Partners Alimera and pSivida have three times gone to the FDA with the eye drug Iluvien and three times walked away with little to show for it. But the fourth go-round will be different, the partners believe, and investors would seem to agree, sending the companies' shares skyward on renewed hopes for a 2014 approval.
The FDA has once more rejected Alimera Sciences and pSivida's drug-device combo for diabetic vision loss, roughly halving the companies' stock value and casting further doubt on a treatment plagued by years of failure
Alimera Sciences is facing an uphill battle getting its chronic diabetic macular edema drug on shelves in Europe, and now the company has recruited Quintiles to manage the European launch of Iluvien.
In a blow to Iluvien's route to the market, NICE has not recommended pSivida's fluocinolone insert for the treatment of vision loss in diabetes in its final draft guidance.
NICE (the U.K.'s National Institute for Health and Clinical Excellence) has released a draft recommendation that does not back the use of Alimera's Iluvien, a sustained-release intravitreal implant for the treatment of visual loss caused by chronic diabetic macular edema (DME), saying that it just would not be cost-effective. This is a draft appraisal, and NICE expects to issue its final guidance in November.
After a submission to 7 European countries in July 2010, Georgia-based Alimera Sciences has been granted approval in France for Iluvien, the sustained release intravitreal implant for the treatment of visual loss caused by chronic diabetic macular edema (DME) that cannot be treated by other means.
Drug delivery firm pSivida took another step toward expanding its back-of-the-eye drug delivery platform, launching a trial for a posterior uveitis treatment.
More good news for pSivida: The company's behind-the-eye macular edema treatment, Iluvien, picked up another approval.
Alpharetta, GA-based Alimera Sciences managed to buck a rough morning on Wall Street as its shares were buoyed by the announcement that the developer has submitted its lead therapy of diabetic
The biotech industry got a mixed read on investors' appetite for IPOs yesterday. The biotech Codexis launched its IPO at the low end of its price range on Wednesday, raising $78 million as it