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FDA approves Alcon eye drug Simbrinza

Fixed-combination licensed to treat glaucoma patients in the US

Eyes examNovartis subsidiary Alcon has been given a boost after US regulators approved its fixed-combination eye treatment Simbrinza Suspension.

It is indicated for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. 

This pressure is the only modifiable risk factor for glaucoma - a group of eye diseases that lead to progressive damage of the optic nerve, ending in blindness if not treated - and Simbrinza has been shown to decrease it by 21-35 per cent.

The treatment combines a carbonic anhydrase inhibitor (brinzolamide 1.0 per cent) and an alpha 2 adrenergic receptor agonist (brimonidine tartrate 0.2 per cent) into one multi-dose bottle, and patients administer one drop to the affected eye three times a day.

In two pivotal phase III trials of around 1,300 patients, the combination was shown to be statistically superior to three times a day dosing of each component on their own when it came to mean IOP after three months.

In both studies, Simbrinza achieved a 5mm Hg to 9mm Hg reduction from baseline to month three, given that patients' mean IOP at baseline was 22mm Hg to 36mm Hg. 

Glaucoma is a major problem: it is the world's second-leading cause of preventable blindness and there are more than 67 million sufferers.

Alcon believes that Simbrinza's reduction of patients' medication burden and the fact that it can offer sustained daily control of pressure in the eye are key points in its favour.

The most frequently reported adverse reactions in the two trials were blurred vision, eye irritation, dysgeusia, dry mouth and eye allergy, with treatment discontinuation mainly due to these factors reported in 11% of Simbrinza patients. No significant cardiovascular or pulmonary events were found in either study.

While the exact cause of glaucoma is unknown and it is possible for patients with a normal range of IOP to develop the condition, control of a major risk factor is clearly significant.

Yet diagnosis itself is a problem since about 50 per cent of all glaucoma cases remain undiagnosed until considerable, irreversible damage has already occurred, a state of affairs which has led to its nickname 'the silent thief of sight'.

“Given its excellent efficacy, established safety profile, and the fact that it is the only available, fixed-dose combination without a beta-blocker approved in the US, Simbrinza has the potential to re-shape the treatment paradigm for glaucoma,” said Robert Warner, Alcon's area president, US and Canada.

23rd April 2013

From: Sales



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