WESTPORT, Ireland, December 11 /PRNewswire/ --
- FOR HEALTHCARE PROFESSIONAL MEDIA ONLY
Treatment with LUMIGAN(R) (bimatoprost) alone is as effective at lowering intraocular pressure (IOP) as a fixed combination of latanoprost combined with timolol (LTFC), according to a study published in Ophthalmology this month.
These are the results of a randomised, double-blind, study which set out to compare the effects of LUMIGAN(R) and LTFC over a 24-hour period on IOP, the leading risk factor for glaucoma.(2) Glaucoma is the second leading cause of blindness globally(3).
The European Glaucoma Society (EGS) guidelines outline that bimatoprost appears to be one of the effective, well-tolerated agents for the reduction of IOP in patients with primary open-angle glaucoma and ocular hypertension.(4)
Patients recruited for the study had glaucoma or ocular hypertension and were either on a non-fixed combination of latanoprost and timolol for at least 3 months or on monotherapy with either latanoprost or timolol and not fully controlled prior to enrolment.1 Those patients on a monotherapy treatment had to undergo a 6 week phase with the non-fixed combination of latanoprost and timolol before baseline IOP was determined for inclusion in the study.1 These inclusion criteria helped ensure the results demonstrate the effects of the study treatment alone, as opposed to any changes in therapy by individuals immediately prior to the study.
Patients were tested after twelve weeks of treatment with LUMIGAN(R) against patients on LTFC.1 The results from this non-inferiority study showed no significant difference between the two treatment groups; mean baseline IOPs changed from 16.3+/-3.3 mmHg to 16.1+/-2.5 mmHG in the LUMIGAN(R) group, and from 15.5+2.9 mmHG to 16.3+3.7 mmHG in the LTFC group.1 These data demonstrate that LUMIGAN is is an effective therapy in maintaining IOP at a controlled level over a 24 hour period in patients switched from the non-fixed combination of latanoprost and timolol.
Commenting on the data, Dr. Luca Rossetti, Professor of Ophthalmology, University of Milan, and lead author of the study, said, "the fact that monotherapy with bimatoprost is shown to be non inferior to a fixed combination of latanoprost/timolol in lowering IOP, indicates that LUMIGAN can be a welcome alternative to dual therapy with either a fixed or non-fixed combination of latanoprost and timolol."
LUMIGAN lowers IOP by enhancing the outflow of aqueous humour, helping it to drain through two separate pathways out of the eye.
Notes to Editors:
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LUMIGAN(R) (Bimatoprost Ophthalmic Solution) 0.03%
Abbreviated Prescribing Information
Presentation: Eye drop solution, one ml contains 0.3mg bimatoprost. Indications: Reduction of elevated intraocular pressure (IOP) in chronic open-angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers). Dosage and Administration: Please refer to the Summary of Product Characteristics before prescribing. Recommended dose is one drop in the affected eye(s) once daily, administered in the evening. More frequent administration may lessen the IOP lowering effect. If more than one topical ophthalmic medicinal product is being used, each should be administered at least 5 minutes apart. Not recommended in children or adolescents (under the age of 18). In renal or hepatic impairment use with caution. Contra-indications: Hypersensitivity to bimatoprost or any of the excipients. Warnings/Precautions: Prior to treatment patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased iris pigmentation. Some of these changes may be permanent and may lead to differences in appearance between the eyes when only one eye is treated. The change in iris pigmentation occurs slowly and may not be noticeable for several months. At 12 months, the incidence was 1.5% and did not increase following 3 years treatment. Benzalkonium chloride may be absorbed by soft contact lenses, which should be removed before instillation. The lenses may be reinserted 15 minutes after LUMIGAN(R) administration. Monitoring required with frequent or prolonged use in dry eye patients or where the cornea is compromised. Use with caution in patients with compromised respiratory function. LUMIGAN(R) has not been studied in patients with heart block more severe than first degree or in uncontrolled congestive heart failure, inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma. Cystoid macular oedema has been uncommonly reported (>1/1000 to 1/10) were growth of eyelashes (up to 45% in first year with new reports decreasing to 7% at 2 years and 2% at three years), conjunctival hyperaemia (mostly trace to mild - up to 44% in first year decreasing to 13% at 2 years and 12% at 3 years), and ocular pruritus (up to 14% in first year decreasing to 3% at 2 years and 0% at 3 years). Less than 9% of patients discontinued due to any adverse event in the first year with additional discontinuations being 3% at both 2 and 3 years. The following undesirable effects were reported as follows: Eye disorders Common (>1/100 to 1/1000 to
Legal Category: POM. Date of Preparation: November 2007.
Further information is available from: Allergan Limited, Marlow International, The Parkway, Marlow, Bucks. SL7 1YL.
Adverse events should be reported to Allergan Ltd. UK_Medinfo@allergan.com or +44(0)1628-494026
Information about adverse event reporting can be found at http://www.yellowcard.gov.uk
(1) Rossetti, L. et al. Ophthalmology. Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol on Circadian Intraocular Pressure. Volume 114, Issue 12, December 2007. 2244-2251 .e1
(2) Kobelt, G et al. Direct costs of glaucoma management following initiation of medical therapy. A simulation model based on an observational study of glaucoma treatment in Germany, 1998
(3) World Health Organization http://www.who.int/mediacentre/factsheets/fs282/en/print.html Accessed 26 October 2007
(4) European Glaucoma Society. Terminology and Guidelines for Glaucoma. 2003. 11th Edition
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