A mood of cautious optimism likely presides over Alimera Sciences, as the firm looks towards transformational US and European regulatory decisions on Iluvien, a novel corticosteroid-eluting intravitreal device with the potential to become the first approved therapy for diabetic macular oedema (DME).Given that Iluvien’s commercial potential – analysts have pencilled in sales close to $500m by 2016 - was the core offering to new investors that bought into Alimera’s IPO earlier this year, the stakes are certainly high. Licensed from pSivida, FDA approval would also be a breakthrough moment for the Australian company which is set to receive a $25m milestone and 20% profit share. The FDA’s decision is expected by the end of the year while a verdict in Europe should come in the first quarter of 2011, a region in which Alimera hopes to find a commercialisation partner.
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