Azopt

Active Substance: brinzolamide
Common Name: brinzolamide
ATC Code: S01EC04
Marketing Authorisation Holder: Alcon Laboratories (UK) Ltd.
Active Substance: brinzolamide
Status: Authorised
Authorisation Date: 2000-03-09
Therapeutic Area: Ocular Hypertension Glaucoma, Open-Angle
Pharmacotherapeutic Group: Ophthalmologicals

Therapeutic Indication

Azopt is indicated to decrease elevated intraocular pressure in:

  • ocular hypertension;
  • open-angle glaucomaas monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues.

What is Azopt?

Azopt is a white eye-drop suspension that contains the active substance brinzolamide.

What is Azopt used for?

Azopt is used to reduce the pressure inside the eye. It is used in patients with ocular hypertension (when the pressure in the eye is higher than normal) or open-angle glaucoma (a disease in which the pressure inside the eye rises because fluid cannot drain out of the eye). Azopt is used as an add-on to beta-blockers or prostaglandin analogues (other medicines used for these conditions), or on its own in patients who cannot take or do not respond to beta-blockers.

The medicine can only be obtained with a prescription.

How is Azopt used?

The dose of Azopt is one drop into the affected eye(s) twice a day. Some patients may have a better response with one drop three times a day. The suspension needs to be shaken before use. If more than one type of eye-drop medicine is being used, each one should be given at least five minutes apart.

How does Azopt work?

Raised pressure inside the eye causes damage to the retina (the light-sensitive surface at the back of the eye) and to the optic nerve (the nerve that sends signals from the eye to the brain). This can result in serious loss of vision and even blindness. By lowering the pressure, Azopt reduces the risk of damage to these structures.

The active substance in Azopt, brinzolamide, is a carbonic-anhydrase inhibitor. It 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 (the watery fluid in the eye). By blocking the production of bicarbonate in the eye, Azopt slows down the production of aqueous humour, reducing the pressure inside the eye.

How has Azopt been studied?

Azopt has been studied in seven main studies including a total of 2,173 patients with open-angle glaucoma or ocular hypertension. In three of the studies, Azopt, used on its own two or three times a day, was compared with timolol (a beta-blocker) and with dorzolamide (another carbonic-anhydrase inhibitor). Two of the studies compared adding Azopt, dorzolamide or placebo (a dummy treatment) to timolol, and the final two studies compared Azopt used twice a day with timolol, when they were used as an add-on to travoprost (a prostaglandin analogue). All of the studies lasted for three months, except for the study comparing Azopt used on its own with timolol, which lasted for 18 months. In all of the studies, the main measure of effectiveness was the change in pressure inside the eye measured in ‘millimetres of mercury’ (mmHg). The eye pressure was at least 21 mmHg in all of the patients at the start of the studies.

What benefit has Azopt shown during the studies?

When used on its own, Azopt was less effective than timolol. Azopt caused a reduction in eye pressure of between 2.7 and 5.7 mmHg over 18 months, compared with a reduction of between 5.2 and 6.0 mmHg with timolol.

Azopt was as effective as dorzolamide when used on its own or as an add-on to timolol, with decreases in pressure of between 3.4 and 5.7 mmHg. Dorzolamide led to decreases of between 4.3 and 4.9 mmHg. Azopt was also more effective than placebo when used as an add-on to timolol.

When used as an add-on to travoprost, Azopt had a similar effect to timolol in reducing eye pressure. In both studies, adding either Azopt or timolol caused a further decrease in eye pressure of around 3.5 mmHg after 12 weeks.

Overall, Azopt showed a similar effect when used two or three times a day. However, the results suggested that some patients may show a greater reduction in eye pressure when using the drops three times a day.

What is the risk associated with Azopt?

The most common side effects with Azopt (seen in between 1 and 10 patients in 100) are dysgeusia (a bitter or unusual taste in the mouth), headache, blepharitis (inflammation of the eyelids), blurred vision, eye irritation, eye pain, dry eye, eye discharge, eye pruritus (itching), sensation of a foreign body in the eyes, ocular hyperaemia (red eye) and dry mouth. For the full list of all side effects reported with Azopt, see the package leaflet.

Azopt should not be used in people who may be hypersensitive (allergic) to brinzolamide or any of the other ingredients, or to sulphonamides (such as some antibiotics). It must not be used in patients with severe kidney disease or hyperchloraemic acidosis (excess acid in the blood caused by too much chloride). Azopt 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 Azopt been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Azopt’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Azopt

The European Commission granted a marketing authorisation valid throughout the European Union for Azopt to Alcon Laboratories (UK) Limited on 9 March 2000. The marketing authorisation is valid for an unlimited period.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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