Alcon receives positive CHMP opinion for Simbrinza®, a new fixed-dose combination medicine to treat patients with glaucoma
May 23, 2014
Simbrinza® reduced intraocular pressure in two Phase III studies by 23%-34%, 25%-37% respectively, providing strong efficacy, sustained control throughout the day
Only beta blocker-free, fixed-dose combination treatment in Europe for patients contraindicated for beta blockers due to certain respiratory or cardiac conditions,
If approved, will reduce patients' treatment burden, increase options to control high intraocular pressure, the only known modifiable risk factor for glaucoma
Over 60 million people worldwide live with glaucoma - Alcon offers one of the broadest portfolios to treat all stages of this progressive, eye disease,
Basel, May 23, 2014 - Alcon, the global leader in eye care and division of Novartis, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Simbrinza® eye drops suspension (brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL) to decrease elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension, for whom monotherapy provides insufficient IOP reduction.
Simbrinza® combines two medicines already approved for the treatment of elevated IOP into one multi-dose bottle, to be dosed with one drop into the affected eye(s) twice daily. If approved, this fixed-dose combination therapy will offer a simplified eye drop schedule and reduce the treatment burden for patients suffering from open-angle glaucoma or ocular hypertension.
"We are pleased by the positive CHMP 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", said Jeff George, Division Head, Alcon. "Alcon is committed to the research and development of medical and surgical solutions to treat this cause of irreversible blindness."
The CHMP opinion was based on two pivotal Phase III clinical trials, evaluating the safety and efficacy of Simbrinza® administered twice daily. Results showed that IOP reductions from baseline with Simbrinza® were 25%-37% in glaucoma patients, thus providing strong efficacy with sustained IOP control throughout the day. Simbrinza® is also the only fixed-dose combination therapy available to lower IOP that does not contain beta blockers. While beta blockers are often prescribed to effectively lower IOP, they are contraindicated in patients with certain respiratory or cardiac conditions.
"With effective treatments, we can slow down glaucoma progression. Elevated ocular pressure is the most important risk factor for glaucoma: so keeping eye pressure under control is the key to helping glaucoma patients preserve their sight," said Professor Stefano Gandolfi, MD, Head of Ophthalmologic Clinic, University of Parma, Italy, and one of the investigators. "Simbrinza®, if approved, will represent an effective and patient-focused option for treating a chronic sight-threatening disease, such as glaucoma."
The two, pivotal six-month Phase III studies evaluated the safety and efficacy of Simbrinza® administered twice daily, and enrolled a total of 1,450 patients with open-angle glaucoma or ocular hypertension who were insufficiently controlled on monotherapy or were already using multiple IOP-lowering medications. The primary endpoint for both studies was an assessment of mean diurnal IOP change from baseline at three months, with safety and supportive efficacy evaluated through six months. Both studies met their primary endpoints.
The first study compared Simbrinza® to brinzolamide 10 mg/mL eye drops suspension, administered twice daily, to brimonidine tartrate 2 mg/mL eye drops solution. Simbrinza® showed a statistically superior IOP-lowering effect compared to either brinzolamide or brimonidine at month 3, showing a 23%-34% reduction from baseline in IOP. The mean diurnal IOP reduction at month 3 was greater for patients treated with Simbrinza® (7.9 mmHg) vs. brinzolamide (6.5 mmHg) or brimonidine (6.4 mmHg) treatment groups. The mean baseline diurnal IOP for the Simbrinza, Brinzolamide, and Brimonidine treatment groups was 25.9, 25.9 and 26.0 mmHg, respectively.
The second study compared Simbrinza® to brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL, dosed concomitantly. The IOP-lowering effect of Simbrinza® was non-inferior to brinzolamide 10 mg/mL and brimonidine 2 mg/mL, administered concomitantly. Mean percent IOP reduction from baseline with Simbrinza® range from 25%-37%. The mean diurnal IOP reduction at month 3 was similar for patients in the Simbrinza® (8.5 mmHg) and Brinzolamide + Brimonidine (8.3 mmHg) treatment groups. The mean baseline diurnal IOP for Simbrinza and the Brinzolamide + Brimonidine treatment groups was 26.4 and 26.5 mmHg, respectively.
In clinical trials, the most frequently reported adverse drug reactions in patients treated with Simbrinza® were ocular hyperemia and ocular allergic type reactions. The safety profile of brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL eye drops suspension dosed twice daily (brinzolamide/brimonidine BD) was similar to that of the individual components and did not result in additional risk to patients relative to the known risks of the individual components.
About Glaucoma Glaucoma is the second cause of irreversible blindness after cataract and affects more than 60 million people worldwide.,, 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. There is no cure for glaucoma and vision lost cannot be restored. Medications can lower eye pressure, the only known modifiable risk factor for glaucoma, but must be taken life-long and regularly. The exact cause of glaucoma is unknown.
Disclaimer The foregoing release contains forward-looking statements that can be identified by words such as "positive CHMP opinion," "if approved," "will," "could," "positive opinion," "to be," "committed," "offer," or similar terms, or by express or implied discussions regarding potential marketing approvals for Simbrinza, or regarding potential future revenues from Simbrinza. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Simbrinza will be submitted or approved for sale in any additional markets, or at any particular time. Nor can there be any guarantee that Simbrinza will be commercially successful in the future. In particular, management's expectations regarding Simbrinza could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
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 10.5 billion in 2013. Headquartered in Fort Worth, Texas, U.S.A., Alcon has more than 25,000 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, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.