Core Insights - ANI Pharmaceuticals, Inc. announced the presentation of results from the NEW DAY clinical trial of ILUVIEN® for diabetic macular edema at the American Academy of Ophthalmology 2025 Meeting [1][2] Group 1: Clinical Trial Results - The NEW DAY trial results will be presented in a late-breaking oral presentation titled "A Randomized, Active-Controlled Trial of Fluocinolone Acetonide 0.19mg Intravitreal Implant for Diabetic Macular Edema: The NEW DAY Study" [2] - The presentation is scheduled for October 17, 2025, at 4:39 pm ET during Retina Subspecialty Day 2025 [2] - Previous presentations of the NEW DAY results have occurred at various medical meetings earlier this year [3] Group 2: Product Information - ILUVIEN is indicated for the treatment of diabetic macular edema in patients previously treated with corticosteroids without a significant rise in intraocular pressure [3] - The product is a corticosteroid delivered via an intravitreal implant [1] Group 3: Company Overview - ANI Pharmaceuticals is focused on developing, manufacturing, and commercializing innovative therapeutics across various therapeutic areas, including ophthalmology [10] - The company aims for sustainable growth through its Rare Disease, Generics, and Brands business segments [10]

Core Insights - Iridex Corporation has announced the successful enrollment of the first patient in the DAME Trial, which aims to evaluate the efficacy, safety, cost-effectiveness, and patient acceptability of adding subthreshold MicroPulse treatments to anti-VEGF therapy for severe diabetic macular edema (DME) [1][2] Company Overview - Iridex Corporation is a leader in developing and marketing innovative laser-based medical systems for ophthalmology, including treatments for glaucoma and retinal diseases [7][8] - The company's proprietary MicroPulse technology minimizes tissue damage while delivering therapeutic benefits, making it a safe and effective treatment option [7] Trial Details - The DAME Trial is an independent, investigator-led study involving at least 20 clinical sites and 264 participants across the UK, focusing on patients with severe DME [2][5] - The trial aims to establish a new treatment pathway by assessing the addition of subthreshold MicroPulse laser therapy after anti-VEGF treatment, specifically when central retinal thickness (CRT) is below 400 μm [2][5] Expected Outcomes - The primary goal of the DAME Trial is to demonstrate equivalence in best-corrected visual acuity outcomes between the two treatment arms over a 24-month period [5] - Secondary outcomes will include quality of life, cost-effectiveness, treatment burden, and patient-reported experiences [5] Significance of the Trial - The DAME Trial could potentially transform the management of DME by reducing the frequency of anti-VEGF injections, thereby lowering associated risks, costs, and patient burden [3][4] - The trial builds on the success of the DIAMONDS study, which previously demonstrated the safety and effectiveness of subthreshold MicroPulse laser treatment for DME [6]