Jetrea(TM) receives positive CHMP opinion, would become the first drug to treat sight-threatening vitreomacular traction and macular hole
Novartis International AG /
Jetrea(TM) receives positive CHMP opinion, would become the first drug to treat
sight-threatening vitreomacular traction and macular hole
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.
* Pivotal data showed Jetrea significantly resolved vitreomacular traction
(VMT) and macular hole compared to placebo at day 28 (p<0.001)
* Current standard of care for VMT is surgery or "watchful waiting" associated
with further visual impairment that can lead to central blindness,,
* Anticipated approval of Jetreaconfirms Alcon's commitment to providing
innovative treatments to address the world's unmet clinical needs in eye
Basel, January 18, 2013 - Alcon, the global leader in eye care and a division of
Novartis, announces the positive opinion from the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA) for
Jetrea(TM) (ocriplasmin), for the treatment of vitreomacular traction (VMT),
including when associated with macular hole of diameter less than or equal to
400 microns. VMT is an age-related progressive condition that may lead to visual
distortion, decreased visual acuity and central blindness, if left untreated. It
is estimated that 250,000 to 300,000 patients in Europe suffer from this sight-
Separation of the vitreous, a jelly-like substance within the eye, and the
macula, the light-sensitive part at the back of the eye responsible for central
vision, occurs as part of the natural aging process and is common in people over
the age of 50. If the vitreous fails to detach completely, it can place
mechanical stress (traction) on the macula, and can even tear the macula,
resulting in a macular hole, if not resolved.
Jetrea, a recombinant form of human protein (plasmin), is administered through a
one-time, single intravitreal injection. It targets the protein fibers which
cause the abnormal pull between vitreous and macula. By dissolving these
proteins, Jetrea releases the traction, and helps to complete the detachment of
the vitreous from the macula.
"We are excited to bring this innovative treatment to patients in Europe who
live with VMT and macular hole and for whom there has been limited prospect of
treatment," said Sabri Markabi, Senior Vice President, Research and Development
at Alcon. "This demonstrates Alcon's steadfast commitment to addressing unmet
patient needs in the field of eye care. Europe will be the first region outside
the US where we expect Jetrea to be approved and our goal is to make this
treatment accessible to many more patients around the world."
Currently the only available treatment in the EU is 'observation' or 'watchful
waiting' until a patient becomes eligible for surgical intervention at a very
late stage of the disease, which includes a vitrectomy (removal of the
vitreous from the eye) and repair of the retina (innermost layer located in the
back of the eye). However, for many patients this is not a suitable option, and
damage to the retina may have already occurred.,
"For patients with VMT and macular hole, activities of daily living, such as
reading, driving, the ability to work, use computer screens and overall quality
of life are significantly affected," said Professor Yit Yang, Consultant
Ophthalmologist, Royal Wolverhampton Eye Hospital, and Visiting Professor, Aston
University, UK. "Jetrea represents an important breakthrough for both patients
and retinal specialists and represents a paradigm-shift in this area of retinal
therapy and clinical practice."
The EU regulatory submission was based on data from two pivotal Phase III
clinical trials that evaluated the safety and efficacy of a single
administration of Jetrea. Both studies met their primary endpoint and
demonstrated that Jetrea successfully resolved VMT and macular hole compared to
placebo. At day 28, 26.5% of Jetrea-treated patients achieved resolution of VMT
(versus 10.1% with placebo [P<0.001]). 72% of Jetrea patients who achieved
resolution by day 28, did so within seven days.
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
Alcon, a division of Novartis, acquired the rights to commercialize Jetrea
outside the United States from the Belgian biopharmaceutical company
ThromboGenics, who 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.
The foregoing release contains forward-looking statements that can be identified
by terminology such as "would," "anticipated," "commitment," "expect," "hope,"
"expected," "potential," "will,", "our goal", or similar expressions, or by
express or implied discussions regarding potential marketing submissions or
approvals for ocriplasmin or regarding potential future revenues from
ocriplasmin. You should not place undue reliance on these statements. Â 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 ocriplasmin to be materially
different from any future results, performance or achievements expressed or
implied by such statements. There can be no guarantee that ocriplasmin will be
submitted or approved for sale in any market, or at any particular time. Nor can
there be any guarantee that ocriplasmin will achieve any particular levels of
revenue in the future. In particular, management's expectations regarding
ocriplasmin 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; competition in general; government, industry
and general public pricing pressures; unexpected manufacturing issues; the
company's ability to obtain or maintain patent or other proprietary intellectual
property protection; 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.
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 billion in 2011.
Headquartered in Fort Worth, Texas, USA, Alcon has more than 24,000 employees
worldwide, operations in 75 countries and products available in 180 markets. For
more information, visit www.alcon.com.
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 2011, the Group
achieved net sales of USD 58.6 billion, while approximately USD 9.6 billion (USD
9.2 billion excluding impairment and amortization charges) was invested in R&D
throughout the Group. Novartis Group companies employ approximately 127,000
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 @Novartis at
 Stalmans P, Benz MS, Gandorfer A et al. Enzymatic vitreolysis with
ocriplasmin for vitreomacular traction and macular holes. N Engl J Med
 Idiopathic macular hole. American Academy of Ophthalmology; 2008.
Stalmans P. Management and intervention strategies for symptomatic
vitreomacular adhesions. Retinal Physician 2011.
 Hikichi T, Yoshida A, Trempe CL. Course of vitreomacular traction syndrome.
Am J Ophthalmol 1995;119:55-61.
 Alcon internal estimates
 Koerner F & Garweg J. Vitrectomy for macular pucker and vitreomacular
traction syndrome. Doc Ophthalmol 1999;97:449-458.
 Dugel PU, Brown DM, Humayun MS et al. Symptomatic vitreomacular adhesion:
diagnosis, pathologic implications, and management. Retina Today
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
Eric Althoff Heidi De Wit
Novartis Global Media Relations Alcon Global Media Relations
+41 61 324 7999 (direct) +1 817 615 2976 (direct)
+41 79 593 4202 (mobile) +1 972 955 7073 (mobile)
For Novartis multimedia content, please visit www.thenewsmarket.com/Novartis
For questions about the site or required registration, please contact:
Novartis Investor Relations
Central phone: +41 61 324 7944
Samir Shah +41 61 324 7944 North America:
Pierre-Michel Bringer +41 61 324 1065 Helen Boudreau +1 212 830 2404
Thomas Hungerbuehler +41 61 324 8425 Jill Pozarek +1 212 830 2445
Isabella Zinck +41 61 324 7188 Edwin Valeriano +1 212 830 2456
e-mail: email@example.com e-mail:
Media release (PDF):
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Novartis International AG via Thomson Reuters ONE