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STUDY SHOWS LUMIGAN MORE EFFECTIVE THAN XALATAN.

Allergan, Inc. (NYSE:AGN) has released a three-month comparison study of LUMIGAN(TM) (bimatoprost ophthalmic solution) 0.03%, and Xalatan(R) (latanoprost) 0.005%. The data indicate that both LUMIGAN(TM) ophthalmic solution once-a-day and Xalatan(R) once-a-day lower intraocular pressure (IOP) over a 24-hour period. After three months of therapy, patients treated with LUMIGAN(TM) demonstrated lower mean intraocular pressure of approximately 1/2 to 1 mm Hg greater than the patients treated with Xalatan(R). This difference was statistically significant at the noon and 4 PM timepoints measured at month three. Both were safe and well tolerated in patients with elevated IOP associated with open- angle glaucoma or ocular hypertension.

An estimated two to three million Americans suffer from glaucoma, a condition often associated with elevated intraocular pressure leading to optic nerve damage. Although there is no cure for glaucoma, a leading cause of blindness, recent opinion from such experts as the Advanced Glaucoma Intervention Study (AGIS) investigators have suggested that achieving low levels of IOP can slow the progression of the disease.

LUMIGAN(TM) - Xalatan(R) 3-Month Comparsion

In a multicentered, randomized, investigator-masked parallel group comparison involving 232 patients with elevated IOP due to open-angle glaucoma or ocular hypertension, the efficacy and safety of LUMIGAN(TM) ophthalmic solution 0.03%, dosed once daily in the evening, was compared with that of Xalatan(R) 0.005% given once daily in the evening for three months. At the three-month visit, the mean IOP reduction provided by LUMIGAN(TM) was approximately 1/2 to 1 mm Hg greater than Xalatan(R) at the four timepoints measured. The difference was statistically significant at noon and 4 PM. These results confirm the diurnal control of intraocular pressure provided by LUMIGAN(TM) seen in other studies.

At the noon timepoint of month 3, approximately 30% of the LUMIGAN(TM)-treated patients reached target pressures of less than or equal to 15 mm Hg compared with approximately 14% of the Xalatan(R)- treated patients.

The trial results suggest that both LUMIGAN(TM) ophthalmic solution and Xalatan(R) are safe and well tolerated by patients. The most frequently reported side effect in both groups was trace to mild conjunctival hyperemia. Xalatan(R) had a higher incidence of headache and ocular stinging than LUMIGAN(TM). LUMIGAN(TM) showed a slightly higher mean score of conjunctival hyperemia than Xalatan(R). Ocular inflammation was reported in one patient in each group. There were no reported changes in iris pigmentation, but such changes could be associated with longer-term treatment. There were no treatment-related serious adverse events reported during the study. After three months of therapy, just 5% of LUMIGAN(TM) patients, and 4% of Xalatan(R) patients discontinued due to adverse events. No patients in either treatment group discontinued due to lack of efficacy.

"Allergan has a long standing commitment to bringing highly effective, innovative eye care products to patients. Data collected to date show LUMIGAN(TM) to be well positioned to meet the needs of the growing glaucoma market," said Allergan, Inc. president and CEO, David E.I. Pyott.

LUMIGAN(TM) ophthalmic solution received FDA approval on March 16, 2001 and is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of other IOP-lowering medications or insufficiently responsive (failed to achieve target IOP determined after multiple measurements over time) to another IOP-lowering medication.

About Allergan

Allergan, Inc., headquartered in Irvine, California, is a technology-driven global health care company providing eye care and specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the eye care pharmaceutical, ophthalmic surgical device, over-the-counter contact lens care, movement disorder, and dermatological markets that deliver value to their customers, satisfy unmet medical needs, and improve patients' lives.

For additional information, visit www.allergan.com or call 714/246-5571.
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Comment:STUDY SHOWS LUMIGAN MORE EFFECTIVE THAN XALATAN.
Publication:Biotech Business
Geographic Code:1USA
Date:May 1, 2001
Words:635
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