Alimera Sciences expects top-lined data from NEW DAY study in 1Q25

Alimera’s overenrolled NEW DAY Study evaluating ILUVIEN’s utility as baseline therapy head-to-head versus the leading anti-VEGF in the treatment of diabetic macular edema has completed enrollment with 306 patients and remains on track with top-line data anticipated in the first quarter of 2025. Alimera is actively enrolling patients in the SYNCHRONICITY Study, a prospective, open-label clinical study evaluating the safety and efficacy of YUTIQ for the treatment of chronic, non-infectious uveitis affecting the posterior segment and related intraocular inflammation. This is a two-year follow-up study with an interim top-line six-month efficacy readout anticipated in the third quarter of 2024. Alimera has completed enrollment in the CALM Study with 240 eyes. The CALM Study is a registry study conducted in collaboration with the Cleveland Clinic collecting real world data to better understand the variety of conditions treated with YUTIQ for non-infectious uveitis affecting the posterior segment. Alimera plans to present efficacy outcome data on individual and combined patient cohorts during medical conferences in 2024. Alimera is working with the Jaeb Center for Health Research Foundation Inc. acting on behalf of the DRCR Retina Network to provide ILUVIEN and support Protocol AL. Protocol AL is a randomized clinical trial evaluating intravitreal Faricimab injections or Fluocinolone Acetonide intravitreal implants versus observation in the prevention of visual acuity loss due to radiation retinopathy following plaque brachytherapy.