FDAnews
www.fdanews.com/articles/166192-eu-approves-alcons-simbrinza-eye-drops

EU Approves Alcon's Simbrinza Eye Drops

August 1, 2014

The European Commission has approved eye care product manufacturer Alcon’s Simbrinza combination eye drops to treat adults with glaucoma.

The drug, indicated for adult open-angle glaucoma or intraocular hypertension patients who have failed to respond adequately to other medications, will launch in the European Union in the third quarter of this year, the Novartis subsidiary said. The FDA approved Simbrinza (brinzolamide 10mg/mL and brimonidine tartrate 2mg/mL) last year.

Simbrinza addresses a significant unmet need as the only combination product that does not contain a beta blocker, a drug class commonly prescribed for glaucoma but contraindicated in many patients with certain cardiac or respiratory conditions, the company said. In addition, the drug provides a simplified administration schedule, allowing patients to use only one vial twice daily as opposed to multiple vials twice or more per day, said an Alcon spokeswoman.

This should help improve adherence, according to the European Glaucoma Society, which notes that up to 80 percent of patients diagnosed with glaucoma deviate from their prescribed treatments.

“Given that glaucoma is a disease typically of older people, they often forget to take the drugs, let alone take them effectively,” Scott Christensen, president and CEO of the Glaucoma Foundation in the U.S., said. “The more drops that you introduce, the greater the problem, because they have to remember to take each one.” — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.