ThromboGenics' JETREA® Granted EU Approval for Vitreomacular Traction (VMT),
Including When Associated With Macular Hole of Diameter Less Than or Equal to
LEUVEN, Belgium, March 15, 2013
LEUVEN, Belgium, March 15, 2013 /PRNewswire/ --
EU approval of JETREA ^® triggers a €45 million milestone payment from Alcon
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical
company focused on developing and commercializing innovative ophthalmic
medicines, today announces that the European Commission has approved JETREA ^®
(ocriplasmin) in the European Union. 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. The EU approval triggers a €45
million milestone payment to ThromboGenics from its partner Alcon. The first
sale of JETREA ^® in the EU by Alcon will trigger a further €45 million
milestone payment to ThromboGenics.
Alcon, a division of Novartis, acquired the rights to commercialize JETREA ^®
outside the United States in March 2012. ThromboGenics retains the right to
commercialize the drug in the US. ThromboGenics 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 European approval of
JETREA ^® just weeks after the US launch is another major milestone for
the Company as we maintain, with our partner Alcon, the momentum of the global
roll out of this novel pharmacological treatment for symptomatic VMA. Today '
s approval has triggered a €45 million milestone payment to ThromboGenics. We
also anticipate a further €45 million as a result of Alcon ' s first sale of
the product in the EU which is expected to take place soon. Patients across
Europe will now have access to our innovative drug for an important
sight-threatening condition. VMT is a considerable unmet medical need and
places a huge burden on patients across Europe who until now have had no
treatment option other than watchful waiting or surgery. "
JETREA ^® contains the active substance ocriplasmin. It is administered
through a one-time, single intravitreal injection to treat adults with
vitreomacular traction (VMT).
VMT, which in the US is referred to as symptomatic VMA, is an age-related
progressive, sight-threatening condition. It is caused by the vitreous humour
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
When the vitreous humour 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
JETREA ^® breaks down the protein fibers which cause the abnormal traction
between vitreous and macula that causes VMT. By dissolving these proteins,
JETREA ^® releases the traction, and helps to complete the detachment of the
vitreous from the macula.
JETREA ^® can also be used when VMT has progressed and caused a small hole in
the macula (central part of the light-sensitive layer at the back of the eye).
It is estimated that 250,000 to 300,000 patients in Europe alone suffer from
this condition. ^[ ^1 ^] ^
Currently the only available treatment in the EU 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 is continuing to work with Alcon, across Europe, to ensure the
necessary market access and reimbursement infrastructure in place so that
patients can receive JETREA ^® as soon as it is available.
" Vitreomacular traction and macular hole formation are disabling eye diseases
that influence visual function, and affect activities of patients in their
daily life ," said Prof. Dr. Peter Stalmans, Department of Ophthalmology,
University Hospitals , Leuven , Belgium . " When the disease worsens,
vitrectomy surgery is the only available treatment option. Release of the
vitreous traction by pharmacologic vitreolysis can omit the need for
" The EU approval of JETREA ^® is a very positive development for patients
with VMT and the wider European retina community. This novel pharmacological
approach will enable us to improve the treatment of VMT by allowing patients
to be treated earlier thereby avoiding the deterioration in their condition
that takes place during watchful waiting as well as the risks associated with
the surgery. I am looking at quickly integrating the use of JETREA ^® into
my clinical practice as soon as it becomes available ."
The EU MAA 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 holes compared to placebo.
All adverse reactions were ocular. The most commonly reported were vitreous
floaters, eye pain and photopsia, as well as conjunctival haemorrhage
resulting from the injection procedure. Most of the adverse reactions occurred
within the first week after the injection. The majority of these reactions
were non-serious, mild in intensity and resolved within 2to 3weeks. ^[ ^6 ^]
^[ ^1 ^] ^. ThromboGenics and Alcon internal estimates
^[ ^2 ^] ^. Idiopathic macular hole. American Academy of Ophthalmology ;
^[ ^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
^[ ^6 ^] ^. Stalmans P, Benz MS, Gandorfer A et al. Enzymatic vitreolysis with
ocriplasmin for vitreomacular traction and macular holes. N Engl J Med
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 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.
In March 2012, 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
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.
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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