Tag:

Iluvien

Latest Headlines

Latest Headlines

Alimera, pSivida skyrocket as they give the thrice-rejected Iluvien another go

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.

Alimera, pSivida plummet after FDA rejects eye drug yet again

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 taps Quintiles to commercialize Iluvien

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.

Iluvien stumbles on rocky road to market in U.K.

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NICE has not recommended pSivida's fluocinolone insert for the treatment of vision loss in diabetes in its final draft guidance.

Alimera, pSivida ride ups and downs with Iluvien

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.

UPDATED: Alimera $40M sale funds Iluvien's march across Europe

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.

pSivida eyes FDA approval with trial for Durasert-delivered drug

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.

pSivida gets U.K. nod for behind-the-eye treatment

More good news for pSivida: The company's behind-the-eye macular edema treatment, Iluvien, picked up another approval.

Alimera shares leap on FDA filing for lead program 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

Alimera slashes IPO price while Codexis delivers at low end

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