Alcon’s Simbrinza® approved in the EU to treat patients living with glaucoma, a chronic sight-threatening eye disease

Alcon, the global leader in eye care and a division of Novartis, announced that Simbrinza® eye drops suspension (brinzolamide 10mg/mL and brimonidine tartrate 2mg/mL) has been approved by the European Commission to decrease elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension, for which monotherapy provides insufficient IOP reduction.¹

Simbrinza, administered with one drop into the affected eye(s) twice daily, combines two well-established treatments for elevated IOP into one multi-dose bottle, offering a simplified schedule compared to brinzolamide and brimonidine administered separately. Simbrinza is also the only fixed-combination glaucoma treatment without a beta-blocker. Beta blockers are commonly prescribed to lower IOP, but are contraindicated for many glaucoma patients suffering from certain respiratory or cardiac conditions.²

“Simbrinza complements Alcon’s glaucoma portfolio by addressing a significant unmet patient need. We are pleased to introduce the only fixed combination therapy without a beta-blocker to help more glaucoma patients manage their progressive eye condition,” said Jeff George, Global Head of Alcon. “As the leader in eye care, Alcon will continue to invest in R&D to expand our broad portfolio of glaucoma treatment options and to further reduce the burden of this silent, sight-threatening disease.”

Glaucoma is a group of chronic diseases with no cure and one of the leading causes of blindness worldwide. Open-angle glaucoma accounts for 74% of all cases worldwide.³ This eye condition is asymptomatic, and less than 50% of those with glaucoma are aware of their disease before blindness.⁴ Elevated IOP is the only known modifiable risk factor for glaucoma and can typically be controlled with daily administration of eye drops several times a day, or in the most severe cases, with surgery. In clinical studies, Simbrinza® showed strong efficacy to lower the IOP level from baseline by 23%-37%, while providing sustained IOP control throughout the day.¹

“Based on the literature, up to 80%⁵ of patients deviate from their treatment regimen, resulting in poor adherence and the increased risk of progressive vision loss”, said Professor Barbara Cvenkel, MD, Head of Glaucoma Unit, Eye Hospital Ljubljana, Slovenia and member of the Executive Committee of the European Glaucoma Society (EGS). “When appropriate, the EGS recommends the use of combination therapies, such as Simbrinza®, which provides a less complicated administration routine by decreasing the number of eye drops to handle and reducing the treatment burden for patients affected by this eye disease.”

The safety and efficacy of Simbrinza is based on two, pivotal six-month Phase III studies evaluating the safety and efficacy of Simbrinza administered twice daily, and enrolled a total of 1,450 patients with open-angle glaucoma or ocular hypertension who were insufficiently controlled on monotherapy or were already using multiple IOP-lowering medications. The primary endpoint for both studies was an assessment of mean diurnal IOP change from baseline at three months, with safety and supportive efficacy evaluated through six months. Both studies met their primary endpoints.¹

In clinical studies, the most frequently reported adverse drug reactions in patients treated with Simbrinza were ocular hyperemia and ocular allergic type reactions.¹ The safety profile of brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL eye drops suspension dosed twice daily (brinzolamide/brimonidine) was similar to that of the individual components and did not result in additional risk to patients relative to the known risks of the individual components.

The results of these two studies will be presented at the 32nd Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) in London, UK, on September 13-17, 2014 and during the ESCRS Glaucoma Day Programme on September 12, 2014.

The launch of Simbrinza in the EU will start in the UK in the third quarter of 2014, followed by other European markets later in 2014 and in 2015. In the US, Simbrinza was approved by the US Food and Drug Administration (FDA) and has been available in the market since 2013.

References

1. Alcon data on file, 2013.
2. Houde M; Prescription of topical antiglaucoma agents for patients with contraindications to beta-blockers; Can J Ophthalmol. 2003 Oct;38(6):469-75.
3. H A Quigley and A T Broman; The number of people with glaucoma worldwide in 2010 and 2020; Br J Ophthalmol. Mar 2006; 90(3): 262-267.
4. Quigley HA; Number of people with glaucoma worldwide; Br J Ophthalmol. 1996 May;80(5):389-93.
5. Olthoff CM1, Schouten JS, van de Borne BW, Webers CA; Noncompliance with ocular hypotensive treatment in patients with glaucoma or ocular hypertension an evidence-based review; Ophthalmology. 2005 Jun;112(6):953-61.