Phase III data for eye drug
17.08.2012 - Belgian biopharmaceutical company ThromboGenics N.V. published encouraging data from two Phase III studies with its eye treatment experimental drug Ocriplasmin.
The studies published in New England Journal of Medicine (NEJM) including in total 652 patients found that the recombinant protein significantly resolved vitreomacular traction and closed macular holes compared to placebo in patients with vitreomacular adhesion (VMA). A health care practitioner, who treated patients in one of the studies said ocriplasmin could help a significant number of patients at an earlier point in their disease and improve their vision much more than surgery, which is the current standard of care.
"Results from the phase III programme with ocriplasmin are significant as they demonstrate the potential for using an enzymatic approach to resolve vitreomacular adhesion. This represents a real advance for patients living with vitreomacular adhesion who currently only have the option of surgery at a later stage of the disease," said Peter Stalmans, Department of Ophthalmology, University Hospitals, Leuven, Belgium. "The majority of patients who achieved resolution of their vitreomacular adhesion after a single intravitreal injection of ocriplasmin showed this positive outcome within the first seven days."
Ocriplasmin is a recombinant, truncated form of human plasmin that works by dissolving the proteins that link the vitreous to the macula. If approved, the drug, couldbecome the first pharmaceutical treatment for vitreomacular adhesion (VMA). Currently vitrectomy, or surgical removal of the vitreous from the eyeball, is the only available treatment for VMA. In patients with VMA, the vitreous adheres in an abnormally strong way to the retina, which can lead to traction on the retina, causing symptoms including impaired vision. Further unresolved traction may lead to the development of macular holes and central blindness.Thrombogenics developed the biologic and plans to market ocriplasmin on its own in the US. In a deal worth up to €300m in milestone payments and royalties Swiss drug maker Novartis’ subsidiary Alcon paid €75m up front in March to license the ex-US rights to the drug, which is currently under review by FDA and EMA.