European regulatory authorities have backed Novartis’ licence application for its new eye drug Jetrea (ocriplasmin).
The positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) puts Jetrea on course to become the first approved drug treatment for vitreomacular traction (VMT) and macular hole, a sight-threatening condition.
At present the age-related progressive condition, which affects an estimated 250,000 to 300,000 patients in Europe, is tackled by ‘observation’ or ‘watchful waiting’ until a patient becomes eligible for surgical intervention.
This usually only comes at a very late stage of the disease and is not a suitable option for many patients, in whom damage to the retina may have already occurred.
Novartis’ Alcon division acquired commercialisation rights to Jetrea from its discoverer, the Belgium-based biopharmaceutical company ThromboGenics, in a €375m deal last March.
Sabri Markabi, senior vice president, research and development at Alcon, said: “We are excited to bring this innovative treatment to patients in Europe who live with VMT and macular hole and for whom there has been limited prospect of treatment.
“This demonstrates Alcon’s steadfast commitment to addressing unmet patient needs in the field of eye care. Europe will be the first region outside the US where we expect Jetrea to be approved and our goal is to make this treatment accessible to many more patients around the world.”
Jetrea is a recombinant form of human protein (plasmin) that is administered through a one-time, single intravitreal injection.
Its CHMP recommendation was based on two phase III trials that both met their primary endpoint, showing the single Jetrea injection successfully resolved VMT and macular hole compared to placebo.
After 28 days, 26.5 per cent of Jetrea-treated patients achieved resolution of VMT (versus 10.1 per cent with placebo), and 72 per cent of the Jetrea patients who achieved resolution by day 28, did so within seven days.
The treatment was launched in the US last week, having been approved in October, and its recommendation from the CHMP should translate into full European approval within the next three months.