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Media releases

March 18, 2013 07:15 CET

Alcon announces EU approval of Jetrea®, first and only eye drug to treat sight-threatening vitreomacular traction and macular hole

  • Jetrea represents a breakthrough for patients with vitreomacular traction (VMT), a sight-threatening progressive condition, if left untreated[1]

  • One-time intravitreal injection of Jetrea has shown efficacy in the resolution of VMT and macular hole closure, compared to placebo at day 28 (p<0.001)[1]

Basel, March 18, 2013 - Alcon, the global leader in eye care and a division of Novartis, announces that the European Commission has approved Jetrea®intravitreal injection (ocriplasmin) in the EU for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.[2] VMT is often responsible for progressive sight-threatening symptoms and irreversible vision loss,[3],[4],[5],[6] and is estimated to affect between 250,000 to 300,000 people in Europe alone.[7]

"The approval of Jetrea by the European Commission is a major breakthrough for people with VMT and eye care professionals who, until now, have only had surgical options available to treat this debilitating eye disease. Now they can intervene early with a one-time injection of Jetrea," said Stuart Raetzman, Area President Europe, Middle East and Africa at Alcon. "Jetrea meets a genuine unmet patient need and demonstrates Alcon's commitment to bringing innovative eye care treatments to people in Europe and throughout the world."

The pivotal studies, published in the New England Journal of Medicine, showed that patients who were treated with Jetrea successfully achieved resolution of VMT and closure of macular holes as compared to placebo at day 28.[1] By day 28, 26.5% of the patients treated with Jetrea achieved resolution of VMT (versus 10.1% with placebo [P<0.001]).[1] In addition, 40.6% of the patients treated with Jetrea achieved closure of a macular hole by day 28 (versus 10.6% with placebo [P<0.001]).[1]

Jetrea, a recombinant form of human protein (plasmin), targets the protein fibers which cause the abnormal pull between the vitreous and the macula. By dissolving these proteins, Jetrea separates the vitreous from the macula, releasing VMT and helping to close the macular hole (if present).[2],[8] This one-time injection has been shown to provide early resolution of VMT, including when associated with macular hole of diameter less than or equal to 400 microns.[1],[2]

Side effects observed were consistent with the release of traction and intravitreal injections. The most common adverse events with Jetrea in clinical studies (>2%) included: vitreous floaters, photopsia, conjunctival hemorrhage, injection-related eye pain, blurred vision, reduced visual acuity, and retinal edema. These were generally considered mild to moderate and were resolved without complications.[1]

Alcon, a division of Novartis, acquired the rights to commercialize Jetrea outside the United States from the Belgian biopharmaceutical company ThromboGenics, which retains the rights to commercialize the drug in the US. In October 2012, Jetrea was approved in the US for the treatment of patients with symptomatic vitreomacular adhesion (VMA). On January 14, 2013, ThromboGenics launched Jetrea in the US.

About VMT 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).[9] However, with some people, 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.[9]These areas of vitreomacular adhesion can exert a 'pulling force' on the macula, a condition known as vitreomacular traction (VMT). VMT may eventually lead to the formation of a hole in the macula.[2],[9] VMT is often responsible for progressive sight-threatening symptoms and irreversible vision loss.[3],[4],[5],[6]

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "can," "commitment," or similar expressions, or by express or implied discussions regarding potential additional marketing approvals for Jetreaor 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 Jetreato be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Jetreawill 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 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; 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 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.

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References

[1] 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
[2] Jetrea® Summary of Product Characteristics. ThromboGenics NV. Belgium
[3] Schneider EW, Johnson MW. Emerging nonsurgical methods for the treatment of vitreomacular adhesion: a review. Clin Ophthalmol. 2011;5:1151-1165
[4] Hikichi T, Yoshida A, Trempe C. Course of vitreomacular traction syndrome. Am J Ophthalmol. 1995;119(1):55-61
[5] Carpineto P,Di Antonio L,Aharrh-Gnama A et al. Diagnosing and Treating Vitreomacular Adhesion. Retina 2011 69-73
[6] Bottós, Juliana, et al. Vitreomacular Traction Syndrome. Journal of Opthalmalic and Vision Research. 2012;7(2):148-161
[7] Alcon internal estimates
[8] Data on file, Summary of Clinical Overview. ThromboGenics Inc, 2012
[9] Dugel P. Retina Today April 2012;50

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