What is Lumigan?
Lumigan is a clear eye drop solution that contains the active substance bimatoprost.
What is Lumigan used for?
Lumigan is indicated to reduce the pressure inside the eye. It is used in patients with chronic open-angle glaucoma (a disease in which the pressure in the eye rises because fluid cannot flow out of the eye) and in patients with ocular hypertension (eye pressure above normal). Lumigan can be used on its own (on its own) or as an add-on to beta-blocker eye drops (other medicines used to treat these conditions).
The medicine can only be obtained with a prescription.
How is Lumigan used?
The recommended dose is one drop of Lumigan in the affected eye (s) once a day to be administered in the evening. If multiple eye drops are being used, each drug should be administered at least 5 minutes apart. on the other.
How does Lumigan work?
When the pressure inside the eye increases, it causes damage to the retina (the light-sensitive membrane at the back of the eye) and to the optic nerve (nerve that sends signals from the eye to the brain), causing severe vision loss. and even blindness. The active substance in Lumigan, bimatoprost, is a prostaglandin analog (a man-made copy of a natural substance, prostaglandin). In the eye, prostaglandin increases the drainage of the aqueous humor (clear liquid inside the eye) towards the outside. Lumigan works in the same way, increasing the flow of fluid towards the outside of the eye, therefore reducing the pressure inside the eye and the risk of damage.
How has Lumigan been studied?
Lumigan has been studied in adults with glaucoma or ocular hypertension:
- Lumigan used on its own was compared with timolol (a beta blocker used to treat glaucoma) in two 12-month studies involving a total of 1,198 patients. Some of these patients continued to take the drugs for 2 or 3 years (379 and 183, respectively). Lumigan was also compared with latanoprost (another prostaglandin analog used in the treatment of glaucoma) in a 6-month study of 269 patients;
• The efficacy of Lumigan used as add-on therapy to beta-blocker eye drops was compared with the efficacy of placebo (a dummy treatment) in combination with beta-blockers in a study involving 285 patients. The efficacy of Lumigan as an adjuvant therapy to beta-blockers was also compared with that of latanoprost in another study involving 437 patients.
In all of these studies, the main measure of effectiveness was the reduction in ocular pressure. Ocular pressure is measured in "millimeters of mercury" (mmHg). In a patient with ocular hypertension or glaucoma, this value is generally greater than 21 mmHg .
What benefit has Lumigan shown during the studies?
Lumigan given alone was more effective than timolol in lowering eye pressure. This effect was maintained even after 2 or 3 years of treatment, with a mean reduction in eye pressure ranging from 7.1 to 8.6 mmHg observed with once-daily administration of Lumigan compared with the mean reduction of 4.6 to at 6.4 mmHg found with timolol. Lumigan was also more effective than latanoprost: after six months of treatment, a reduction in eye pressure of 6.0 to 8.2 mmHg was observed in subjects treated with Lumigan, compared with a reduction of 4.9 to 7.2 mmHg detected with latanoprost.
Adding Lumigan to ongoing beta-blocker therapy was more effective than beta-blocker monotherapy. After three months of treatment with Lumigan as add-on therapy, eye pressure decreased by 7.4 mmHg, compared with a decrease in 3.6 mmHg observed in the placebo group. Lumigan was as effective as latanoprost when used as an add-on to beta-blocker treatment, with reductions in eye pressure of 8.0 and 7.4 mmHg, respectively, after three months of treatment.
What is the risk associated with Lumigan?
The most common side effects seen with the use of Lumigan (seen in more than 1 in 10 patients) are conjunctival hyperaemia (increased blood flow to the eye, which causes redness of the eye), eyelash growth and eye itching. The full list of side effects reported with Lumigan, see the package leaflet.
Lumigan must not be used in people who may be hypersensitive (allergic) to bimatoprost or any of the ingredients. Lumigan contains benzalkonium chloride, which can make soft contact lenses opaque; therefore, people who wear soft contact lenses need to be especially careful.
Why has Lumigan been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Lumigan's benefits are greater than its risks in reducing elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults (as monotherapy or as add-on therapy to beta-blockers) and therefore recommended the granting of a marketing authorization for Lumigan.
Other information about Lumigan:
On 8 March 2002, the European Commission granted Allergan Pharmaceuticals Ireland a marketing authorization valid throughout the European Union for Lumigan. The marketing authorization was renewed on 8 March 2007.
For the full version of the Lumigan EPAR click here.
Last update of this summary: 09-2009.
The information on Lumigan - eye drops published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
