ThromboGenics Presents Positive Pooled Results from the MIVI-TRUST Phase III Program, Confirming Microplasmin's Potential to Transform the Treatment of Retinal Disorders

By Thrombogenics Nv, PRNE
Sunday, September 5, 2010

Data Presented at EURETINA Highlight the Attractive Characteristics of this Novel Potential Treatment Option for Retinal Disorders

LEUVEN, Belgium, September 6, 2010 - ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical
company focused on the discovery and development of innovative treatments for
eye disease, cardiovascular disease and cancer, announces that the pooled
results from the successful microplasmin MIVI-TRUST Phase III program were
presented today at the EURETINA (European Society of Retina Specialists)
Congress in Paris, France. The MIVI-TRUST program is the largest
interventional clinical program ever performed to specifically evaluate the
vitreoretinal interface in patients with retinal disorders, recruiting a
total of 652 patients at 90 centers across the U.S. and Europe.

The pooled results of the TG-MV-006 and TG-MV-007 Phase III
trials were presented by Prof. Peter Stalmans (University Hospitals Leuven,
Belgium). These results demonstrate the potential of microplasmin to
transform the treatment of a range of retinal disorders.

    The Phase III program showed that microplasmin:

    - Was successful in resolving vitreomacular adhesion (VMA)
    - Was able to cure full thickness macular hole (FTMH) without the
      need for surgery
    - Delivered an improvement in the vision of patients without the
      need for surgery
    - Was safe and well tolerated

Both the TG-MV-006 and TG-MV-007 trials met the primary
endpoint, achieving a statistically significant improvement in the resolution
of VMA. The pooled results from the MIVI-TRUST program showed that 26.4% of
the 465 microplasmin treated patients achieved resolution of their VMA at 28
days, compared to 10.2% of the 182 patients who received a placebo injection,
a highly statistically significant result (p=0.000002).

In patients without epiretinal membrane, microplasmin was
shown to be even more effective, with 37.4% of 270 patients achieving
nonsurgical resolution of their VMA at 28 days, compared to 14.3% of 119
placebo treated patients (p=0.000003). Epiretinal membrane is a layer of scar
tissue which builds up on the macula, making it more difficult to achieve
resolution of VMA without surgical intervention. Epiretinal membrane can be
easily identified using Optical Coherence Tomography (OCT).

The MIVI-TRUST program's pooled results also highlighted
microplasmin's impressive effect in patients diagnosed with FTMH. In this
group, 40.6% of the 106 patients saw closure of their FTMH at 28 days
following a single 125micro-g injection of microplasmin without the need for a
vitrectomy. This compares with 10.6% of the 47 patients in the placebo group
(p= 0.00015). The closure of FTMH also led to microplasmin treated patients
experiencing a significant improvement in their visual acuity (VA) compared
to baseline.

Prof. Stalmans also presented an analysis of the pooled visual
acuity data from the Phase III program. This showed that at the end of the
six month study period, 23.7% of the microplasmin treated patients had
achieved at least a 10 letter (2 lines) improvement in VA without the need
for vitrectomy. This compares to only 11.2% of the patients who received a
placebo injection (p=0.0002). Within the microplasmin treated population,
9.7% of patients achieved a 15 letter (3 lines) improvement in their visual
acuity without the need for vitrectomy, compared to just 3.7% of the placebo
patients (p=0.01). In addition, microplasmin treated patients showed an
improved Quality of Life when compared to placebo, based on the VFQ-25 (the
National Eye Institute Visual Functioning Questionnaire) results.

The pooled results also confirmed that microplasmin was
generally safe and well tolerated. There was no evidence of an increased risk
of retinal tear or detachment.

Dr. Patrik De Haes, CEO of ThromboGenics, commented, "The
successful completion and reporting of our 652 patient Phase III program with
microplasmin in just 20 months demonstrates ThromboGenics' highly effective
drug development capabilities. The pooled data presented today clearly show
that microplasmin could make a significant difference to the treatment of
vitreoretinal disorders. The results from these pivotal trials will form the
central part of the packages that we plan to submit to the FDA and EMA by mid
2011 to support our applications for marketing approval. Given the success of
the overall Phase III clinical program and our plans to market microplasmin
ourselves both in the U.S. and Europe, we are now gearing up our
pre-marketing activities and our commercial organization. Based on these
exciting results and our discussions with many leading retinal specialists, I
am convinced that microplasmin has the potential to become a highly
attractive treatment option for a broad range of retinal disorders."

Prof. Peter Stalmans, commenting on his presentation at
EURETINA, said, "I am delighted to have presented these pooled results for
the first time. Based on these exciting Phase III results and my own personal
experience, I have little doubt that microplasmin will quickly become an
important treatment option for patients with a range of retinal disorders,
including macular hole. The benefits of this simple one-off injection are
very appealing, when compared to surgery, to both patients and retina

Notes to Editors

About Focal Vitreomacular Adhesion (VMA)

Focal vitreomacular adhesion is a condition in which the
vitreous gel, in the center of the eye, has an abnormally strong adhesion to
the macula, the center of the retina at the back of the eye. Vitreomacular
adhesion plays a key role in numerous back of the eye conditions, such as
macular hole and some forms of macular edema. Vitreomacular adhesion is also
associated with a worse prognosis in certain major eye conditions, including
Diabetic Retinopathy and Age-related Macular Degeneration (AMD).

About Macular Hole

Focal vitreomacular adhesion can lead to macular hole, where
the traction from the vitreomacular adhesion actually pulls off a piece of
the macula (the part of the retina responsible for central vision). If not
treated with major eye surgery called a vitrectomy, which involves using
suction to remove the vitreous from the eye, macular hole can lead to
irreversible, central blindness. While vitrectomy is generally effective in
closing macular holes, it is an invasive procedure and a proportion of
patients experience side-effects. These include alteration of vision,
bleeding, retinal detachment and development of glaucoma and cataracts.
Therefore, a nonsurgical treatment option for such patients could be an
important breakthrough in the way macular hole patients are treated.

The MIVI-TRUST Program

The microplasmin Phase III program, referred to as MIVI-TRUST
(Microplasmin for IntraVitreous Injection-Traction Release without Surgical
Treatment), consists of two multi-center, randomized, placebo controlled,
double-masked trials. These trials are designed to evaluate a single dose of
125μg microplasmin versus placebo in the intravitreal treatment of patients
with symptomatic focal vitreomacular adhesion (VMA). The primary endpoint of
both trials is the non-surgical resolution of focal vitreomacular adhesion
one month after a single injection of microplasmin. This endpoint is assessed
using optical coherence tomography (OCT). The MIVI-TRUST program is the
largest interventional clinical program ever performed to specifically
evaluate the vitreoretinal interface in patients with retinal disorders. In
total, over 650 patients were enrolled in these trials, which were held
across 90 centers in 7 countries.

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
has completed two Phase III clinical trials for the non-surgical treatment of
retinal disorders. 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 in Phase II, and TB-403 (anti-PlGF) in Phase Ib/II for
cancer in partnership with Roche.

ThromboGenics is headquartered in Leuven, Belgium. The Company
is listed on Eurolist by 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.

    For further information please contact:


    Dr. Steve Pakola, CMO                     Tel: +1-212-201-0920

    Dr. Patrik De Haes, CEO                   Tel: +32-16-75-13-10

    Citigate Dewe Rogerson

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

For further information please contact: ThromboGenics, Dr. Steve Pakola, CMO, Tel: +1-212-201-0920, steve.pakola at; Dr. Patrik De Haes, CEO, Tel: +32-16-75-13-10, patrik.dehaes at; Citigate Dewe Rogerson, Amber Bielecka/David Dible/Nina Enegren, Tel: +44(0)207-638-95-71, amber.bielecka at

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