ThromboGenics' Partner Alcon Launches JETREA® for the Treatment of Symptomatic
Vitreomacular Adhesion in Canada
LEUVEN, Belgium, November 20, 2013
LEUVEN, Belgium, November 20, 2013 /PRNewswire/ --
Canada is the first market launch for JETREA ^® outside the US and Europe
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical
company focused on developing and commercializing innovative ophthalmic
medicines, today announces that its partner Alcon has launched JETREA®
(ocriplasmin) for the treatment of symptomatic vitreomacular adhesion (VMA) in
Canada. Canada is the first market where JETREA® has been launched outside the
US and Europe.
Symptomatic VMA is estimated to affect up to 15,000 people in Canada each year
^[ ^1 ^] . Health Canada approved JETREA ^® on August 13, 2013 following
Alcon, a division of Novartis, acquired the rights to commercialize JETREA ^®
outside the United States in March 2012. It launched the drug in the UK, its
first European market, in April, followed by launches in Germany, Denmark,
Finland, Norway and Sweden.
ThromboGenics is commercializing the drug in the US and launched JETREA ^® in
the US in mid-January 2013 where it is approved for the treatment of patients
with symptomatic vitreomacular adhesion (VMA).
Dr Patrik De Haes, CEO of ThromboGenics, says: " The launch of JETREA ^®
in Canada, the first market outside the US and Europe, is an another important
step in the global roll out of this innovative new drug for the treatment of
symptomatic VMA. This is a condition where early pharmacological treatment is
being seen as increasingly important in potentially preventing patients '
loss of visual acuity which negatively impacts on their ability to carry out
everyday tasks. We are looking forward to working with Alcon as it continues
to roll out JETREA ^® in other European and Rest of the World markets. "
JETREA ^® contains the active substance ocriplasmin. It is administered
through a one-time, single intravitreal injection to treat adults with
Symptomatic VMA is an age-related progressive, sight-threatening condition. It
is caused by the vitreous having an abnormally strong attachment to the
central part of the retina (the light sensitive membrane at the back of the
eye). The macula provides central vision that is needed for everyday tasks
such as driving, reading and recognizing faces.
When the vitreous shrinks, the strong attachment results in a pulling force on
the retina, which may lead to visual distortion, decreased visual acuity and
central blindness. When the disease progresses the traction may eventually
result in the formation of a hole in the macula (called a macular hole).
JETREA ^® breaks down the protein fibers which cause the abnormal traction
between vitreous and macula. By dissolving these proteins, JETREA ^® releases
the traction, and helps to complete the detachment of the vitreous from the
Currently the only available treatment is 'observation' or 'watchful waiting'
until a patient becomes a surgical candidate, usually at a late stage of the
disease. ^[ ^2 ^] , [ ^3 ^] A patient would then receive a surgical procedure
and repair of the retina. However, for many patients this is not a suitable
option, as irreversible damage to the retina may have already occurred. ^[ ^4
^] , [ ^5 ^]
ThromboGenics continues to work closely with Alcon to support the regulatory
activities and help develop the necessary infrastructure so that patients can
access this innovative medicine and receive JETREA ^® as soon as it becomes
available in the respective countries outside US.
References ^[ ^1 ^] ^. Alcon internal estimates/data on file ^[ ^2 ^] ^.
Idiopathic macular hole. American Academy of Ophthalmology ; 2008 ^[ ^3
^] ^. Stalmans P. Management and intervention strategies for symptomatic
vitreomacular adhesions. Retinal Physician 2011 ^[ ^4 ^] ^. Koerner F & Garweg
J. Vitrectomy for macular pucker and vitreomacular traction syndrome. Doc
Ophthalmol 1999;97:449-458 ^[ ^5 ^] ^. Dugel PU, Brown DM, Humayun MS et al .
Symptomatic vitreomacular adhesion: diagnosis, pathologic implications, and
management. Retina Today 2011; (Suppl):1-14
About JETREA ^® (ocriplasmin)
JETREA ^® (ocriplasmin) is a truncated form of human plasmin. In the US,
JETREA ^® is indicated for the treatment of symptomatic VMA. In Europe, JETREA
^® is indicated for the treatment of vitreomacular traction (VMT), including
when associated with macular hole of diameter ≤ 400 microns. JETREA ^® is a
selective proteolytic enzyme that cleaves fibronectin, laminin and collagen,
three major components of the vitreoretinal interface that play an important
role in vitreomacular adhesion.
JETREA ^® has been evaluated in two multi-center, randomized, double-masked
Phase III trials conducted in the U.S. and Europe involving 652 patients with
vitreomacular adhesion. Both studies met the primary endpoint of resolution of
VMA at day 28.
JETREA's Phase III program found that 26.5% of patients treated with
ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving
placebo (p<0.01). The Phase III program also showed that JETREA was generally
well tolerated with most adverse events being transient and mild in severity.
ThromboGenics is an integrated biopharmaceutical company focused on developing
and commercializing innovative ophthalmic and oncology medicines. The
Company's lead product, JETREA ^® (ocriplasmin), has been approved by the US
FDA for the treatment of symptomatic VMA and was launched in January 2013.
ThromboGenics signed a strategic partnership with Alcon (Novartis) for the
commercialization of JETREA ^® outside the United States. Under this
agreement, ThromboGenics could receive up to a total of €375 million in
up-front and milestone payments. It will receive significant royalties from
Alcon's net sales of JETREA ^® . ThromboGenics and Alcon intend to share the
costs equally of developing JETREA ^® for a number of new vitreoretinal
In Europe, JETREA ^® is approved for the treatment of vitreomacular traction
(VMT), including when associated with macular hole of diameter less than or
equal to 400 microns. Alcon has launched JETREA ^® in the UK, Germany,
Finland, Denmark, Norway and Sweden.
ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor),
also referred to as TB-403, for the treatment of ophthalmic and oncology
ThromboGenics is headquartered in Leuven, Belgium, and has-offices in Iselin,
NJ (US) and Dublin, Ireland. The Company is listed on the NYSE Euronext
Brussels exchange under the symbol THR. More information is available at
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