Aton Pharma, Inc.
Significant Ocular Surface Disease Improvements Observed In Contact Lens Wearers, Post-Cataract Surgery and Post-Refractive Surgery Patients
Lawrenceville, NJ – April 7, 2010 – Aton Pharma, Inc. announced today that results from a large multi-center patient registry study of its Lacrisert® ophthalmic insert will be presented this week during World Cornea Congress IV (April 7-9, Boston). Lacrisert (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.
Bruce H. Koffler, M.D., will present data from the study in a poster at World Cornea Congress, “Efficacy and Acceptability of Hydroxypropyl Cellulose Ophthalmic Inserts: Subsets of Patients with Dry Eye Syndrome in a Patient Registry” (Poster # 772, posters available on demand on computer kiosks throughout the meeting).
A multicenter, open-label, prospective registry study enrolled 520 patients with bilateral moderate-to-severe dry eye syndrome. Clinical examinations and patient questionnaires incorporating the Ocular Surface Disease Index (OSDI) assessed clinical signs, average symptom severity and frequency, limitations on activities of daily living, and ocular discomfort in various environments one month before baseline and after one month of treatment. The inserts were used alone or with existing therapy. 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.
Within 418 completers, OSDI scores improved significantly (P<.05) in contact lens wears (23.2%), prior cataract surgery (29.2%), and prior refractive surgery (19.5%) subgroups. Blurred vision was the most commonly reported adverse effect (8.7%).
“The study shows use of Lacrisert results in significant improvements in DES symptoms, in these key subgroups,” explained Dr. Koffler. “The 20 percent-plus improvements in mean OSDI total scores in four weeks are especially noteworthy, suggesting that ocular health for these subgroups of dry eye sufferers can be meaningfully improved by use of the insert in a relatively short time.”
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.
Lacrisert is indicated in patients with moderate to severe dry eye syndromes, including keratoconjunctivitis sicca. Lacrisert is indicated especially in patients who remain symptomatic after an adequate trial of therapy with artificial tear solutions. Lacrisert should not be used by patients who are hypersensitive to hydroxypropyl cellulose. Instructions for inserting and removing Lacrisert should be carefully followed. If improperly placed Lacrisert may result in corneal abrasion. 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. Full prescribing information can be found at www.lacrisert.com.
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.
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* Some patients may require the flexibility of twice-daily dosing for optimal results.