Novartis announced that the New England Journal of Medicine (NEJM) published the results of two phase III studies of the investigational eye treatment ocriplasmin. The studies including 652 patients found that ocriplasmin, significantly resolved vitreomacular traction and closed macular holes compared to placebo in patients with vitreomacular adhesion (VMA).
The results of these phase III trials, which both met their primary endpoints, demonstrate the efficacy of ocriplasmin which, if approved, could be the first pharmaceutical therapy to treat patients with vitreomacular adhesion. The ocriplasmin phase III programme was conducted by Alcon’s partner ThromboGenics, NV.
Vitreomacular adhesion, including vitreomacular traction (VMT) and macular holes, is an age-related progressive, debilitating eye disease that may lead to visual distortion, loss in visual acuity and central blindness. More than 300,000 patients suffer from this disease in Europe alone.
“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. 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,” said Dr Peter Stalmans, Department of Ophthalmology, University Hospitals, Leuven, Belgium.
In patients with VMA, the vitreous (jelly-like substance in the centre of the eye that is surrounded by a membrane) adheres in an abnormally strong way to the retina (light-sensitive layer of tissue at the back of the eye), which can lead to traction (‘pulling’) on the retina, causing symptoms including impaired vision. Further unresolved traction may lead to the development of macular holes and central blindness. The only treatment option for progressed VMT and macular holes is a surgical procedure called vitrectomy (removal of the vitreous from the eyeball). In cases where VMT and macular holes are not severe enough to require surgery, the standard of care is “watchful waiting.”
Ocriplasmin, a recombinant, truncated form of human protein (plasmin), works by dissolving the proteins that link the vitreous to the macula (centre of the retina), relieving the traction and resulting in posterior detachment of the vitreous from the retina.
Alcon, a division of Novartis, acquired the commercialisation rights to ocriplasmin outside the US from the Belgian biopharmaceutical company ThromboGenics, who retains the rights to commercialise the drug in the US. As the global leader in eye care, Alcon is dedicated to bringing innovative eye treatments to patients with unmet medical needs.
“The data from these studies provide a basis for worldwide regulatory filings. With Alcon’s extensive commercial capabilities, geographic footprint and strong relationships with retinal specialists and ophthalmologists, we are well positioned to bring this innovative treatment to patients outside the US, once it is approved,” said Kevin Buehler, Division Head, Alcon.
Ocriplasmin is currently under review with the European Medicines Agency (EMA) and was accepted for review by the EMA in October 2011. In July 2012, the US Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee issued a positive recommendation supporting approval of ocriplasmin in the US.
EP News Bureau
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