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Lucentis claims speedy FDA review for myopia complication

Roche’s drug achieved superior visual acuity gains compared to standard treatment in trials

RocheThe US FDA has said it will use its six-month review process for Roche's Lucentis as a treatment for choroidal neovascularization in patients with severe near-sightedness (myopia).

CNV is the most common cause of visual impairment and blindness in highly myopic patients younger than 50 years of age and at the moment the only approved treatment in the US is photodynamic therapy with verteporfin.

The filing is based on data from the phase III RADIANCE study, which showed that treatment with VEGF inhibitor Lucentis (ranibizumab) achieved superior visual acuity gains in people with the eye disease compared to verteporfin.

"Currently, the FDA-approved treatment option for myopic CNV only stabilises vision for patients temporarily," said John Wells III, chairman of the department of ophthalmology at the Palmetto Health-USC Medical group in Columbia, South Carolina.

"If approved, Lucentis could be an important tool in helping these patients improve vision," he added.

Estimates are that myopic CNV occurs in approximately 0.04% to 0.05% of the general population, which would equate to around 10 million people in the US alone.

Approval in a sizeable new patient population would help Roche recapture ground lost to Bayer and Regeneron's rival VEGF inhibitor Eylea (aflibercept), which has been growing at a phenomenal pace with sales expected to exceed $5bn this year.

Sales of Roche's drug slipped 12% to CHF 704m ($711m) in the first half of the year, while and European marketing partner Novartis said its revenues from the drug fell 14% to $927m.

Eylea is not yet approved for mCNV in the US, although Bayer has a green light for this use in Europe and so is already competing head-to-head with Novartis in the EU myopic CNV market, adding to their rivalry in other indications such as wet age-related macular degeneration and diabetic macular oedema.

Article by
Phil Taylor

12th October 2016

From: Regulatory

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