What is Simbrinza and what is it used for - brinzolamide, brimonidine?
Simbrinza is an eye drop that contains two active ingredients: brinzolamide and brimonidine tartrate. Simbrinza is used to reduce intraocular pressure (pressure inside the eye) in adult patients with ocular hypertension (high intraocular pressure) or in patients with a condition known as open angle glaucoma. Simbrinza is used when therapy with other medicinal products containing only one active ingredient has been attempted without the intraocular pressure being adequately reduced.
How is Simbrinza used - brinzolamide, brimonidine?
A drop of Simbrinza is given to the affected eye or eyes twice a day. If other eye drops are used concomitantly to reduce eye pressure, these should be administered at least 5 minutes apart. Simbrinza can only be obtained with a prescription. For more information, see the package leaflet.
How does Simbrinza - brinzolamide, brimonidine work?
Open-angle glaucoma (a condition in which the aqueous humor, that is, the fluid present inside the eyeball, cannot flow properly) and other causes of ocular hypertension increase the risk of damage to the retina and the optic nerve (the nerve that transmits signals from the eye to the brain), causing severe vision loss and even blindness. The active ingredients of Simbrinza, brinzolamide and brimonidine tartrate, promote the reduction of intraocular pressure by decreasing the production of aqueous humor. Brinzolamide works by blocking an enzyme called carbonic anhydrase, which produces the bicarbonate necessary for the production of aqueous humor, while brimonidine tartrate blocks another enzyme known as adenylate cyclase, also involved in the production of aqueous humor. Brimonidine also increases the drainage of aqueous humor from the front of the eye. Both medicines have been used separately in the EU for some years to reduce eye pressure, but their combination reduces internal pressure in the eye more effectively than monotherapy.
What benefit has Simbrinza shown - brinzolamide, brimonidine during the studies?
Simbrinza has been shown to be more effective than brinzolamide or brimonidine tartrate monotherapy in reducing eye pressure. A main study was conducted on 560 patients with ocular hypertension or open-angle glaucoma, in which the mean intraocular pressure before treatment, measured in units called mmHg, was 26 mmHg. The reduction in intraocular pressure after 3 months was greater in patients treated with Simbrinza (average reduction of 7.9 mmHg) compared to subjects treated with brinzolamide or brimonidine tartrate (6.5 and 6.4 mmHg, respectively). A second main study of 890 patients compared Simbrinza with a combined therapy of brinzolamide and brimonidine tartrate given separately in drops. Simbrinza has been shown to be as effective as combination therapy. The average reduction in intraocular pressure recorded with Simbrinza after 3 months was 8.5 mmHg compared to the reduction of 8.3 mmHg detected with the therapeutic combination.
What is the risk associated with Simbrinza - brinzolamide, brimonidine?
The most common undesirable effects found in studies with Simbrinza were conjunctival hyperemia (red eyes) and allergic reactions affecting the eye, which involved about 6-7% of patients, as well as dysgeusia (disorders of the sense of taste), which was observed in about 3% of patients. For the full list of all side effects reported with Simbrinza, see the package leaflet. Simbrinza should not be used in people who are hypersensitive (allergic) to the active substances, to any of the other substances or to sulfonamides (a class of antibiotics). It must also not be used in patients treated with certain types of antidepressants, in patients with severe impairment of renal function or in patients with hyperchloraemic acidosis (presence of excess acid in the blood, caused by an overabundant accumulation of chlorine). Treatment with Simbrinza is contraindicated in infants or children under the age of 2 years and is not recommended in children over the age of 2 years.
Why has Simbrinza - brinzolamide, brimonidine been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) has decided that Simbrinza has been shown to be more effective than the monotherapy treatment with one or the other active ingredient and at least as effective as the combination of the separately administered active ingredients as ophthalmic drops. The fact of administering both active ingredients in a single drop improves the convenience of therapy and adherence to it by patients who are not adequately controlled with brimonidine or brinzolamide administered as monotherapy. It also offers benefits to those who need a combination therapy but are not suitable for treatment with the already authorized combinations based on the medicinal product timolol. As regards safety, the undesirable effects found with Simbrinza reflected the expected events with the administration of the individual active ingredients and did not give rise to major concerns. The CHMP therefore considered that the benefits of Simbrinza outweigh the identified risks and recommended that they be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Simbrinza - brinzolamide, brimonidine?
A risk management plan has been developed to ensure that Simbrinza is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Simbrinza, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
Other information on Simbrinza - brinzolamide, brimonidine
On 18 July 2014, the European Commission issued a marketing authorization for Simbrinza, valid throughout the European Union. For more information about treatment with Simbrinza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 07-2014.
