What is Azopt?
Azopt is a white suspension to be used as an eye drop, containing the active substance brinzolamide (10 mg / ml).
What is AZOPT used for?
AZOPT is indicated to reduce intraocular pressure (ie the pressure inside the eye) in patients with ocular hypertension (increased pressure inside the eye) or open-angle glaucoma (an illness in which there is an increase of eye pressure due to the fact that the aqueous humor cannot flow out of the eye). It is used as an adjunctive therapy to beta-blockers or prostaglandin analogues (other drugs used in the treatment of these conditions) or as monotherapy (alone) in patients who cannot take beta-blockers or if these drugs have proved ineffective. .
The medicine can only be obtained with a prescription.
How is Azopt used?
The dosage of Azopt is one drop in the eye or in the affected eyes twice a day. Some patients may have a better response by giving a drop three times a day. It is necessary to shake the suspension before use.
The use of Azopt is not recommended in patients with liver disease, given the lack of information on the safety and efficacy of the medicine in this category of patients. It must also not be given to patients with severe kidney failure. No adequate experience on the pediatric use of Azopt was collected.
How does Azopt work?
The increase in intraocular pressure causes damage to the retina (the light-sensitive membrane located at the back of the eye) and to the optic nerve (nerve used to send signals from the eye to the brain), causing severe vision loss. and even blindness. By lowering the pressure, Azopt reduces the risk of injury.
The active substance in Azopt, brinzolamide, is a carbonic anhydrase inhibitor, which works by blocking the enzyme responsible for producing bicarbonate ions in the body. Bicarbonate is necessary for the production of aqueous humor (the transparent liquid present in the eye).
By blocking the production of bicarbonate in the eye, Azopt slows the production of aqueous humor, reducing the pressure inside the eye.
What studies have been carried out on Azopt?
The effectiveness of Azopt was examined in seven main studies involving a total of 2 173 patients with open-angle glaucoma or ocular hypertension. In three studies, Azopt given as monotherapy two or three times a day was compared to dorzolamide (another carbonic anhydrase inhibitor) and to timolol (a beta-blocker). Two of these studies lasted three months, while the third, in which Azopt was compared to timolol, lasted 18 months. In two studies the efficacy of Azopt, dorzolamide or placebo (a dummy treatment) was compared as an add-on therapy to timolol over three months. Finally, two studies compared the effectiveness of Azopt taken twice a day with that of timolol, when used as an adjunctive therapy to travoprost (a prostaglandin analogue), for over 12 weeks out of a total of 390 patients.
In all studies, the main measure of effectiveness was the change in intraocular pressure measured in "millimeters of mercury" (mmHg).
What benefit has Azopt shown during the studies?
In monotherapy, Azopt was less effective than timolol. Azopt caused a reduction in intraocular pressure between 2.7 and 5.7 mmHg compared to a reduction of between 5.2 and 6.0 mmHg found with timolol. In a patient with glaucoma, the eye pressure is generally higher than 21 mmHg.
Azopt was found to be as effective as dorzolamide when used as monotherapy or as an add-on therapy to timolol, reporting pressure reductions ranging from 3.4 to 5.7 mmHg. The reductions shown with dorzolamide ranged from 4.3 to 4.9 mmHg. Azopt was also more effective than placebo as an add-on to timolol.
When used as adjunctive therapy to travoprost, Azopt showed the same efficacy as timolol in reducing eye pressure. In both studies, the addition of Azopt or timolol resulted in a further decrease in eye pressure of about 3.5 mmHg after 12 weeks.
In general, Azopt showed similar efficacy regardless of the dosage regimen (intake two or three times a day). However, the results of the studies showed that a greater reduction in intraocular pressure can be observed with the administration of 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, dryness ocular, ocular excretion, ocular itching, feeling of having a foreign body in the eye, ocular hyperemia (red eyes) 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, to any of the other ingredients or to sulfonamides (such as some antibiotics). Furthermore, it must not be used in patients suffering from severe renal insufficiency or hyperchloraemic acidosis (excess acid in the blood caused by the excessive presence of chloride). Azopt contains benzalkonium chloride, which can make soft contact lenses opaque; therefore, people who wear soft contact lenses should pay particular attention.
Why has Azopt been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Azopt's benefits are greater than its risks for reducing high intraocular pressure in cases of ocular hypertension or open-angle glaucoma and therefore recommended that authorization be given to the marketing of the product.
More information on Azopt
On 9 March 2000, the European Commission issued a marketing authorization valid for the whole of the European Union to Alcon Laboratories (UK) Limited. The marketing authorization was renewed on 9 March 2005.
The full EPAR for Azopt can be found here.
Last update of this summary: 06-2008.
