ThromboGenics Announces Start of Phase II Trial of Microplasmin for the Treatment of Age-Related Macular Degeneration (AMD)

By Thrombogenics Nv, PRNE
Thursday, December 10, 2009

LEUVEN, Belgium, December 11 - ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical
company focused on innovative medicines for eye disease, vascular disease and
cancer, announces today that it has started a Phase II trial of microplasmin
for the treatment of exudative (wet) Age-related Macular Degeneration (AMD).

Wet AMD affects approximately five million patients worldwide
and this patient population is continuing to grow. Wet AMD occurs when
abnormal blood vessels behind the retina start to grow under the macula, the
central area of the retina responsible for detailed vision. These blood
vessels are often fragile and can leak blood and fluid below the macula,
causing damage to the photoreceptors and vision loss. AMD, a disease
associated with aging, gradually destroys a patient's vision. It is the most
common cause of vision loss in patients aged 50 or older, and represents a
market of over $1 billion annually.

Abnormalities in the vitreomacular interface (the interface of
the vitreous and macula) have been implicated in wet AMD, and recent
publications have demonstrated that approximately one-third of AMD patients
have focal vitreomacular adhesion (VMA). VMA is a condition in which the
vitreous gel, in the center of the eye, has an abnormally strong adhesion to
the retina at the back of the eye, and research has found that this adhesion
occurs in the same location as the wet AMD pathology.[1]

ThromboGenics is developing microplasmin as a non-surgical
treatment for vitreomacular adhesion. Microplasmin has the potential to
separate the vitreous from the retina and, as wet AMD is thought to result
from the abnormal connection of the vitreous to the retina, it is therefore
anticipated that microplasmin could potentially prevent the progression of
this highly prevalent disease.

The MIVI 5 (Microplasmin for IntraVitreous Injection) trial is
a Phase II, randomized, double-blind, sham controlled trial of microplasmin
intravitreal injection (125 μg) for the treatment of focal vitreomacular
adhesion (separation of the vitreous from the retina) in patients with
exudative (wet) AMD. The trial will enroll approximately 100 patients at up
to 20 centers across five European countries. The primary endpoint of the
trial is non-surgical resolution of vitreomacular adhesion, defined as the
separation of the vitreous from the retina by 28 days. This will be assessed
by the Central Reading Center based on optical coherence tomography (OCT)
images. Additional measures of efficacy and safety will also be assessed over
a one year follow-up period.

Microplasmin has the potential to transform the treatment of a
number of other important back of the eye diseases as well as AMD.
Microplasmin is currently being evaluated in a Phase III program of
approximately 640 patients, for the non-surgical treatment of focal
vitreomacular adhesion.

Dr. Patrik De Haes, CEO of ThromboGenics commenting on the
announcement said, "We are very pleased to announce the start of a Phase II
trial of microplasmin in such a significant condition as AMD. It is
increasingly clear that vitreomacular adhesion plays a key role in AMD
sufferers with a poorer prognosis. Microplasmin's potential to cleave the
vitreous from the retina could therefore represent an important advance in
the treatment of this patient group. The start of this trial underlines the
potential broad applicability of our lead product, and is another important
step as we create a profitable integrated company focused on cutting edge
ophthalmic medicines."

About ThromboGenics

ThromboGenics is a biopharmaceutical company focused on the
discovery and development of innovative medicines for the treatment of eye
disease, vascular disease and cancer. The Company's lead product microplasmin
is in Phase III clinical development for the non-surgical treatment of back
of the eye diseases. Microplasmin is also being evaluated in Phase II
clinical development for additional vitreoretinal conditions. In addition,
ThromboGenics is developing novel antibody therapeutics in collaboration with
BioInvent International; these include TB-402 (Anti-Factor VIII), a long
acting anti-coagulant, and TB-403 (anti-PlGF) for cancer.

ThromboGenics has built strong links with the University of
Leuven and the Flanders Institute for Biotechnology (VIB) and has exclusive
rights to certain therapeutics developed at these institutions. ThromboGenics
is headquartered in Leuven, Belgium. The Company is listed on NYSE Euronext
Brussels under the symbol THR. More information is available at

Important information about forward-looking statements

Certain statements in this press release may be considered
"forward-looking". Such forward-looking statements are based on current
expectations, and, accordingly, entail and are influenced by various risks
and uncertainties. The Company therefore cannot provide any assurance that
such forward-looking statements will materialize and does not assume an
obligation to update or revise any forward-looking statement, whether as a
result of new information, future events or any other reason. Additional
information concerning risks and uncertainties affecting the business and
other factors that could cause actual results to differ materially from any
forward-looking statement is contained in the Company's Annual Report.

[1] Robison CD et al, 2009; Mojana J et al, 2008; Krebs I et al, 2007

For further information please contact:


    Dr. Patrik De Haes, CEO                   Tel: + 32-16-75-13-1
    Dr. Steve Pakola, CMO                     Tel: +1(212)201-0920

    Citigate Dewe Rogerson
    Amber Bielecka/ David Dible/ Nina Enegren Tel: +44(0)207-638-95-71

ThromboGenics: Dr. Patrik De Haes, CEO, Tel: + 32-16-75-13-1, patrik.dehaes at; Dr. Steve Pakola, CMO, Tel: +1(212)201-0920, steve.pakola at; Citigate Dewe Rogerson: Amber Bielecka/ David Dible/ Nina Enegren Tel: +44(0)207-638-95-71, amber.bielecka at

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