Alimera Sciences Inc (ALIM)

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1:01AM Alimera Sciences' ILUVIEN receives final draft guidance from U.K.'s NICE; not recommended for the treatment of chronic diabetic macular edema considered insufficiently responsive to available therapies (ALIM) 2.32 : Co announces that the United Kingdom's National Institute for Health and Clinical Excellence has issued final draft guidance indicating that ILUVIEN is not recommended for the treatment of chronic diabetic macular edema considered insufficiently responsive to available therapies. While the Appraisal Committee acknowledged the clinical effectiveness of ILUVIEN in the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies, it noted that cost-effectiveness thresholds for the product have not yet been met. In response to the final draft guidance, Alimera is now developing a Patient Access Scheme to address the Appraisal Committee's cost concerns that pose a barrier to access for people in the United Kingdom with chronic DME who might benefit from ILUVIEN. The goal of the PAS will be to determine the appropriate pricing for ILUVIEN in order to ensure that treatment decisions are based on patient need, rather than cost. ALIM is a pSivida (PSDV) licensee and plans to institute pivotal Phase III clinical trials for the treatment of posterior uveitis with the same micro-insert as ILUVIEN for DME. An investigator-sponsored clinical trial is ongoing for an injectable, bioerodible micro-insert to treat glaucoma and ocular hypertension. pSivida's two FDA-approved products, Retisert and Vitrasert, are implants that provide long-term, sustained drug delivery to treat two other chronic diseases of the retina