EMA/CHMP backs Alcon’s Simbrinza for glaucoma

Swiss drug major Novartis’ (NOVN: VX) eye care division Alcon says that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Simbrinza eye drops suspension (brinzolamide 10mg/mL and brimonidine tartrate 2mg/mL) to decrease elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension, for whom monotherapy provides insufficient IOP reduction.

The combination product was recently approved by the US Food and Drug Administration for this same indication (The Pharma Letter April 22). Simbrinza is the only beta blocker-free, fixed-dose combination treatment in Europe for patients contraindicated for beta blockers due to certain respiratory or cardiac conditions

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.

Simple dosing will help patients

"We are pleased by the positive CHMP opinion for Simbrinza. Glaucoma is a progressive eye disease that must be treated every day over the course of a patient's life. By combining two therapies in one, Simbrinza will help patients to effectively manage high eye pressure, with a simple dosing regimen," said Jeff George, division head, Alcon."

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.

"With effective treatments, we can slow down glaucoma progression. Elevated ocular pressure is the most important risk factor for glaucoma: so keeping eye pressure under control is the key to helping glaucoma patients preserve their sight," said Stefano Gandolfi, a professor and head of Ophthalmologic Clinic, University of Parma, Italy, and one of the investigators. "Simbrinza, if approved, will represent an effective and patient-focused option for treating a chronic sight-threatening disease, such as glaucoma," he added.