- Paper Examines the Potential of Microplasmin to Improve the Treatment
of a Range of Back of the Eye Diseases
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 today that the positive
microplasmin Phase II trial results, evaluating the product's efficacy and
safety in patients who require vitrectomy, have been published in the
prestigious American Academy of Ophthalmology's Journal, Ophthalmology, the
leading journal for the vitreoretinal community.
A paper entitled "A Placebo-Controlled Trial of Microplasmin
Intravitreous Injection to Facilitate Posterior Vitreous Detachment Before
Vitrectomy" has been published online ahead of print in Ophthalmology. This
publication covers the Phase II trial (MIVI III) with microplasmin, with the
objective of evaluating the efficacy and safety of intravitreal microplasmin
in facilitating the separation of the vitreous from the retina. The
separation of the vitreous from the retina is used to treat a range of back
of the eye disorders and is achieved currently via a surgical procedure
called a vitrectomy.
The paper showed that the highest dose of microplasmin (125microg) led to
a greater likelihood of induction and progression of PVD than placebo
injection. Moreover, patients in this dose group had a statistically
significant improvement in visual acuity at the 35-day timepoint when
compared to placebo. Also, the trial showed that patients receiving
microplasmin were significantly more likely not to require vitrectomy surgery
to resolve their underlying disease.
The results outlined in the article highlight that microplasmin could be
a potential breakthrough for the treatment of certain patients suffering from
vitreoretinal pathologic conditions related to vitreomacular adhesion.
Vitreomacular adhesion is thought to play a key role in numerous back of the
eye conditions such as macular hole formation, and some forms of macular
edema. Vitreomacular adhesion is also associated with much poorer prognosis
in certain major eye conditions, including diabetic retinopathy and
Age-Related Macular Degeneration (AMD).
ThromboGenics is now conducting an extensive Phase III program with
microplasmin, referred to as MIVI-TRUST (Microplasmin IntraVitreous Injection
- Traction Release without Surgical Treatment), for the non-surgical
resolution of focal vitreomacular adhesion. The patient enrollment for the
two Phase III trials was completed in 2009 ahead of schedule. The first
results from this Phase III program are due in Q2 2010.
For a full discussion of the results from the Phase II trial (MIVI III),
please refer to the Ophthalmology article. Further information is also
included in the ThromboGenics press release dated 30 June, 2008 (see
Steve Pakola, MD, Chief Medical Officer of ThromboGenics and co-author of
the Ophthalmology paper, commented, "We are very pleased to have had these
results with microplasmin published in such a prestigious journal. The Phase
II trial data discussed in the paper demonstrate the exciting potential of
microplasmin in treating a range of important back of the eye diseases. We
very much look forward to announcing the first results from our Phase III
program with microplasmin by mid 2010."
SOURCE ThromboGenics NV