Novartis’ ophthalmic unit Alcon has won approval for its fast-growing glaucoma treatment Simbrinza in Europe, a little over a year after it was launched in the US.
Simbrinza (brinzolamide and brimonidine) is the only fixed-combination glaucoma treatment available that does not include a beta-blocker, a drug class that is contraindicated in glaucoma patients who also suffer from certain respiratory or cardiac conditions, according to Alcon.
It provides a solution to a “significant unmet patient need” in glaucoma, according to Alcon’s global head Jeff George.
Specifically, Simbrinza has been approved by the European Commission to decrease elevated intraocular pressure (IOP) in adults with open-angle glaucoma or ocular hypertension for which monotherapy provides insufficient IOP reduction. Alcon’s marketing application was given a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in May.
IOP is the only modifiable risk factor for glaucoma – a group of eye diseases characterised by progressive damage to the optic nerve that can lead to blindness if not treated – and in trials Simbrinza was able to decrease it by 23-37 per cent.
Simbrinza was a key factor in driving Alcon’s ophthalmic pharmaceutical sales in the first half of the year at a time when the unit is facing competition to its prostaglandin-based glaucoma therapy Travatan (travoprost) from generic latanoprost products. Overall, the firm’s glaucoma sales rose 5 per cent in the first half of this year to $629m.
Simbrinza’s EU launch will start in the UK later this quarter, followed by other European markets in the remainder of 2014 and in 2015. The drug was approved by the FDA in April last year.
There are around 67 million people living with glaucoma worldwide and sales of pharmaceutical products to treat the condition are expected to grow from around $4bn in 2013 to $5bn by 2018, according to figures from Clarus Ventures. About 50 per cent of all glaucoma cases are undiagnosed until irreversible damage to eyesight has already occurred.
The pipeline of new treatments for glaucoma is fairly well stocked meanwhile, with a number of companies exploring the role of Rho kinase inhibitor (ROCKi) drugs in the disease, including: Aerie Pharmaceuticals (AR-13324 and PG324; phase III); Kowa (K-115; phase III); Amakem Therapeutics (AMA0076; phase II) and Altheos (ATS907; phase II).