Microplasmin Meets Primary Endpoint in Second Phase III Trial in VMA, Confirms Positive Findings of First Trial

By Thrombogenics Nv, PRNE
Tuesday, August 31, 2010

Data Presented at ASRS Confirm Previous Phase III Findings and Microplasmin's Potential to Transform the Treatment of Retinal Disorders

LEUVEN, Belgium, September 1, 2010 - ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical
company focused on the discovery and development of innovative treatments for
eye disease, vascular disease and cancer announces that its second Phase III
trial evaluating microplasmin for the non-surgical treatment of vitreomacular
adhesion (VMA) has met its primary endpoint. Importantly, the trial also
confirmed the positive results seen in the first Phase III trial with
microplasmin. The results of the second Phase III trial (TG-MV-007) were
presented for the first time at the American Society of Retina Specialists
(ASRS) Annual Meeting by Dr. J. Michael Jumper (West Coast Retina and Medical
Group and California Pacific Medical Center, California, USA). The trial
recruited 326 patients at 48 centers in Europe and the U.S.

The detailed positive results from the first Phase III trial
in the microplasmin MIVI-TRUST program (TG-MV-006) were presented at the
World Ophthalmology Congress in Berlin in June 2010. The pooled results of
both trials will be presented at the upcoming EURETINA (European Society of
Retina Specialists) Congress in Paris, France, on September 4 by Prof. Peter
(University Hospitals Leuven, Belgium).

In his presentation at ASRS, Dr. Jumper highlighted that the
TG-MV-007 study had met its primary endpoint, with 25.3% of the 245
microplasmin treated patients achieving resolution of their VMA at 28 days,
compared to 6.2% of the 81 patients who received a placebo injection, a
highly statistically significant result (p=0.001). In patients without
epiretinal membrane, microplasmin was shown to be even more effective with
34.5% of patients seeing resolution of their VMA at 28 days, compared to 6.4%
of placebo treated patients. 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 TG-MV-007 trial also showed that microplasmin was highly
effective in treating patients who had been diagnosed with full thickness
macular hole (FTMH). In this group, 36.7% of the 49 patients saw closure of
their FTMH at 28 days following a single 125g micro injection of
microplasmin, without the need for a vitrectomy. This compares with 6.7% of
the 15 patients in the placebo group (p= 0.028). These positive results are
in line with what was achieved in this patient group in the TG-MV-006 study.

The TG-MV-007 study also evaluated the visual acuity (VA) of
patients. This analysis showed that at the end of the study 22.0% 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
11.1% of the patients who received a placebo injection (p<0.05). Within the
microplasmin treated population, 9% of patients achieved a 15 letter (3
lines) improvement in their visual acuity without the need for vitrectomy, a
level of nonsurgical improvement that was not seen in any of the patients who
received placebo (p<0.005). In addition, microplasmin treated patients showed
an improved Quality of Life when compared to placebo, based on the VFQ-25
(National Eye Institute Visual Functioning Questionnaire) results.

The TG-MV-007 study confirmed that microplasmin was generally
safe and well tolerated. Importantly, consistent with the findings of the
TG-MV-006, there was no evidence of an increased risk of retinal tear or

Dr. Patrik De Haes, CEO of ThromboGenics, commented, "I am
very pleased that the results from the TG-MV-007 study announced yesterday
have confirmed the positive findings of the first Phase III trial and clearly
show microplasmin's potential to make a significant impact on the treatment
of vitreoretinal disorders. Over the next several months, key investigators
who participated in the studies will be presenting the exciting data from the
overall MIVI-TRUST program to the global retina community at a number of
major international ophthalmology congresses. Given the success of the
overall Phase III clinical program, I am extremely confident that
microplasmin has the potential to provide both patients and retina
specialists with a highly attractive treatment option for a broad range of
retinal disorders."

Dr. J. Michael Jumper, commenting on his presentation at the
ASRS, said, "These results confirm microplasmin's potential to treat patients
with macular disease caused by vitreous traction, including full thickness
macular hole (a condition which currently requires major eye surgery to
prevent irreversible vision loss), with a single intravitreal injection, a
very appealing option when compared to surgery."

16th Annual Gertrude D. Pyron Award for Outstanding
Achievement in Retina Research

Dr. Julia Haller (Ophthalmologist-in-Chief, Wills Eye
Institute, and Professor and Chair of Department of Ophthalmology of Thomas
Jefferson University
, Philadelphia), was presented with the 16th Annual
Gertrude D. Pyron Award for Outstanding Achievement in Retina Research at
ASRS. At the meeting, she chose to discuss microplasmin as a treatment option
for retinal diseases in the Pyron Lecture entitled, "Ties That Bind: The
Vitreo-Retinal Relationship." The lecture, which took place on August 29,
centered on the positive results of the microplasmin Phase III program, with
particular focus on the wealth of new information about the vitreoretinal
interface that the MIVI-TRUST program has generated and its implications for
the vitreoretinal surgeon.

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
125g micro 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 www.thrombogenics.com.

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 thrombogenics.com; Dr. Patrik De Haes, CEO, Tel: +32-16-75-13-10, patrik.dehaes at thrombogenics.com; Citigate Dewe Rogerson, Amber Bielecka/ David Dible/ Nina Enegren, Tel: +44(0)207-638-95-71, amber.bielecka at citigatedr.co.uk

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