Enforcement Report - Week of January 31, 2024
Novel Labs' Generic Fluocinolone Acetonide Receives Approval in US
Alimera Announces Submission of Marketing Authorization Application in Switzerland for ILUVIEN®
ATLANTA, Oct. 06, 2022 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (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, announced today that post-hoc analyses from the PALADIN Phase 4 Safety Study demonstrate that median treatment frequency in diabetic macular edema (DME) patients treated with the ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg was lower than from patients on other regimens. ILUVIEN provides DME patients with continuous therapy for up to 36 months. As part of the PALADIN phase 4 study, investigators sought to quantify the treatments required by eyes prior to ILUVIEN and after injection of ILUVIEN.
ATLANTA, Sept. 23, 2022 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (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 it has entered into an agreement with the Jaeb Center for Health Research Foundation Inc. (JCHR), acting on the behalf of the DRCR Retina Network to support and provide ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant for “A Randomized Clinical Trial Evaluating Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss due to Radiation Retinopathy (Protocol AL)”.
ATLANTA, Aug. 31, 2022 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (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 clinical data for ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19mg will be featured in more than 20 scientific abstracts during the EURETINA 2022 congress being held in Hamburg, Germany from September 1-4, 2022.
A study presented at the annual Association for Research in Vision and Ophthalmology (ARVO) Virtual Meeting showed no significant differences between dexamethasone intravitreal implant (ZURDEX) and fluocinolone acetonide intravitreal implant (ILUVIEN 0.19 mg) in terms of controlling non-infectious posterior uveitis (NIPU) inflammation
ATLANTA, Sept. 23, 2020 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmology treatments for the management of retinal diseases, announces that clinical data for ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19mg will be featured in over 20 papers and presentations during the EURETINA 2020 Virtual Congress, to be held on October 2-4, 2020.
 Alimera Sciences, Inc. (Nasdaq: ALIM) (Alimera), a global pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals for the treatment of retinal diseases, announces that it has enrolled the first patient in the company’s NEW DAY clinical trial, a randomized, controlled, multi-center study designed to generate prospective data for ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg as a baseline therapy in patients diagnosed with diabetic macular edema (DME).
VASCEPA showed significant reduction in coronary revascularization, including coronary stenting and cardiac bypass surgery, in prespecified and post hoc analyses of landmark REDUCE-IT study