European launch for Lucentis looks imminent

April 1, 2006

Novartis has announced the submission of Lucentis (ranibizumab) for European Union approval, for the treatment of wet age-related macular degeneration (AMD).

Novartis has announced the submission of Lucentis (ranibizumab) for European Union approval, for the treatment of wet age-related macular degeneration (AMD).

In addition to the year one results, preliminary two-year data from the MARINA (minimally classic/occult trial of Anti-VEGF antibody Ranibizumab in the treatment of neovascular AMD) Phase III trial have recently been released. The trial enrolled 716 patients in the US with minimally classic or occult wet AMD and randomized them at a ratio of 2:1 to receive intravitreal Lucentis or a sham injection. Lucentis patients were further randomized to receive either 0.3 mg or 0.5 mg doses once a month for two years.

The ANCHOR Phase III trial (Anti-VEGF antibody for the treatment of predominantly classic choroidal neovascularization in AMD) compared two different doses of Lucentis to verteporfin (Visudyne) photodynamic therapy (PDT) in patients with wet AMD. Visual acuity in approximately 95% of Lucentis patients was maintained or improved as opposed to just 64% of those treated with PDT. This trial is ongoing in Europe, the US and Australia.

Furthermore, enrolment began last year, in the US, for a Phase IIIb study of Lucentis for patients with all subtypes of new or recurrent active subfoveal wet AMD. The SAILOR trial (Safety assessment of intravitreal Lucentis for AMD) will evaluate the safety of two different doses (0.3 and 0.5 mg) of the agent.

In addition to Novartis' submission to the European Union, the US FDA has accepted a Biologics License Application for Lucentis from Genetech including the assurance of a six-month priority review, meaning the US regulatory body have until the end of June 2006 to take action on the filing.

Genetech holds the commercial rights for Lucentis in North America while Novartis has exclusive commercialization rights for the rest of the world.

FDA recalls salt solution

The FDA has recalled all brands and sizes of a balanced salt solution made by Cytosol Laboratories, due to the presence of elevated endotoxin levels in some lots.

More than 300 reports of injuries, including toxic anterior segment syndrome, have been reported by patients using the products, causing the FDA to request that the manufacturer take immediate action to recover all stock.

It is thought that approximately one million units of the balanced salt solution were distributed in the two years between December 2003 and December 2005 under the brand names AMO Endosol, Cytosol Ophthalmics and Akorn.

Hospitals, healthcare professionals and patients are advised to cease use of the product with immediate effect and return all unused quantities to the manufacturers.

Macugen safe at two years

Pfizer has announced that the ocular and systemic safety of Macugen (pegaptanib sodium injection), as a treatment for wet age-related macular degeneration (AMD), has been maintained over a two-year period.