Simbrinza offers a wide range of treatment possibilities due to its strong efficacy, providing sustained control and a 21%-35% reduction in intraocular pressure[1],[2],[3]
Combines Brinzolamide 1.0% and Brimonidine Tartrate 0.2% into one multi-dose bottle[1],[4]
Alcon provides a broad spectrum of pharmaceutical and surgical glaucoma treatment solutions to address patient needs at all stages of the disease
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.[4] 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[5] and can result in gradual, irreversible loss of vision, and eventually blindness, if left untreated.[6] Glaucoma affects more than 2.2 million Americans[7] and is the second-leading cause of preventable blindness worldwide.[8]
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%.[1],[2],[3] In addition, it is the only available, fixed-dose combination therapy for glaucoma in the US without a beta blocker.[1],[2]
“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%).[1],[4] It combines the two drugs into one multi-dose bottle, helping to reduce the medication burden for glaucoma patients.[9] 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.[1],[2] 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.[1],[2] 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. [1],[2] In both studies, Simbrinza achieved a 5mm Hg to 9mm Hg reduction from baseline to Month 3. Patients’ mean IOP at baseline was 22mm Hg to 36mm Hg. [1],[2],[3]
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.[4] The safety profile of the combination agent (Simbrinza) is comparable to each of the individual components. [1],[2] Additionally, there were no significant cardiovascular or pulmonary events found with Simbrinza in either clinical study conducted. [1],[3]
About Glaucoma
More than 67 million people worldwide have glaucoma, which is the second-leading cause of preventable blindness[8] and a disease that many know little about.[10] Glaucoma is a group of eye diseases that lead to progressive damage of the optic nerve.[5] Because the optic nerve transmits information from the eye to the brain,[11] glaucoma can result in a gradual, irreversible loss of vision and eventually blindness, if left untreated.[6] Elevated eye pressure is often present and is considered a risk factor for glaucoma.[11] However, in rare cases, even patients with a normal range of IOP can develop the disease.[6] The exact cause of glaucoma is unknown.
About Alcon
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. Alcon is the second largest division of the Novartis Group with pro-forma sales of USD 10.2 billion in 2012. Headquartered in Fort Worth, Texas, U.S.A., Alcon has more than 24,000 employees worldwide, operations in 75 countries and products available in 180 markets. For more information, visit www.alcon.com.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 128,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.
References
Katz G, DuBiner H, Samples J, et al. Three-month randomized trial of fixed-combination Brinzolamide 1%/Brimonidine 0.2% versus Brinzolamide 1% versus Brimonidine 0.2% in patients with open-angle glaucoma or ocular hypertension. Glaucoma.
Nguyen QH, McMenemy MG, Realini T. Phase 3 randomized 3-month trial with an ongoing 3-month safety extension of fixed-combination Brinzolamide 1%/Brimonidine 0.2%. J Ocul Pharmacol Ther.
Data on file, 2013
Simbrinza Suspension Package Insert
American Optometric Association. Glaucoma http://www.aoa.org/Glaucoma.xml
National Eye Institute. Facts about Glaucoma http://www.nei.nih.gov/health/glaucoma/glaucoma_facts.asp
Glaucoma Research Foundation, Glaucoma Facts and Stats http://www.glaucoma.org/glaucoma/glaucoma-facts-and-stats.php
Lighthouse International, Prevalence of Vision Impairment http://www.lighthouse.org/research/statistics-on-vision-impairment/prevalence-of-vision-impairment/
Curr Hypertens Rep. 2007 Jun;9(3):184-9 Compliance and Fixed-dose Combination Therapy http://www.ncbi.nlm.nih.gov/pubmed/17519122
Burr JM, Mowatt G, Hernández R, Siddiqui MA, Cook J, Lourenco T, et al. The clinical effectiveness and cost-effectiveness of screening for open angle glaucoma: a systematic review and economic evaluation. Health Technology
Glaucoma Research Foundation. What is Glaucoma, How Glaucoma Affects the Optic Nerve http://www.glaucoma.org/glaucoma/the-optic-nerve-questions-and-answers-from-dr-bradley-schuster.php