European regulators have expanded the use of Allergan’s eye therapy Ozurdex to treat diabetic macular oedema in certain circumstances.
The European Commission has green-lighted its use in patients with the condition who also have an artificial lens implant (pseudophakic) or who don’t respond to or are unsuitable for, therapy with non-corticosteroids.
DME is a common complication with diabetes and the leading cause of sight loss in patients with the disease. Its incidence is expected to rise with the growing prevalence of diabetes in Europe, which is forecast to increase from 8.5% in 2013 to 10.3% in 2035, highlighting the urgent need for new treatment options.
Ozurdex is a sustained-release biodegradable steroid implant that contains the potent corticosteroid dexamethasone, which is slowly released to control swelling, tackle inflammation and improve vision.
In Europe it is already on the market to treat macular oedema in patients with retinal vein occlusion and for inflammation of the posterior segment of the eye characterised as non-infectious uveitis.
Meanwhile, as the bitter takeover battle between Allergan and Valeant/Pershing Square rages on, a shareholder lawsuit dating back to 2010 alleging that the firm improperly marketed its anti-wrinkle treatment Botox for ‘off-label’ uses has reportedly been revived by a US appeals court.
Overturning a previous decision, the court ruled that the plaintiffs do indeed have enough information to proceed with their case, according to Reuters, marking a further blow to Allergan, which is desperately trying to hold onto its independence.