Novartis eye drug nears approval
pharmafile | January 21, 2013 | News story | Sales and Marketing | AMD, CHMP, Jetria, Novartis
Novartis’ eye drug Jetrea has been given a positive opinion by the CHMP, pushing it to the brink of approval.
If authorised by the European Commission it would be the first treatment for the sight-threatening condition vitreomacular traction (VMT), from which as many as 300,000 Europeans are estimated to suffer.
Jetrea (ocriplasmin) was approved last October in the US to treat symptomatic vitreomacular adhesion (VMA) and was launched this month by Belgian biopha company ThromboGenics, which has the rights to it there.
The drug would be marketed in the EU by Novartis’ Alcon division following a $500 million deal with ThromboGenics. The indication is for VMT, including when associated with a macular hole of up to 400 microns in diameter.
Analysts have suggested Jetrea could hit peak sales of $600 million, and this does not include additional indications currently being tested in diabetic retinopathy (DR), age-related macular degeneration (AMD) and stroke.
Current standard of care for VMT is ‘watchful waiting’ followed by late-stage surgery – a course of action which, Novartis insists, is associated with further visual impairment and even blindness.
Phase III trial data has shown Jetrea significantly resolved VMT, which is an age-related condition, and macular hole, compared to placebo.
At day 28, 26.5% of Jetrea-treated patients achieved resolution of VMT (versus 10.1% with placebo), and 72% of those did so within seven days.
The drug, a recombinant form of human protein (plasmin), is administered once as an intravitreal injection.
“Europe will be the first region outside the US where we expect Jetrea to be approved,” said Sabri Markabi, Alcon’s senior vice president, R&D.
The most common adverse events with Jetrea included vitreous floaters, photopsia, conjunctival hemorrhage, injection-related eye pain, blurred vision, reduced visual acuity and retinal edema.
Novartis’ other ophthalmic offerings include blockbuster eye drug Lucentis (ranibizumab), licensed to treat wet AMD, retinal vein occlusion and diabetic macular oedema.
Adam Hill
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