Alcon receives positive NICE recommendation for Jetrea® to treat eligible patients with vitreomacular traction, including macular hole

One-time single eye injection of Jetrea® recognized as clinically and cost-effective treatment for eligible patients with vitreomacular traction, including macular hole

Jetrea® is the first and only approved pharmacological treatment in the UK for this sight-threatening condition
Vitreomacular traction with macular hole is an age-related eye condition that can cause loss of vision and impaired quality of life

Basel, October 23, 2013 – Alcon, the global leader in eye care, and second largest division of Novartis, is pleased that the National Institute for Health and Care Excellence (NICE) has recommended Jetrea® (ocriplasmin) as a clinically and cost-effective treatment option for eligible patients suffering from vitreomacular traction including when associated with macular hole. With this final NICE guidance, Jetrea® is now recommended for use within the National Health Service (NHS) in England and Wales as the first and only pharmacological treatment for this sight-threatening eye condition.

“We are very pleased by the NICE decision, as Jetrea® represents a breakthrough treatment option for patients in the UK, which is now recommended for use in the NHS,” said Stuart Raetzman, Area President Europe, Middle East and Africa, Alcon. “At Alcon, we aim to deliver positive patient outcomes through innovative medicines and medical devices. We work closely with doctors and health care providers to shape the future of eye care and offer solutions to address unmet patient needs.”

Vitreomacular traction and macular hole is an age-related, sight-threatening condition that may lead to visual distortion and central blindness.[1],[2],[3],[4],[5] Up to now, the clinical approach for treating vitreomacular traction has been ‘watchful waiting,’ meaning patients undergo a period of observation before they become eligible for eye surgery due to worsening of their condition. Due to the potential risks and complications, surgery is mostly reserved for patients who are heavily impacted by the symptoms of vitreomacular traction.

“People affected by vitreomacular traction can suffer vision changes that have a significant impact on their lives, making it difficult to do everyday activities like reading, watching TV and driving.” said Tim Jackson, Retinal Surgeon at King’s College Hospital. “Until now, eye doctors have only had surgical options to treat this disease, once it progressed to a severe stage. This new treatment is a welcome advance, meaning some patients can now avoid surgery, and others who might not be suitable for surgery can now be treated.”

Jetrea® was approved in March 2013 by the EU Commission for the treatment of vitreomacular traction, in adults, including when associated with macular hole of less than or equal to 400 microns.[6] In the UK, NICE recommended Jetrea® to treat patients suffering from vitreomacular traction, including macular hole of less than or equal to 400 microns when an epiretinal membrane is absent, or adults with vitreomacular traction and severe symptoms, when an epiretinal membrane and macular hole are both absent.[7]

It is delivered as a single, once-only injection into the eye, and studies showed that within 28 days, in approximately one out of four patients, Jetrea® successfully resolved vitreomacular adhesion. In addition, over 40% of patients treated with Jetrea® achieved closure of a macular hole by day 28.[8]

Alcon acquired the rights to commercialize Jetrea® outside the US from the Belgian biopharmaceutical company, ThromboGenics, which retains the rights to commercialize the drug in the US. In October 2012, Jetrea® was licensed in the US for the treatment of patients with symptomatic vitreomacular adhesion.

About vitreomacular traction, including macular hole
As people get older, the vitreous (jelly-like material inside the eye that helps maintain the round shape) detaches naturally from the retina (the light-sensitive layer of tissue located at the back of the eyeball). However, in some cases, the vitreous remains attached to areas of the retina, particularly at the macula (the area of the retina responsible for central vision needed for everyday tasks such as driving, reading and recognizing faces). This is known as vitreomacular adhesion. If left unresolved, these areas of vitreomacular adhesion can exert a ‘pulling force’ on the macula, a condition known as vitreomacular traction. Vitreomacular traction may eventually lead to the formation of a hole in the macula and is often responsible for progressive, sight-threatening symptoms and irreversible vision loss. Risk factors for vitreomacular traction and macular hole are undetermined, meaning anyone can be affected as they age.[9]

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as “positive recommendation,” “recommended,” “aim,” “shape the future,” “expect,” “potential,” or similar expressions, or by express or implied discussions regarding potential additional marketing approvals or recommendations for Jetrea or regarding potential future revenues from Jetrea. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Jetrea to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Jetrea will be approved for sale in any additional markets, or at any particular time. Nor can there be any guarantee that Jetrea will achieve any particular levels of reimbursement or revenue in the future. In particular, management’s expectations regarding Jetrea could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; government, industry and general public pricing pressures; competition in general; unexpected manufacturing issues; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; and the impact that the foregoing factors could have on the values attributed to the Novartis Group’s assets and liabilities as recorded in the Group’s consolidated balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. 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. Jetrea is a trademark of ThromboGenics NV, licensed to Alcon.

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 133,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

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References:

[1] Carpineto P, Di Antonio L, Aharrh-Gnama A, et al. Diagnosing and Treating Vitreomacular Adhesion. Retina 2011 69-73.
[2] Hikichi T, Yoshida A, Trempe C. Course of vitreomacular traction syndrome. Am J Ophthalmol. 1995;119(1):55-61.
[3] Bottós, Juliana, et al. Vitreomacular Traction Syndrome. Journal of Opthalmalic and Vision Research. 2012;7(2):148-161.
[4] Jaffe NS. Vitreous traction at the posterior pole of the fundus due to alterations in the vitreous posterior. Trans Am Acad Ophthalmol Otolaryngol. 1967;71(4):642-652.
[5] Johnson MW. Perifoveal vitreous detachment and its macular complications. Trans Am Ophthalmol Soc. 2005;103:537-567.
[6] Jetrea® Summary of Product Characteristics. ThromboGenics NV. Belgium; March 2013.
[7] NICE. Ocriplasmin for treating vitreomacular traction. NICE technology appraisal guidance 297. October 2013.
[8] Stalmans P, Benz MS, Gandorfer A, et al. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Engl J Med 2012;367:606-615.
[9] Steidl S, Hartnett ME. Clinical Pathways In Vitreoretinal Disease 2003;2:212.

SOURCE: Novartis