What is it?

Azarga is an eye drop suspension that contains two active substances, brinzolamide and timolol.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Azarga is used to reduce intra-ocular pressure (IOP, pressure inside the eye). It is used in adults with open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) or ocular hypertension (when the pressure in the eye is higher than normal). Azarga is used when treatment with a medicine containing only one active substance has been tried but has not reduced the IOP sufficiently.
The medicine can only be obtained with a prescription.

How is it used?

Azarga is given as one drop into the affected eye(s) twice a day. The suspension needs to be shaken well before use.

How does it work?

Raised IOP causes damage to the retina (the light-sensitive surface at the back of the eye) and to the optic nerve that sends signals from the eye to the brain. This can result in serious vision loss and even blindness. By lowering the pressure, Azarga reduces the risk of damage.
Azarga contains two active substances, brinzolamide and timolol. The two substances work by reducing the production of the aqueous humour (the watery fluid in 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 required for the production of the aqueous humour. Brinzolamide has been authorised in the European Union (EU) as Azopt since 2000. Timolol is a beta-blocker that has been commonly used to treat glaucoma since the 1970s. The combined effect of the two substances is greater than either substance used alone.

How has it been studied?

The effects of Azarga were first tested in experimental models before being studied in humans. Azarga has been studied in two main studies involving a total of 960 adults with open-angle glaucoma or ocular hypertension. The first was a six-month study comparing Azarga with brinzolamide and with timolol used on their own in 523 patients. The second was a 12-month study comparing 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 over the first six months of treatment. IOP was measured in ?millimetres of mercury? (mmHg).

What benefits has it shown during the studies?

Azarga was more effective than either of the active substances used alone and was as effective as the combination of timolol and dorzolamide. In the first study, IOP fell from around 21 mmHg by 8.0 to 8.7 mmHg in the patients using Azarga. This compared with 5.1 to 5.6 mmHg in those using brinzolamide and 5.7 to 6.9 mmHg in those using timolol. In the second study, IOP had fallen from around 26 mmHg by around 8.3 mmHg after six months in both groups of patients.

What is the risk associated with Azarga The most common side effects with Azarga seen in between 1 and 10 patients in 100 are dysgeusia a bitter or unusual taste in the mouth, blurred vision, eye pain, eye irritation and the sensation of a foreign body in the eyes. For the full list of all side effects reported with Azarga, see the Package Leaflet. Azarga should not be used in patients who may be hypersensitive allergic to the active substances, any of the other ingredients, other beta-blockers such as some heart medicines or sulphonamides such as some antibiotics. It must not be used by patients who have had asthma have severe chronic obstructive pulmonary disease a disease causing narrowing of the airways have certain heart problems have a severe allergy affecting the nose and airways have hyperchloraemic acidosis excess acid in the blood caused by too much chloride have severe kidney problems. For the full list of restrictions, see the Package Leaflet. Azarga contains benzalkonium chloride, which is known to discolour soft contact lenses. Therefore, care should be taken by people who wear soft contact lenses.

What is the risk associated?

Azarga was more effective than either of the active substances used alone and was as effective as the combination of timolol and dorzolamide. In the first study, IOP fell from around 21 mmHg by 8.0 to 8.7 mmHg in the patients using Azarga. This compared with 5.1 to 5.6 mmHg in those using brinzolamide and 5.7 to 6.9 mmHg in those using timolol. In the second study, IOP had fallen from around 26 mmHg by around 8.3 mmHg after six months in both groups of patients.

What is the risk associated with Azarga The most common side effects with Azarga seen in between 1 and 10 patients in 100 are dysgeusia a bitter or unusual taste in the mouth, blurred vision, eye pain, eye irritation and the sensation of a foreign body in the eyes. For the full list of all side effects reported with Azarga, see the Package Leaflet. Azarga should not be used in patients who may be hypersensitive allergic to the active substances, any of the other ingredients, other beta-blockers such as some heart medicines or sulphonamides such as some antibiotics. It must not be used by patients who have had asthma have severe chronic obstructive pulmonary disease a disease causing narrowing of the airways have certain heart problems have a severe allergy affecting the nose and airways have hyperchloraemic acidosis excess acid in the blood caused by too much chloride have severe kidney problems. For the full list of restrictions, see the Package Leaflet. Azarga contains benzalkonium chloride, which is known to discolour soft contact lenses. Therefore, care should be taken by people who wear soft contact lenses.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) noted that combining the two active substances in Azarga simplifies therapy and helps patients to stick to their treatment. The Committee decided that Azarga?s benefits are greater than its risks for the decrease of IOP in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction. The Committee recommended that Azarga be given marketing authorisation.

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