CHMP recommends Simbriza for Ocular Hypertension and Glaucoma - Alcon/Novartis

Alcon has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Simbrinza eye drops suspension (brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL) to decrease elevated intraocular pressure (IOP) in adult patients with open-angle Glaucoma or Ocular Hypertension, for whom monotherapy provides insufficient IOP reduction.

Simbrinza combines two medicines already approved for the treatment of elevated IOP into one multi-dose bottle, to be dosed with one drop into the affected eye(s) twice daily. If approved, this fixed-dose combination therapy will offer a simplified eye drop schedule and reduce the treatment burden for patients suffering from open-angle Glaucoma or Ocular Hypertension.

The CHMP opinion was based on two pivotal Phase III clinical trials, evaluating the safety and efficacy of Simbrinza administered twice daily. Results showed that IOP reductions from baseline with Simbrinza were 25%-37% in Glaucoma patients, thus providing strong efficacy with sustained IOP control throughout the day. Simbrinza is also the only fixed-dose combination therapy available to lower IOP that does not contain beta blockers. While beta blockers are often prescribed to effectively lower IOP, they are contraindicated in patients with certain respiratory or cardiac conditions.