Belgian biopharmaceutical company ThromboGenics N.V. (TBGNF) said Wednesday that eye treatment experimental drug Ocriplasmin showed improved vision when compared to placebo in elderly patients needing risky eye surgery to cure symptomatic vitreomacular adhesion, or VMA.
This data from two Phase III clinical trials was published in the New England Journal of Medicine today. The data shows that single intravitreal injection of ocriplasmin was superior to placebo in resolving vitreomacular traction or VMT, and closing macular holes in patients with Vitreomacular Adhesions.
Dr Patrik De Haes, CEO of ThromboGenics, said: "The publication of the data from our pivotal Phase III trials with ocriplasmin in this prestigious peer-reviewed journal highlights the potential of this novel pharmacological approach for the treatment of VMA and associated VMT."
Symptomatic VMA is a progressive, debilitating eye disease that may lead to visual distortion, loss in visual acuity and central blindness.
Both the studies met the primary endpoint of pharmacological resolution of VMA, and the secondary endpoints of nonsurgical closure of a macular hole, avoidance of vitrectomy or surgery, and improvement in vision.
The two multicenter, randomized, double-blind Phase III trials with ocriplasmin were conducted in the U.S. and Europe and involved 652 patients with VMA.
Leuven, Belgium-based ThromboGenics has already made regulatory filings for ocriplasmin in both the U.S. and Europe.
While retaining its exclusive rights to commercialize ocriplasmin in the U.S., ThromboGenics has in mid-March signed a strategic partnership with Swiss drug maker Novartis International AG's (NVS) eye care division Alcon Laboratories for exclusive commercialization of ocriplasmin outside the U.S.
Ocriplasmin is a strategic fit for Alcon and is anticipated to further enhance its portfolio of innovative treatments for the eye.
"With Alcon's extensive commercial capabilities, geographic footprint and strong relationships with retinal specialists and ophthalmologists, we are well positioned to bring what we believe is a truly innovative treatment option to patients suffering from VMT and macular holes in Europe and other countries outside the United States," Alcon Division Head Kevin Buehler said in a statement.
A US Food and Drug Administration or FDA, advisory panel recommend ocriplasmin for the treatment of symptomatic VMA in July, and a decision on approval is expected from the FDA in the second half of 2012, reportedly on October 17.
ThromboGenics is getting ready to make ocriplasmin available to patients in the U.S., if approved finally. Ocriplasmin is the potential first pharmacological treatment for symptomatic VMA, including macular hole. VMA affects around 500,000 people in the U.S. and Europe's five largest nations.
In Europe, ocriplasmin was accepted for regulatory review by the European Medicines Agency (EMA) in October 2011 as the first pharmacological treatment for symptomatic VMA, including macular hole.
The Marketing Authorization Application (MAA), for ocriplasmin has been accepted for review in Europe and in the U.S. the FDA has accepted the Biologics License Application (BLA) filing and granted it Priority Review.
TBGNF closed Wednesday's regular trading session at $31.90, up $0.65 or 2.08% on a volume of 665 shares, and NVS closed at $60.00, up $0.35 or 0.59% on a volume of 9.22 million shares.
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