ThromboGenics' JETREA® Receives Positive Initial NICE Recommendation for
Vitreomacular Traction and Macular Hole
LEUVEN, Belgium, June 12, 2013
LEUVEN, Belgium, June 12, 2013 /PRNewswire/ --
ThromboGenics NV (Euronext Brussels: THR) a biopharmaceutical company focused
on developing and commercializing innovative ophthalmic medicines, announces
today that the UK's National Institute for Health and Care Excellence (NICE)
has provisionally recommended JETREA ^® (ocriplasmin) for reimbursement within
the National Health Service (NHS). The NICE Appraisal Consultation Document
(ACD) initially recommends JETREA ^® as an option for treating vitreomacular
traction (VMT) in adults, including when associated with a macular hole of
less than or equal to 400microns, when patients have severe symptoms and an
epiretinal membrane is not present.
JETREA ^® is the first pharmacological treatment indicated for use in patients
diagnosed with VMT and 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. Partner Alcon launched the drug in the UK, its first market in
Europe, in April, resulting in ThromboGenics receiving €90 million in
milestone payments. Alcon, a division of Novartis, acquired the rights to
commercialize JETREA ^® outside the United States in March 2012.
The NICE appraisal committee considers evidence submitted by the manufacturer
and makes a judgment on whether or not the technology should be recommended as
a clinically and cost-effective use of NHS resources, or whether it should
only be recommended for specific subgroups of patients. This process also
takes into account testimony from clinical experts, patient groups and carers.
After publication of the ACD, NICE invites formal consultees, commentators and
the general public to comment on the ACD. After considering these comments,
the Committee then finalizes its recommendations and submits them to NICE in
the form of a Final Appraisal Determination (FAD). The final NICE guidance on
JETREA ^® is expected in the third quarter of 2013.
Dr Patrik De Haes, CEO of ThromboGenics , said: " We are delighted by the
preliminary NICE recommendation for JETREA ^® , the first and only
pharmacological treatment licensed for VMT and macular hole. The Institute has
concluded that treatment with JETREA ^® early in the course of the disease
represents a step-change in how patients with VMT are currently managed,
preserving visual function and quality of life for patients with this
distressing, sight-threatening condition. We particularly welcome NICE ' s
endorsement that JETREA ^® is a cost-effective use of finite NHS
resources, and represents good value for money in the patients in whom it is
" People affected by VMT and macular hole can suffer significant vision
distortion that can make it difficult for them to read, watch TV and drive.
The draft NICE recommendation published today is important in improving their
treatment options. For suitable patients it offers a simple treatment that may
avoid the need for eye surgery, and means patients unsuited to surgery can now
be treated, often before their condition deteriorates, " said Mr Tim Jackson,
Consultant Retinal Surgeon at King's College Hospital.
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 humour 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).
It is estimated that 250,000 to 300,000 patients in Europe alone suffer from
this condition. ^[ ^1 ^] ^
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. ^[ ^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 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 ^] ^. 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
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 and Germany.
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:
Thrombogenics Wouter Piepers, Global Head of Corporate Communications
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