European Commission Approves Novartis’ Simbrinza

Novartis’ Ophthalmology Division, Alcon, Receives European Commission Approval for SimbrinzaThe European Commission have announced that they have granted regulatory approval to Alcon’s (Novartis’ ophthalmology division) Simbrinza, the only fixed-combination therapy for patients with glaucoma that doesn’t involve a beta-blocker.

The European regulators have approved Simbrinza (brinzolamide / brimonidine tartrate) to decrease elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension, where monotherapy provides insufficient IOP reduction.

It combines two well-established treatments for elevated intraocular pressure into one multi-dose bottle, “offering a simplified schedule compared to brinzolamide and brimonidine administered separately,” claim Novartis.  The combined treatment hopes to help tackle current poor adherence rates to therapy.

Clinical trials of Simbrinza demonstrated strong efficacy to reducing the IOP level from baseline by 23%-37%, while providing sustained IOP control throughout the day.

Professor Barbara Cvenkel, MD, Head of Glaucoma Unit, Eye Hospital Ljubljana, Slovenia claimed that up to 80% of patients stray from their planned treatment regimen, which can increase the risk of progressive vision loss.

As Simbrinza doesn’t contain a beta-blocker, it also helps address a significant unmet need for glaucoma patients who also suffer from certain respiratory or cardiac conditions.

Glaucoma is one of the leading causes of blindness, and open-angle glaucoma accounts for 74% of all cases worldwide. Less than 50% of patients are aware of their disease before blindness, and elevated IOP is the only known modifiable risk factor.

Simbrinza has been given regulatory approved by the US FDA last year.  The company is planning on launching the treatment in the UK later in the third quarter of this year, followed by launching Simbrinza in other European markets later in 2014 and 2015.

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