Study Of Lacrisert(R) Dry Eye Insert Published In The Ocular Surface

Main Category: Eye Health / Blindness
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 20 Aug 2009 - 2:00 PDT

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Aton Pharma, Inc. announced that The Ocular Surface, a leading peer-reviewed ophthalmology journal, has published an article that includes results of a retrospective case series study of dry eye patients using Lacrisert(R) (hydroxypropyl cellulose ophthalmic insert). The article, "Extending the Duration of Tear Film Protection: Review and Retrospective Case Series Study of the Hydroxypropyl Cellulose Ophthalmic Insert," by Arden H. Wander, M.D. and Bruce H. Koffler, M.D., discusses how the duration of tear film protection in dry eye patients can be extended using artificial tear formulations with enhanced viscosity/polymeric systems, the hydroxypropyl cellulose insert and other approaches.

Lacrisert 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.

"Our retrospective case series indicates that the hydroxypropyl cellulose ophthalmic insert can be a valuable treatment for dry eye patients, either alone or in conjunction with other therapies," concluded Dr. Koffler. "The reports of symptom improvement and extremely low rate (2.5%) of adverse effects suggest that the inserts are an appropriate long-term therapy. The fact that so many patients had been using the inserts for more than 5 years suggests that it is a relatively safe, tolerable, and effective therapy."

"This is the first peer-review publication for Lacrisert in more than two decades," stated Michael G. Wells, Chief Executive Officer of Aton Pharma. "Pursuing scientific and clinical publications is part of our commitment to contributing to physician knowledge of Lacrisert."

Recently, results of a large (n = 520) multi-center patient registry study of the Lacrisert insert were presented during the 2009 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) and the 145th Annual Meeting of the American Ophthalmological Society (AOS).

Findings of the Lacrisert Retrospective Study

Key findings of the Lacrisert retrospective case series study published in the July 2009 edition of The Ocular Surface include:

-- Of the 80 study patients, 73 (91%) were currently using the insert. Among those, 57 (78.1%) used the insert once a day, and 11 (15.1%) used the insert twice a day.

-- Length of therapy with the insert ranged from 10 days to over 26 years. The median length of therapy was 5.3 years. Fifty-two patients (65%) had used the inserts for over 2 years.

-- Overall, 72.6% of patients currently using the insert (N = 73) demonstrated improvement in symptoms. In eight patients (11%) symptoms were controlled. Only one patient reported no change.

-- Five patients (6.2%) wore contact lenses. All five patients were still using the insert as of the evaluation date, and four of these had been classified as having severe keratitis. The keratitis was improved in all five contact lens patients since the date of first diagnosis.

Some patients may require the flexibility of twice-daily dosing for optimal results.

Study Methodology

A retrospective case series study from 9 different ophthalmic practices of 80 dry eye patients prescribed the hydroxypropyl cellulose ophthalmic insert in the previous 2 years was performed. The purpose of the study was to identify the demographics and etiology of patients treated and to determine whether patients who used the insert experienced improvement in symptoms. Data were abstracted from patient medical records using a standardized paper form by research nurses employed by each office or by a HIPAA-certified nurse. The study was approved and monitored by the Sterling Institutional Review Board of Atlanta, Georgia. Support for the study was provided by Aton Pharma, Inc.

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.

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.

Source: Aton Pharma, Inc