NIU-PS can affect people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness and is a leading cause of working age blindness in many countries.
It is a diverse group of non-infectious uveitic inflammatory conditions that can affect the posterior segment of the eye. ILUVIEN is not approved for treatment of uveitis in the United States.Ībout Non-Infectious Uveitis Affecting the Posterior Segment (NIU-PS) in late 2019, Belgium in 2021 and Ireland, Spain, and Italy in 2022. The non-infectious uveitis affecting the posterior segment indication for ILUVIEN was launched in Germany and the U.K. The 17 European countries include the U.K., Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, Czechia, the Netherlands, and Luxembourg. In March 2019, ILUVIEN received approval in the 17 countries under the Mutual Recognition Procedure for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. In 17 European countries, ILUVIEN is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. ILUVIEN is approved in the U.S., Canada, Kuwait, Lebanon and the U.A.E. With its CONTINUOUS MICRODOSING™ technology, ILUVIEN is designed to release sub-microgram levels of fluocinolone acetonide, a corticosteroid, for 36 months, to reduce the recurrence of disease, enabling patients to maintain vision longer with fewer injections. The Company’s primary product ILUVIEN is a sustained release intravitreal implant injected into the back of the eye. The ILUVIEN sustained release intravitreal implant is indicated in Europe for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies and for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). “The positive assessment coming from SUKL and the recognition of this unmet need by the NHIF will help physicians in the Czech Republic prevent the relapse of recurrent non-infectious uveitis affecting the posterior segment.” “We are pleased to gain this reimbursement in the Czech Republic and thankful to our partner Medis for this achievement and for their upcoming launch,” said Rick Eiswirth, President and Chief Executive Officer of Alimera. After the National Health Insurance Fund (NHIF) agreed to the unmet need and budget impact, the State Institute for Drug Control (SUKL) in the Czech Republic issued a positive decision that ILUVIEN is reimbursed for the prevention of the relapse in adult patients with recurrent non-infectious uveitis affecting the posterior segment of the eye. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be invaluable to patients, physicians, and partners concerned with retinal health and maintaining better vision longer, announces that Alimera Sciences Europe Limited, its Ireland-based European subsidiary, has been granted reimbursement for ILUVIEN ® (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant for non-infectious uveitis, through its distribution partner, Medis Pharmaceutical Company. 01, 2022 (GLOBE NEWSWIRE) - Alimera Sciences, Inc. Partner Medis Pharmaceutical to launch ILUVIEN for non-infectious uveitis affecting the posterior segment indication this quarterĪTLANTA, Nov.
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