Fort Worth based Alcon, a division of Novartis, has announced US FDA approval for Simbrinza Suspension, a new beta blocker-free, fixed-combination therapy for glaucoma patients, indicated for the reduction of elevated IOP in patients with primary open-angle glaucoma or ocular hypertension.
Alcon, which provides a broad spectrum of pharmaceutical and surgical glaucoma treatment solutions to address patient needs at all stages of the disease, says Simbrinza offers a wide range of treatment possibilities due to its strong efficacy, providing sustained control and a 21%-35% reduction in intraocular pressure. This 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%), combining, the two drugs into one multi-dose bottle, thus helping reduce the medication burden for glaucoma patients. Patients are to administer one drop of Simbrinza into the affected eye(s), three times per day.
“Alcon is the global leader in providing both pharmaceutical and surgical options for patients living with glaucoma,” says 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.”
“Simbrinza represents an important new option for treating glaucoma patients with elevated IOP,” says 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.”
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 5mm Hg to 9mm Hg reduction from baseline to Month 3. Patients’ mean IOP at baseline was 22mm Hg to 36mm 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.
Through the 2011 merger of Novartis and Alcon, uniting the strengths of Alcon, CIBA VISION and Novartis Ophthalmics into one eye care business, the three Alcon businesses franchises – Surgical, Pharmaceutical and Vision Care – are claimed to offer the widest spectrum of eye care products in the world. Founded in 1945, Alcon is now the the Novartis Group’s second-largest division, with pro-forma sales of USD 10.2 billion in 2012. Headquartered in Fort Worth, Texas, Alcon has more than 24,000 employees worldwide, operations in 75 countries and products available in 180 markets.
The company’s Surgical portfolio includes technologies and devices for cataract, retinal and glaucoma surgery, as well as Lasik surgery for the treatment of refractive errors, like presbyopia and astigmatism. The Pharmaceutical portfolio includes advanced treatments for glaucoma, eye infections and inflammation, ocular allergies, dry eye, and ear infections. Through the integration of CIBA VISION, the Alcon Vision Care franchise is now one of the largest manufacturers of contact lenses and lens care products.
Alcon also has more than 2,000 people around the globe dedicated to R&D working to advance future innovations to treat unmet patient needs. The company is currently developing products to treat cataracts, glaucoma, age-related macular degeneration, retinal diseases, dry eye, infection, inflammation, ocular allergies, refractive errors and other ocular health issues.
Over the next five years, Alcon plans to invest approximately USD 5 billion to discover and develop new and innovative treatments for vision conditions and eye diseases. As part of Novartis, Alcon will also leverage the capabilities and resources of the Novartis Institutes for BioMedical Research to further accelerate product innovations for the eye.
In terms of corporate social responsibility, Alcon affirms that everyone should have access to quality eye care, regardless of their economic circumstances, and recognizes that barriers to good eye health exist in both developed and emerging markets. Through our corporate giving, partnerships, medical missions and volunteer efforts Alcon invests in initiatives that give access to eye care to people throughout the developing world, in programs that focus on research, and in the education of future eye care professionals – while also working to support local communities. The Alcon foundation annually donates over USD 60 million in both cash and in-kind products to charitable activities, and supports more than 800 medical missions in over 90 countries.
Glaucoma: Further Perspectives
Glaucoma is an insidious-onset eye disease that afflicts more than 67 million people worldwide, some 2.2 million in the U.S. Despite being the second-leading cause of preventable blindness, glaucoma has a relatively low public profile. Actually a group of diseases, the onset of glaucoma, known as the “silent thief of sight” without noticeable warning symptoms and as much as 40 percent of your vision can be lost before you even begin to notice, so regular check-ups with an eye care professional are critical.
Glaucoma causes gradual, progressive damage to more than 30 million people who are slowly losing their sight without notice. Currently, there are 4.5 million people around the world who are blind from the disease due to progressive damage to,the optic nerve that if left untreated can result in irreversible loss of peripheral vision (“tunnel vision”) and eventually blindness.
This writer’s late father was a glaucoma sufferer, and diminished peripheral vision was a likely factor contributing to his death in a train/car collision. The standard measurable and only modifiable risk factor for glaucoma development is elevated infra ocular pressure (IOP) — high pressure inside the eye that can be easily and quickly tested for in an eye examination using a puff of air by an opthalmologist or optometrist — especially advisable if one has a family history of glaucoma. Regular eye exams are essential, since early stage glaucoma tends to be asymptomatic, and patients can lose up to 40% of their vision before realizing they have glaucoma.
The two main types of glaucoma are primary, or open-angle glaucoma, and acute, or angle-closure glaucoma. Open-angle glaucoma accounts for nearly 90 percent of all cases of glaucoma and is often asymptomatic, so symptoms often remain undetected until an advanced stage. It occurs when drainage from the anterior chamber of the eye occurs too slowly, causing IOP to increase. Angle-closure glaucoma, on the other hand, is less common, but can cause a sudden buildup of pressure in the eye,20 requiring immediate medical attention. Signs and symptoms of angle-closure glaucoma may include headaches, eye pain, nausea, rainbows around lights at night and blurred vision.
Besides elevated IOP, several other factors can increase risk of developing glaucoma, including a family history of glaucoma, anyone over age 60, African-Americans over age 40, people of Asian descent (risk for angle-closure glaucoma, specifically)! diabetes, high blood pressure and heart disease, physical eye injuries, and use of steroids for a long period of time.
So far, so good with me, and I’m now older than my dad was when he developed the disease, although in rare instances, even patients with a normal range of IOP can develop the disease. The exact cause of glaucoma is unknown, and once established it is not curable in the sense that vision lost cannot be restored. However, remaining vision may be preserved through treatment. Glaucoma can be treated with eye drops, oral medications, laser surgery, traditional surgery, or a combination of these methods.