Alcon's Simbrinza(R) approved in the EU to treat patients living with glaucoma, a chronic sight-threatening eye disease

Mon Jul 28, 2014 1:16am EDT

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Novartis International AG / Alcon's Simbrinza® approved in the EU to treat patients living with glaucoma, a chronic sight-threatening eye disease . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

  • Simbrinza provides a convenient option to reduce treatment burden versus concomitant administration of single drugs
  • Simbrinza is the only beta blocker-free formulation combining two approved therapies, Brinzolamide 10mg/mL and Brimonidine 2mg/mL, in one single bottle
  • Largely underdiagnosed, glaucoma is a life-long, irreversible eye disease that can progressively lead to blindness if left untreated or not adequately managed
  • Clinical study results of Simbrinza to be presented at ESCRS congress and Glaucoma Day Programme on September 12, 2014, London, UK

Basel, July 28, 2014 - Alcon, the global leader in eye care and a division of Novartis, announced that Simbrinza® eye drops suspension (brinzolamide 10mg/mL and brimonidine tartrate 2mg/mL) has been approved by the European Commission to decrease elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension, for which monotherapy provides insufficient IOP reduction.[1]

Simbrinza, administered with one drop into the affected eye(s) twice daily, combines two well-established treatments for elevated IOP into one multi-dose bottle, offering a simplified schedule compared to brinzolamide and brimonidine administered separately. Simbrinza is also the only fixed-combination glaucoma treatment without a beta-blocker. Beta blockers are commonly prescribed to lower IOP, but are contraindicated for many glaucoma patients suffering from certain respiratory or cardiac conditions.[2]

"Simbrinza complements Alcon's glaucoma portfolio by addressing a significant unmet patient need. We are pleased to introduce the only fixed combination therapy without a beta-blocker to help more glaucoma patients manage their progressive eye condition," said Jeff George, Global Head of Alcon. "As the leader in eye care, Alcon will continue to invest in R&D to expand our broad portfolio of glaucoma treatment options and to further reduce the burden of this silent, sight-threatening disease."

Glaucoma is a group of chronic diseases with no cure and one of the leading causes of blindness worldwide. Open-angle glaucoma accounts for 74% of all cases worldwide.[3] This eye condition is asymptomatic, and less than 50% of those with glaucoma are aware of their disease before blindness.[4] Elevated IOP is the only known modifiable risk factor for glaucoma and can typically be controlled with daily administration of eye drops several times a day, or in the most severe cases, with surgery. In clinical studies, Simbrinza® showed strong efficacy to lower the IOP level from baseline by 23%-37%, while providing sustained IOP control throughout the day.[1]

"Based on the literature, up to 80%[5] of patients deviate from their treatment regimen, resulting in poor adherence and the increased risk of progressive vision loss", said Professor Barbara Cvenkel, MD, Head of Glaucoma Unit, Eye Hospital Ljubljana, Slovenia and member of the Executive Committee of the European Glaucoma Society (EGS). "When appropriate, the EGS recommends the use of combination therapies, such as Simbrinza®, which provides a less complicated administration routine by decreasing the number of eye drops to handle and reducing the treatment burden for patients affected by this eye disease."

The safety and efficacy of Simbrinza is based on two, pivotal six-month Phase III studies evaluating 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.[1]

In clinical studies, the most frequently reported adverse drug reactions in patients treated with Simbrinza were ocular hyperemia and ocular allergic type reactions.[1] The safety profile of brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL eye drops suspension dosed twice daily (brinzolamide/brimonidine) 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.

The results of these two studies will be presented at the 32nd Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) in London, UK, on September 13-17, 2014 and during the ESCRS Glaucoma Day Programme on September 12, 2014.

The launch of Simbrinza in the EU will start in the UK in the third quarter of 2014, followed by other European markets later in 2014 and in 2015. In the US, Simbrinza was approved by the US Food and Drug Administration (FDA) and has been available in the market since 2013.

About Glaucoma
Glaucoma is the second cause of blindness after cataract and affects more than 60 million people worldwide.[6],[3],[7] Glaucoma is a group of eye diseases that lead to progressive damage of the optic nerve[8] and can result in gradual, irreversible loss of vision and eventually blindness.[9] There is no cure for glaucoma and vision lost cannot be restored. Medications can lower eye pressure[10], the only known modifiable risk factor for glaucoma[11], but must be taken life-long and regularly.[8] The exact cause of glaucoma is unknown.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "can," "to be presented," "introduce," "will," "followed by," or similar terms, 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 any additional indications or labeling in any market, 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 company's ability to obtain or maintain proprietary intellectual property protection; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; 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, Ophthalmic Pharmaceuticals 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 sales of USD 10.5 billion in 2013. Headquartered in Fort Worth, Texas, USA, 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.

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References
[1] Alcon data on file, 2013.
[2] Houde M; Prescription of topical antiglaucoma agents for patients with contraindications to beta-blockers; Can J Ophthalmol. 2003 Oct;38(6):469-75.
[3] H A Quigley and A T Broman; The number of people with glaucoma worldwide in 2010 and 2020; Br J Ophthalmol. Mar 2006; 90(3): 262-267.
[4] Quigley HA; Number of people with glaucoma worldwide; Br J Ophthalmol. 1996 May;80(5):389-93.
[5] Olthoff CM1, Schouten JS, van de Borne BW, Webers CA; Noncompliance with ocular hypotensive treatment in patients with glaucoma or ocular hypertension an evidence-based review; Ophthalmology. 2005 Jun;112(6):953-61.
[6] European Glaucoma Society (EGS), Terminology and Guidance for Glaucoma, 3rd edition, 2008.
[7] Lighthouse International. Prevalence of Vision Impairment. http://www.lighthouse.org/research/statistics-on-vision-impairment/prevalence-of-vision-impairment/
[8] National Eye Institute. Facts About Glaucoma, Glaucoma Symptoms. http://www.nei.nih.gov/health/glaucoma/glaucoma_facts.asp#a
[9] Glaucoma Research Foundation. Understand Your Glaucoma Diagnosis. http://www.glaucoma.org/treatment/understand-your-glaucoma-diagnosis.php
[10] Coleman, A., Kodjebacheva, G. Open Ophthalmol J. 2009; 3: 38-42. Risk Factors for Glaucoma Needing More Attention. 2009 Sept. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2759104/
[11] International Agency for the Prevention of Blindness http://www.iapb.org/vision-2020/what-is-avoidable-blindness/glaucoma


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