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Each ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering sustained sub microgram levels of fluocinolone acetonide (FAc). ILUVIEN is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25 Gucci Belt Double G Snake
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Additionally, the committee noted that, based on the PAS, the cost effectiveness threshold has been met for a subgroup of chronic DME patients who are pseudophakic, or have already undergone cataract replacement surgery.
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"We are pleased with the Appraisal Committee's recommendation to provide access to ILUVIEN for pseudophakic DME patients, which is an important step in making this treatment available. We are optimistic that this ACD will lead to a change Gucci Belt Picture in the final published guidance. Gucci Belts Images
"I am delighted that the Appraisal Committee has reconsidered the NICE guidance on ILUVIEN," said Mr. Winfried Amoaku, an associate professor and consultant ophthalmologist with Nottingham University Hospitals NHS Trust. "Chronic DME patients who are pseudophakic are now one step closer to receiving this crucial sight saving treatment from the National Health Service. We cannot put a price on eyesight. Anything we can do to treat or prevent vision loss is essential. I welcome the Appraisal Committee's recommendation on the pseudophakic subgroup. It is hoped that NICE will update its recommendation in the fullness of time to allow access for a wider population of people with chronic DME."
John Mills, ICR
All forward looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward looking statements Alimera makes or that are made on its behalf. These forward looking statements speak only as of the date of this press release (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward looking statements, whether as a result of new information, future events or otherwise.
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ATLANTA, June 14, 2013 /PRNewswire/ Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the Appraisal Committee of the United Kingdom's National Institute for Health and Care Excellence (NICE) has issued a positive Appraisal Consultation Document (ACD) on ILUVIEN for the treatment of pseudophakic patients with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. The ACD recommends a change to the published guidance issued by NICE on January 29, 2013, and takes into consideration a simple patient access scheme (PAS) that was submitted by Alimera for rapid review.
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Alimera Sciences, Inc., based in Alpharetta, Georgia, is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Presently Alimera is focused on diseases affecting the back of the eye, or retina. Such forward looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward looking statements. In addition to the risks described above and in Alimera's Annual Report on Form 10 K, Quarterly Reports on Form 10 Q, Current Reports on Form 8 K and other filings with the SEC, other unknown or unpredictable factors also could affect Alimera's results. There can be no assurance that the actual results or developments anticipated by Alimera will be realized or, even if substantially realized, that they Gucci Belt Pink
will have the expected consequences to, or effects on, Alimera. Therefore, no assurance can be given that the outcomes stated in such forward looking statements and estimates will be achieved.
gauge needle, which allows for a self sealing wound. The MAA included data from two Phase 3 pivotal clinical trials (collectively known as the FAME Study) for ILUVIEN conducted by Alimera. The trials involved 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of ILUVIEN for the treatment of DME. At the end of the DCP, a consensus was reached by the RMS and the other six countries that the MAA for ILUVIEN was approvable. To date, six of the seven countries, Austria, the United Kingdom, Portugal, France, Spain and Germany have granted national licenses for ILUVIEN. ILUVIEN has not been approved by the United States Food and Drug Administration.
The NICE Appraisal Committee has reconfirmed ILUVIEN's clinical effectiveness in the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In the ACD, the Appraisal Committee reiterated "that the technology had been shown to meet a clinical need in people whose disease is unresponsive to available therapies."
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