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 /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(R) (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 deteriorates significantly.
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(R) 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 metamorphopsia.
“NICE’s view that metamorphopsia is a ‘severe and distressing’ symptom and that early
treatment with JETREA(R) 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(R), 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
“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(R) 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(R) outside the United States in March 2012. In April 2013,
Alcon launched JETREA(R) in the UK, its first market in Europe, resulting in ThromboGenics
receiving EUR90 million in milestone payments.
JETREA(R) contains the active substance ocriplasmin. It is administered through a
single intravitreal injection to treat adults with vitreomacular traction (VMT).
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 hole).
JETREA(R) breaks down the protein fibers which cause the abnormal traction between the
vitreous and the macula that causes VMT. By dissolving these proteins, JETREA(R) releases
the traction, and helps to complete the detachment of the vitreous from the macula.
JETREA(R) 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., 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.,
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(R) as
soon as it becomes available in the respective countries.
. Idiopathic macular hole. American Academy of Ophthalmology; 2008
. Stalmans P. Management and intervention strategies for symptomatic vitreomacular
adhesions. Retinal Physician 2011
. 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 2011;(Suppl):1-14
JETREA(R) (ocriplasmin) is a truncated form of human plasmin. In the US, JETREA(R) is
indicated for the treatment of symptomatic VMA. In Europe, JETREA(R) is indicated for the
treatment of vitreomacular traction (VMT), including when associated with macular hole of
diameter less than or equal to 400 microns. JETREA(R) 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(R) 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(R) (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(R) outside the United States. Under this agreement,
ThromboGenics could receive up to a total of EUR375 million in up-front and milestone
payments. It will receive significant royalties from Alcon’s net sales of JETREA(R).
ThromboGenics and Alcon intend to share the costs equally of developing JETREA(R) for a
number of new vitreoretinal indications.
In Europe, JETREA(R) 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(R) 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 indications.
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 http://www.thrombogenics.com.
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For further information please contact: Thrombogenics Wouter Piepers, Global Head of Corporate Communications +32-16-75-13-10 / +32-478-33-56-32 Wouter.firstname.lastname@example.org Dr. Patrik De Haes, CEO +32-16-75-13-10 Patrik.email@example.com Chris Buyse, CFO +32-16-75-13-10 Chris.firstname.lastname@example.org Citigate Dewe Rogerson David Dible/ Sita Shah Tel: +44-20-7638-9571 email@example.com The Trout Group (US investor relations) Todd James/ Simon Harnest Tel: +1-646-378-2926 firstname.lastname@example.org
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