Alcon, the global leader in eye care and division of Novartis, 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.
"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. "Alcon is committed to the research and development of medical and surgical solutions to treat this cause of irreversible blindness."
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 Professor Stefano Gandolfi, MD, 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."
The two, pivotal six-month phase III studies evaluated 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.
The first study compared Simbrinza to brinzolamide 10 mg/mL eye drops suspension, administered twice daily, to brimonidine tartrate 2 mg/mL eye drops solution. Simbrinza showed a statistically superior IOP-lowering effect compared to either brinzolamide or brimonidine at month 3, showing a 23%-34% reduction from baseline in IOP. The mean diurnal IOP reduction at month 3 was greater for patients treated with Simbrinza (7.9 mmHg) vs. brinzolamide (6.5 mmHg) or brimonidine (6.4 mmHg) treatment groups. The mean baseline diurnal IOP for the Simbrinza, Brinzolamide, and Brimonidine treatment groups was 25.9, 25.9 and 26.0 mmHg, respectively.
The second study compared Simbrinza to brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL, dosed concomitantly. The IOP-lowering effect of Simbrinza was non-inferior to brinzolamide 10 mg/mL and brimonidine 2 mg/mL, administered concomitantly. Mean percent IOP reduction from baseline with Simbrinza range from 25%-37%. The mean diurnal IOP reduction at month 3 was similar for patients in the Simbrinza (8.5 mmHg) and Brinzolamide + Brimonidine (8.3 mmHg) treatment groups. The mean baseline diurnal IOP for Simbrinza and the Brinzolamide + Brimonidine treatment groups was 26.4 and 26.5 mmHg, respectively.
In clinical trials, the most frequently reported adverse drug reactions in patients treated with Simbrinza were ocular hyperemia and ocular allergic type reactions. The safety profile of brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL eye drops suspension dosed twice daily (brinzolamide/brimonidine BD) 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.
Alcon, the global leader in eye care, provides innovative products that enhance quality of life by helping people worldwide see better. The three Alcon businesses - Surgical, Pharmaceutical and Vision Care - offer the widest spectrum of eye care products in the world.