Iluvien Gains Ground

Iluvien Approved in Europe

Iluvien continues to make progress outside the US for treatment of macular edema due to diabetic retinopathy. Iluvien, a sustained release drug delivery system from Alimera Sciences, is a proprietary intraocular injection for the treatment of diabetic macular edema.  Iluvien releases a steroid for up to 36 months and may be a significant treatment for the most common … [Read more...]

Iluvien Marches Forward in Europe

Iluvien advances in the regulatory process for use in the treatment of diabetic macular edema in Europe. Similar to the FDA process, Alimera announced the "positive outcome of the Decentralized Procedure (DCP)" for use in Europe.  The European process now involves a national phase of the DCP where a panel of countries will need to recommend Iluvien for medical … [Read more...]

Still No Iluvien

FDA Denies Alimera Sciences' Iluvien for Treatment of Diabetic Macular Edema

  Alimera Sciences fails to get FDA approval for Iluvien.  Iluvien is a sustained release drug delivery system that releases a steroid into the eye for the treatment of diabetic macular edema.  Alimera received the denial late last week in a letter from the FDA. Implant Too Risky In short, the FDA still has concerns about the safety of the new drug.  Original … [Read more...]

Alimera Sciences Says Iluvien Effective at 3 Years

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Iluvien, a sustained release drug-delivery system for the treatment of diabetic macular edema, may be getting closer to possible FDA approval.  The parent company, Alimera Sciences has resubmitted additional safety and efficacy data as requested by the FDA last year.  The FDA requested that they be given data extending for a 3 year period instead of the 2 years in the new … [Read more...]

FDA Denies Iluvien

Iluvien Denied by FDA

The Food and Drug administration fails to approve Iluvien for the treatment of diabetic retinopathy and cites the need for more safety information in addition to concerns about the safety of the manufacturing process of Iluvien.   Alimera Sciences had hoped to gain approval by the end of December 2010, instead, it was told by the FDA that more information was … [Read more...]

Iluvien Gets Closer to FDA for Diabetic Retinopathy

Iluvien, an injectable drug delivery system for the treatment of diabetic retinopathy, gets closer to becoming FDA approved.  Alimera Sciences announced this week that the FDA has given the investigational device "Priority Review" status.  Priority Review status hastens the chances of full FDA endorsement from 10 months to 6 months. What is Iluvien? Iluvien is a … [Read more...]

Iluvien: New Drug for Diabetic Macular Edema

Iluvien™,  a new drug for the treatment of diabetic macular edema,  draws one step closer to FDA approval.  Alimera Sciences/pSivida announced that Iluvien showed favorable results in two Phase 3 clinical trials.  The company has announced they will file for a New Drug Application (NDA) based on the favorable results. Iluvien is a Sustained Release Drug Delivery … [Read more...]

2010: “Year of the…Drug Delivery System?”

2010 may be the year of drug delivery systems.  Icon Bioscience, Inc., (IBI) has announced their initiation of Phase 2 and Phase 3 clinical trials for an injectable sustained release system for the use in cataract surgery.  Their product, under the code name IBI-10090, will release anti-inflammatory drug for 2-3 weeks after cataract surgery.  It is hoped that this will … [Read more...]

Iluvien® For Diabetic Macular Edema Has Eyes on FDA

™Alimera Sciences' "Iluvien®" moves closer to FDA approval for the treatment of diabetic macular edema.  Iluvien is an extended release drug delivery system designed for direct intravitreal injection to the eye.  Iluvien will release a steroid, fluocinolone acetonide, for up to 36 months to treat retinal swelling.  The company has announced pivotal results in the ongoing … [Read more...]

SurModics’ Drug Delivery to Release Lucentis for Macular Degeneration

In a press release this week, Surmodics, Inc., announced its agreement with Roche and Genentech, manufactureres of Lucentis® (ranibizumab), to develop a sustained release drug delivery system for the treatment of wet macular degeneration. Surmodics has a drug delivery system based upon biodegradable microparticles that may potentially reduce the annual number injections … [Read more...]

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