National Institute for Health and Care Excellence (NICE) in the UK Recommends
Reimbursing ThromboGenics' JETREA® for Treatment of a Broad Range of Patients
with Vitreomacular Traction (VMT), Including When Associated With Macular Hole
LEUVEN, Belgium, October 23, 2013
LEUVEN, Belgium, October 23, 2013 /PRNewswire/ --
Final guidance confirms metamorphopsia, an early symptom of VMT, as severe and
distressing, requiring early treatment
*NICE final guidance recommends reimbursement of JETREA for treatment of a
broad range of VMT patients, from early stage to late-stage: patients with
epiretinal membranes (ERMs) are excluded
*NICE recommends reimbursement for patients suffering from VMT with full
thickness macular hole (FTMH) < 400 microns
*NICE recommends reimbursement of JETREA for treatment of patients showing
early symptoms of VMT such as metamorphopsia (blurred vision); NICE
considers patient impact of metamorphopsia to be equal to the loss of two
lines in visual acuity
ThromboGenics NV (Euronext Brussels: THR) a biopharmaceutical company focused
on developing and commercializing innovative ophthalmic medicines, announces
that the UK's National Institute for Health and Care Excellence (NICE) final
guidance has recommended that JETREA ^® (ocriplasmin) should be reimbursed
within the National Health Service (NHS) in England and Wales as an option for
treating VMT patients.JETREA has been marketed by ThromboGenics partner,
Alcon, mainly to private hospitals in the UK since April 2013. ^
The NICE final guidance again highlighted metamorphopsia as a 'severe and
distressing' symptom, with its impact on the patient being comparable to a
loss of two lines in visual acuity. In its final ruling NICE has recommended
reimbursing JETREA when used to treat patients suffering from metamorphopsia,
one of the early signs of VMT.
Currently patients with VMT are observed (termed watch and wait) before they
are considered eligible for surgery. Surgery is only performed at a later
stage of a patient's disease, once symptoms progress and their sight
Dr Patrik De Haes, CEO of ThromboGenics , said: " We are very pleased with
NICE ' s final guidance recommending that the NHS in England and Wales should
reimburse the use of JETREA ^® for a broad range of patients with VMT and
macular hole. This outcome marks the start of a paradigm shift in treatment as
it means that physicians will be able to use the first and only
pharmacological option to proactively treat this progressive disease much
earlier and as soon as patients start experiencing symptoms such as
"NICE's view that metamorphopsia is a 'severe and distressing' symptom and
that early treatment with J ETREA ^® should be reimbursed is in line with
our own view that this novel drug delivers significant clinical and quality of
life benefits to patients with VMT.
"There is growing evidence that if left untreated prolonged VMT may lead to
progressive vision loss and importantly, an increased risk that subsequent
intervention may be less successful. With JETREA ^® , an innovative new drug,
we believe that patients will be able to benefit, for the first time, by
having access to a reimbursed alternative to watchful waiting. We are
confident that today's NICE recommendation will lead to a significant change
in the way this important sight-threatening condition is treated in the UK. "
"People affected by vitreomacular traction can suffer vision changes that have
a significant impact on their lives, making it difficult to do everyday
activities like reading, watching TV and driving, " said Tim Jackson, Retinal
Surgeon at King's College Hospital . " Until now, eye doctors have only had
surgical options to treat this disease, once it progressed to a severe stage.
This new treatment is a welcome advance, meaning some patients can now avoid
surgery, and others who might not be suitable for surgery can now be treated.
JETREA ^® is the first and only potentially curative pharmacological treatment
indicated for use in patients diagnosed with VMT, including when associated
with macular hole of diameter less than or equal to 400 microns and was
approved in the European Union by the European Commission in March 2013.
Alcon, a division of Novartis, acquired the rights to commercialize JETREA ^®
outside the United States in March 2012. In April 2013, Alcon launched JETREA
^® in the UK, its first market in Europe, resulting in ThromboGenics receiving
€90 million in milestone payments.
JETREA ^® contains the active substance ocriplasmin. It is administered
through a single intravitreal injection to treat adults with vitreomacular
VMT is a progressive, sight-threatening condition. It is caused by the
vitreous humor having an abnormally strong attachment to the macula, 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 humor 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 the vitreous and the 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).
The current approach in the EU is 'observation', 'watchful waiting' or 'watch
and wait' until a patient becomes a candidate for surgical treatment, usually
at a late stage of the disease. ^[ ^1 ^] ^, ^[ ^2 ^] 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. ^[ ^3 ^] ^, ^[ ^4 ^]
ThromboGenics is continuing to work closely with Alcon to ensure patients
across Europe and rest of the world can access this innovative medicine and
receive JETREA ^® as soon as it becomes available in the respective countries.
^[ ^1 ^] ^. Idiopathic macular hole. American Academy of Ophthalmology ;
^[ ^2 ^] ^. Stalmans P. Management and intervention strategies for symptomatic
vitreomacular adhesions. Retinal Physician 2011
^[ ^3 ^] ^. Koerner F & Garweg J. Vitrectomy for macular pucker and
vitreomacular traction syndrome. Doc Ophthalmol 1999;97:449-458
^[ ^4 ^] ^. Dugel PU, Brown DM, Humayun MS et al . Symptomatic vitreomacular
adhesion: diagnosis, pathologic implications, and management. Retina Today
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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For further information please contact:
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