What is Azarga?
Azarga is an eyewash, suspension, containing two active ingredients, brinzolamide and timolol.
What is Azarga used for?
Azarga is used to reduce intraocular pressure (IOP, internal pressure of the eye). It is used in adult patients with open-angle glaucoma (a disease in which the internal pressure of the eye increases because the liquid cannot flow out of the eye) or from ocular hypertension (when the internal pressure of the eye is higher compared to the norm). Azarga is used when treatment with a medicine containing only one active ingredient has failed to sufficiently reduce IOP.
The medicine can only be obtained with a prescription.
How is Azarga used?
Azarga is given with one drop in the affected eye (s) twice a day. The suspension must be shaken well before use.
How does Azarga work?
IOP elevation causes damage to the retina (the light-sensitive surface located at the back of the eye) and to the optic nerve that transmits signals from the eye to the brain. This can lead to severe vision loss and even blindness. By lowering the pressure, Azarga reduces the risk of damage.
Azarga contains two active ingredients, brinzolamide and timolol. The two substances act by reducing the production of aqueous humor (the aqueous liquid inside the eye) in different ways. Brinzolamide is a carbonic anhydrase inhibitor that works by blocking an enzyme called carbonic anhydrase, which produces bicarbonate ions in the body. Bicarbonate is necessary for the production of aqueous humor. Brinzolamide has been authorized in the European Union (EU) under the Azopt brand since 2000. Timolol is a beta-blocker commonly used for the treatment of glaucoma since the 1970s.
The combined action of the two substances is superior to that of the individual substances used alone.
What studies have been carried out on Azarga?
The effects of Azarga were first tested in experimental models before being studied in humans.
Azarga has been tested in two main studies involving a total of 960 adults with open-angle glaucoma or ocular hypertension. The first was a six-month study on the comparison of Azarga with brinzolamide and with timolol used alone in 523 patients. The second was a 12-month study on the comparison of Azarga with the combination of timolol and dorzolamide (another carbonic anhydrase inhibitor) in 437 patients. In both studies, the main measure of effectiveness was the change in IOP in the first six months of therapy. IOP was measured in 'millimeters of mercury' (mmHg).
What benefit has Azarga shown during the studies?
Azarga was more effective than the individual active ingredients used alone and showed an efficacy equivalent to that of the combination of timolol and dorzolamide. In the first study, IOP was reduced from about 21 mmHg to 8.0 - 8.7 mmHg in patients using Azarga. These reductions were compared with 5.1 - 5.6 mmHg of those using brinzolamide and 5.7 - 6.9 mmHg of those using timolol. In the second study, IOP had dropped from about 26 mmHg to 8.3 mmHg approximately after six months in both patient groups.
What is the risk associated with Azarga?
The most common side effects of Azarga (seen in between 1 and 10 patients in 100) are dysgeusia (bitter or strange taste in the mouth), blurred vision, eye pain, eye irritation and foreign body sensation in the eyes. For the full list of all side effects reported with Azarga, see the Package Leaflet.
Azarga should not be used in people who may be hypersensitive (allergic) to the active substances, to any of the other substances, to other beta-blockers (eg some heart medicines) or to sulfonamides (eg some antibiotics) . The medicine should not be used by patients who:
- they had asthma;
- suffer from a severe form of chronic obstructive pulmonary disease (a disease that causes narrowing of the airways);
- have certain heart problems;
- have a severe allergy involving the nose and airways;
- have hyperchloraemic acidosis (excess acidity in the blood caused by too much chloride);
- have serious kidney problems.
For the full list of usage restrictions, see the package leaflet.
Azarga contains benzalkonium chloride, which causes discoloration of soft contact lenses. Therefore, people who wear soft contact lenses should be careful.
Why has Azarga been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that the combination of the two active ingredients of Azarga simplifies therapy and helps patients to stick to treatment. The committee determined that the benefits of Azarga outweigh its risks for IOP reduction in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy does not guarantee sufficient PIO reduction. The committee recommended that Azarga be given marketing authorization.
More information on Azarga:
On 25 November 2008, the European Commission issued a marketing authorization valid for Azarga throughout the European Union to Alcon Laboratories (UK) Ltd.
For the full EPAR of Azarga, click here.
Last update of this summary: 10-2008.
