
vision, observed in 8.7% of patients.
"The study shows use of Lacrisert results in significant improvements in
DES symptoms, in activities of daily living, and in patient quality of
life," explained Dr. Koffler. "The greater than 21% improvement in mean
OSDI total scores in this study in four weeks is especially noteworthy,
suggesting that ocular health and quality of life for dry eye sufferers can
be meaningfully improved by use of the insert in a relatively short time."
A second poster at ARVO based on the patient registry study, "Effect of
Lacrisert® on the Signs and Symptoms of Dry Eye in Contact Lens Wearers"
(Wednesday, May 6, 2009, 1:45 PM - 3:30 PM, Hall B/C) will be presented by
Stephen J. Curwen et al of Ophthalmic Research Associates (ORA). This
poster focuses on a sample subset of 30 contact lens wearers with a history
of dry eye.
The 30 contact lens patients reported significant improvements in dryness
(P = < 0.0001) and grittiness (P = 0.008) after 4 weeks of dosing with
Lacrisert when compared to baseline. Mean TFBUT increased from 2.98 to 4.08
sec. (P < 0.0001) and mean corneal/conjunctival staining decreased from
1.21 to 0.79 units (P < 0.0001). Investigators reported that 70% of
subjects experienced an improvement of dry eye symptoms and 53% experienced
an improvement in dry eye signs while wearing contact lenses. It was also
reported that Lacrisert was longer lasting 93% of the time when compared to
rewetting solutions.
"The data in this study show that Lacrisert relieves the signs and symptoms
of dry eye in contact lens wearers with a history of dry eye," concluded
the ORA investigators. "Patients experienced significant improvements in
tear film stability as well as ocular surface damage. Lacrisert may be
longer-lasting than other available treatments."
American Ophthalmological Society (AOS)
Marguerite McDonald, M.D., F.A.C.S., will present additional data from the
study in a presentation at AOS, "LACRISERT® (hydroxypropyl cellulose
ophthalmic insert) Reduces the Signs and Symptoms of Dry Eye Syndrome (DES)
and Improves Patient Quality of Life" (Marguerite McDonald, Gerard
D'Aversa, Henry Perry, John Wittpenn and Eric Donnenfeld for the LAC-07-01
Study Group, Saturday, May 16).
Dr. McDonald reports that patients experienced significant improvements in
discomfort, burning, dryness, grittiness, stinging, and light sensitivity
(P < 0.0001) after 4 weeks of treatment with Lacrisert. Overall, 57% of
subjects experienced an improvement of dry eye symptoms and 54% in clinical
signs (including Schirmers Test, conjunctival staining and TFBUT).
"The study shows Lacrisert significantly reduces symptoms and clinical
signs of moderate to severe dry eye, which is borne out by my own clinical
experience as well," stated Dr. McDonald.
Registry Study Methodology
In the Lacrisert study, at visit 1, patients (n = 520) were given a general
dry eye evaluation, screened by slit-lamp biomicroscopy and best corrected
visual acuity, and were required to fill out a questionnaire that included
the ocular surface disease index (OSDI), a validated measure of quality of
life. Patients were trained on the proper insertion and use of the insert.
Patients were contacted by telephone on Day 3 of the study for follow up
and reinstruction. At visit 2 (Week 4), patients were given a clinical
evaluation and required to complete a second evaluation. Answers provided
on questionnaires (scored on Likert-type scales) were used to determine
changes in patient-reported outcomes such as symptoms and quality of life.
About Lacrisert
Lacrisert has been FDA-approved for use in patients with moderate to severe
dry eye and available by prescription for more than two decades. Unlike
artificial tear substitutes that have a residence time measured in minutes,
Lacrisert provides continual lubrication and protection to the surface of
the eye for all-day relief. Lacrisert acts to stabilize and thicken the
pre-corneal tear film and prolong the tear film breakup time, which is
usually accelerated in patients with dry eye states. Information and
educational video content are available at www.Lacrisert.com.
Most adverse reactions with Lacrisert were mild and transient and included
transient blurring of vision, ocular discomfort or irritation, matting or
stickiness of eyelashes, photophobia, hypersensitivity, edema of the
eyelids and hyperemia. Lacrisert should not be used by patients who are
hypersensitive to hydroxypropyl cellulose. If improperly placed, Lacrisert
may result in corneal abrasion.
About Aton Pharma, Inc.
Aton Pharma, Inc., headquartered in Lawrenceville, NJ, is a global,
diversified specialty pharmaceutical company providing essential treatments
for under-treated diseases. Aton's mission is to improve patient outcomes
and quality of life worldwide by enhancing and expanding access and
availability of medically essential therapeutics. Aton's portfolio of ten
products, with sales in over 30 countries, focuses on ophthalmic diseases,
orphan conditions and acute care hospital products. For more information,
see www.atonrx.com.
* Some patients may require the flexibility of twice-daily dosing for
optimal results.
