Alcon Receives Positive CHMP Opinion For Glaucoma Drug Simbrinza

Novartis division in eye care Alcon reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Simbrinza eye drops suspension in patients with glaucoma or ocular hypertension.

The CHMP gave a favorable opinion of Simbrinza (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 proves insufficient for IOP reduction. If approved, the drug will make treatment less of a burden and give patients another way to control high IOP — currently the only known risk factor for glaucoma that can be altered.

Jeff George, Division Head of Alcon, said, “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.” Simbrinza combines two FDA-approved drugs for high IOP in one multi-dose bottle.

The positive Committee opinion was supported by two pivotal Phase III clinical trials for Simbrinza. Data showed that Simbrinza achieved 25 to 37 percent IOP reductions from baseline in patients with glaucoma. The trials involved a total of 1,450 patients with open-angle glaucoma or ocular hypertension who did not see results from monotherapy or who have already been prescribed multiple IOP-lowering medications.

Glaucoma is a leading cause of irreversible blindness after cataract, afflicting over 60 million people around the world. As of present, no cure for glaucoma exists and lost vision cannot be restored. Drugs that lower eye pressure in glaucoma must be taken for life on a regular schedule.

“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, Head of Ophthalmologic Clinic, University of Parma, Italy, and one of the investigators. Professor Gandolfi said that Simbrinza offers a strong, patient-centered option for the treatment of glaucoma.