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Novartis, ThromboGenics' eye drug Jetrea gets green light in EU

First drug specifically approved for vitreomacular adhesion

Novartis Jetrea approval

Novartis has bolstered its ophthalmology portfolio in the EU after winning approval for Jetrea, the first drug specifically cleared for the eye disorder vitreomacular adhesion (VMA).

The approval of Jetrea (ocriplasmin) by the European Commission prompts a €45m milestone payment to Belgian company ThromboGenics, which originally developed the drug and also stands to get another €45m on its launch by Novartis' Alcon eyecare subsidiary.

VMA is a progressive, age-related condition that can lead to compromised vision and eventually central blindness, and affects around 300,000 people in Europe. It is caused by adhesion of the jelly-like substance in the centre of the eyeball to the retina, causing a 'pulling' effect that distorts vision.

Over time the pulling can lead to the formation of holes in the central region of the retina (macula), leading to loss of vision.

Specifically, Jetrea has been approved for vitreomacular traction (VMT) or symptomatic VMA, including when the pulling is associated with macular hole of diameter less than or equal to 400 microns. The drug is delivered as a one-time intravitreal injection and dissolves protein fibres which cause the pull between vitreous and macula.

The availability of the drug is a major boon for VMA patients, who until now have only had surgery as a treatment option, according to ThromboGenics.

Two phase III trials of Jetrea published in the New England Journal of Medicine (NEJM) show that the drug resolved 27 per cent of VMAs within 28 days, compared to 10 per cent in the placebo group. By the end of a six-month follow-up period, 18 per cent of the Jetrea group needed surgery, compared to 27 per cent of the placebo group.

Jetrea was approved for symptomatic VMA last year in the US, where ThromboGenics has retained exclusive commercial rights, and was launched onto the market in January 2013. The Belgian company licensed ex-US rights to Alcon in March 2012 in a deal valued at up to €375m.

The launch is a transformative event for ThromboGenics, as Jetrea is its first commercial product and will provide a revenue stream both from its own commercial operations in the US and from Novartis in the form of royalties, estimated to be as high as 30 per cent of sales.

Analysts have suggested Jetrea sales could reach $500m in the US alone, with a similar-sized market ready to be tapped by Novartis outside the US.

18th March 2013

From: Sales

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