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LUMIGAN Outcome Favorable in Comparison Study with Xalatan; LUMIGAN - Xalatan Comparison Presented at International Glaucoma Symposium
Business Wire, March 24, 2001
Business Editors & Health/Medical Writers
PRAGUE, Czech Republic--(BW HealthWire)--March 24, 2001
Allergan, Inc. (NYSE:AGN) released a three-month comparison study of LUMIGAN(TM) (bimatoprost ophthalmic solution) 0.03%, and Xalatan(R) (latanoprost) 0.005% today at the Third Annual International Glaucoma Symposium (IGS) in Prague. 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.
Forward-looking Statements
This press release contains "forward-looking statements," such as statements regarding the safety and effectiveness of LUMIGAN(TM) ophthalmic solution and Allergan's on-going commitment to bringing new products to patients. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations. Risks and uncertainties inherent in successfully bringing new products to market include general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in new product marketing such as the unpredictability of market acceptance for a new pharmaceutical product; potential difficulties in manufacturing a new product formulation; and governmental laws and regulations. Allergan cautions that the protocol for this three-month study has not been approved by the U.S. Food and Drug Administration. A longer term study may show different results. Additional information concerning these and other risk factors can be found in press releases issued by Allergan as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Certain Factors and Trends Affecting Allergan and Its Businesses" in Allergan's 2000 Annual Report on Form 10-K. Allergan's filings are available publicly and upon request from Allergan's Investor Relations Department: 714.246.4636 or http://www.allergan.com. Allergan is disseminating this press release in order to comply with Securities and Exchange Commission requirements under Regulation FD in the event that the clinical data are deemed material to its investors.
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