Alcon's Simbrinza Receives European Approval For Glaucoma
Novartis Group’s second largest division Alcon announced that its eye drops suspension Simbrinza has been approved by the European Commission for EU patients with glaucoma.
The EC approved Simbrinza for the reduction of increased intraocular pressure (IOP) in adults with open-angle glaucoma or ocular hypertension that has not been sufficiently treated with monotherapy. The fixed-combination drug combines two treatments (brinzolamide and brimonidine) without beta-blocker for high IOP. Beta blockers can reduce IOP but are contraindicated for some patients with respiratory or cardiac conditions.
Jeff George, Global Head of Alcon, said, “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.” George said that the company will sustain its investment in R&D for its glaucoma portfolio.
The approval for Simbrinza was supported by positive results from two pivotal Phase III studies of Simbrinza in 1,450 patients with open-angle glaucoma or ocular hypertension. Results show that the drug significantly lowered the IOP level from baseline and maintained IOP control throughout the day.
With 80 percent of patients adhering poorly to their treatment regimens, the risk of progressive loss of remaining vision climbs up. “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,” said Professor Barbara Cvenkel, Head of Glaucoma Unit at the Eye Hospital Ljubljana, Slovenia and member of the Executive Committee of the European Glaucoma Society (EGS).
The company said it will present Simbrinza’s clinical study results at the European Society of Cataract and Refractive Surgeons (ESCRS) 32nd congress and Glaucoma Day Program to be held in London, UK this September.
Last month Alcon unveiled its latest Optix Colors under its Vision Care business, one of its three main operations along with Surgical and Ophthalmic Pharmaceuticals. The company grossed $10.5 billion in 2013 alone in pro-forma sales.