Alcon, the global leader in eye care and a division of Novartis, announces US FDA approval for Simbrinza(TM) Suspension, indicated for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension.
Elevated IOP is the only modifiable risk factor for glaucoma.
Glaucoma is a group of eye diseases that lead to progressive damage of the optic nerve and can result in gradual, irreversible loss of vision, and eventually blindness, if left untreated. Glaucoma affects more than 2.2 million Americans and is the second-leading cause of preventable blindness worldwide.
Simbrinza is a fixed-dose combination medication that offers a wide range of treatment possibilities due to its strong efficacy and ability to decrease elevated IOP by 21-35%.
In addition, it is the only available, fixed-dose combination therapy for glaucoma in the US without a beta blocker.
"Alcon is the global leader in providing both pharmaceutical and surgical options for patients living with glaucoma," said Robert Warner, Area President, US and Canada for Alcon.
"The introduction of Simbrinza further expands our ability to provide effective treatments for patients with elevated IOP. Given its excellent efficacy, established safety profile, and the fact that it is the only available, fixed-dose combination without a beta blocker approved in the US, Simbrinza has the potential to re-shape the treatment paradigm for glaucoma."
The new ophthalmic suspension is a fixed-dose combination of a carbonic anhydrase inhibitor (Brinzolamide 1.0%) and an alpha 2 adrenergic receptor agonist (Brimonidine Tartrate 0.2%). It combines the two drugs into one multi-dose bottle, helping to reduce the medication burden for glaucoma patients. Patients are to administer one drop of Simbrinza into the affected eye(s), three times per day.
"Simbrinza represents an important new option for treating glaucoma patients with elevated IOP," said Gregory Katz, MD, Glaucoma Service, St. Joseph Mercy Medical Center, Ann Arbor, Michigan.
"Glaucoma must be treated over the course of one's life, and elevated eye pressure must be managed every day. It's exciting to now have a product available that combines two effective compounds into one multi-dose combination, offering sustained control."
The FDA approval of Simbrinza is based on data from two pivotal Phase III clinical trials with approximately 1,300 patients. The studies evaluated the safety and efficacy of a fixed-dose combination of Brinzolamide 1.0% and Brimonidine 0.2%, administered three times daily, compared to separate three-times-per-day dosing of one or the other component.
Both studies met their primary endpoint and demonstrated that Simbrinza is statistically superior compared to either component regarding mean IOP at Month 3 for all time points. In both studies, Simbrinza achieved a 5 mm Hg to 9 mm Hg reduction from baseline to Month 3. Patients' mean IOP at baseline was 22 mm Hg to 36 mm Hg.
In the two three-month clinical trials, the most frequently reported adverse reactions in patients treated with Simbrinza (occurring in approximately 3-5% of patients in descending order of incidence) were blurred vision, eye irritation, dysgeusia (bad taste), dry mouth and eye allergy.
Treatment discontinuation mainly due to adverse reaction was reported in 11% of Simbrinza patients. The safety profile of the combination agent (Simbrinza) is comparable to each of the individual components.
Additionally, there were no significant cardiovascular or pulmonary events found with Simbrinza in either clinical study conducted.