ThromboGenics Receives Positive CHMP Opinion for JETREA®
LEUVEN, Belgium, January 18, 2013
LEUVEN, Belgium, January 18, 2013 /PRNewswire/ --
Positive opinion clears the way for the potential EMA approval of JETREA ^®
as the first pharmacological option for the tr eatment of vitreomacular
traction (VMT), including when associated with macular hole of diameter less
than or equal to 400 microns
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical
company focused on developing and commercializing innovative ophthalmic
medicines, today announces that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive
opinion for JETREA ^® (ocriplasmin), recommending JETREA ^® for the treatment
of vitreomacular traction (VMT), including when associated with macular hole
of diameterless than or equal to 400 microns.
VMT, in the US referred to as symptomatic VMA, is an age-related progressive,
sight-threatening condition that may lead to visual distortion, decreased
visual acuity and central blindness. It is estimated that 250,000 to 300,000
patients in Europe alone suffer from this condition. ^[ ^1 ^] ^
JETREA ^® , a recombinant form of a human protein (plasmin), is administered
through a one-time, single intravitreal injection. It targets the protein
fibers which cause the abnormal pulling 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.
Alcon, a division of Novartis, acquired the rights to commercialize JETREA ^®
outside the United States in March 2012. ThromboGenics retains the rights to
commercialize the drug in the US. In the US, JETREA ^® has received FDA
approval for the treatment of patients with symptomatic vitreomacular adhesion
(VMA). Earlier this week, ThromboGenics introduced JETREA ^® in the US. The
first patients have already received this novel treatment in multiple
locations across the country.
" We are very pleased that the CHMP has provided a positive recommendation for
JETREA ^® for the treatment of VMT, including when associated with macular
holes, " says Dr Patrik De Haes, CEO of ThromboGenics. " With our partner
Alcon, ThromboGenics, as the marketing authorization holder, will continue to
work with the European Medicines Agency and the European Commission as it
finalizes the JETREA ^® European Marketing Authorization Application. Today,
more than ever, we are convinced that VMT is an area of unmet medical need.
With today ' s positive CHMP opinion, we anticipate a final decision by the
European Commission within the next 2 to 3 months. The decision will be
applicable to all 27 European Union Member states plus Iceland and
Norway . Upon the Commission ' s final approval and completion of pricing and
reimbursement, we intend to support our partner Alcon in making this novel
treatment option available to patients in the EU as soon as possible, " De
JETREA ^® is used to treat adults with an eye disease called vitreomacular
traction (VMT), including when it is associated with a small hole in the
macula (central part of the light-sensitive layer at the back of the eye).
VMT is caused by traction resulting from a persistent attachment of the
vitreous (jelly-like material in the center of the eye) to the macula at the
back of the eye. The macula provides central vision that is needed for
everyday tasks such as driving, reading and recognising faces. VMT can cause
symptoms such as distorted or decreased vision. When the disease progresses
the traction may eventually result in the formation of a hole in the macula
(called a macular hole).
JETREA ^® works by separating the vitreous humour from the macula, and helping
to close the macular hole if one is present which may decrease the symptoms
caused by VMT.
Currently the only available treatment in the EU is "observation" or "watchful
waiting" until a patient becomes a surgical candidate, usually at a very 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 ^]
" 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
vitrectomy. Upon approval, JETREA ^® will be the first available product with
proven clinical efficacy to release vitreous trac tion, hence provides a
paradigm- shifting treatment option for these eye diseases, " he concludes.
Dr. Albert Augustin, Professor of Ophthalmology and Chairman of the Department
of Ophthalmology at the Klinikum Karlsruhe, Germany , said: " JETREA ^®
represents an important breakthrough for both physicians and patients and is
expected to establish a new standard of care for patients with VMT and small
macular holes. If approved, a single injection of JETREA ^® in the affected
eye could help to prevent disease progression and/or vision loss. "
For patients with VMT and macular holes, everyday activities, such as reading,
driving, the ability to work, use computer screens and overall quality of life
are significantly affected," said Professor Yit Yang, Consultant
Ophthalmologist, Wolverhampton Eye Hospital, and Visiting Professor, Aston
University, UK. "I am looking forward to administering JETREA ^® to
patients who I would normally observe till worsening or progression of the
disease, as we seek to improve their quality of life. "
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.
At day 28, 26.5% Jetrea-treated patients achieved resolution (versus 10.1%
with placebo [P<0.001]). 72% of JETREA ^® patients who achieved resolution of
VMT and macular holes by Day 28, did so within seven days. ^[ ^6 ^]
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
The JETREAEuropean Marketing Authorisation Application is currently under
review by the European Medicines Agency. Following the positive CHMP
recommendation, a final decision by the European Commission on European
approval is expected in the first half of 2013.
ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor),
formerly referred to as TB-403, for the treatment of ophthalmic 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
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