Alcon announces EU approval of Jetrea®, first and only eye drug to treat sight-threatening vitreomacular traction and macular hole
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Novartis International AG /
Alcon announces EU approval of Jetrea®, first and only eye drug to treat
sight-threatening vitreomacular traction and macular hole
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The issuer is solely responsible for the content of this announcement.
* 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.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
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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Unternehmensinformation / Kurzprofil:
Datum: 18.03.2013 - 07:15 Uhr
Sprache: Deutsch
News-ID 240068
Anzahl Zeichen: 11675
contact information:
Town:
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