European authorities issue positive opinion for Simbrinza

Alcon announced last week that it received a positive opinion from the Committee for Medicinal Products for Human Use for Simbrinza.

The twice-daily fixed-dose combination therapy comprises brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL and does not contain beta-blockers, according to a company press release. The product is designed to reduce IOP in patients with glaucoma.

“We are pleased by the positive CHMP [Committee for Medicinal Products for Human Use] 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,” Jeff George, division head of Alcon, said in the release. “Alcon is committed to the research and development of medical and surgical solutions to treat this cause of irreversible blindness.”

The CHMP issued the positive opinion based results from two phase 3 clinical trials that assessed the safety and efficacy of twice-daily administration of Simbrinza.

The trials, which evaluated 1,450 participants, showed a 25% to 37% reduction of IOP from baseline in patients who used Simbrinza, according to the release.

“With effective treatments, we can slow down glaucoma progression,” Stefano Gandolfi, MD, one of the study authors, said in the release. “Simbrinza, if approved, will represent an effective and patient-focused option for treating a chronic sight-threatening disease, such as glaucoma.”

Simbrinza was approved for use in the U.S. in 2013.