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]

Core Viewpoint - Oculis Holding AG has completed enrollment in Phase 3 DIAMOND-1 and DIAMOND-2 trials for OCS-01 eye drops aimed at treating diabetic macular edema (DME), with pivotal data expected in Q2 2026, potentially leading to the first non-invasive topical treatment for DME [1][2][3] Company Overview - Oculis is a global biopharmaceutical company focused on innovative treatments for ophthalmic and neuro-ophthalmic diseases, with a pipeline that includes OCS-01 for DME, OCS-05 for acute optic neuritis, and OCS-02 for dry eye disease [12] Clinical Trials - The DIAMOND program consists of two Phase 3, double-masked, randomized trials evaluating the efficacy and safety of OCS-01 in over 800 patients, with a primary endpoint of change in best corrected visual acuity after 52 weeks [11][8] - Topline data from both trials is anticipated in the second quarter of 2026, followed by a New Drug Application (NDA) submission to the FDA [2][8] Product Details - OCS-01 is an OPTIREACH® formulation of high concentration dexamethasone eye drops, designed to provide a non-invasive treatment option for DME, contrasting with current invasive methods like intravitreal injections [7][9] - The product aims to improve drug solubility and increase residence time on the eye surface, facilitating treatment access in early disease stages [9] Market Need - DME is a leading cause of visual loss in diabetes, currently affecting approximately 37 million people globally, with projections to rise to 53 million by 2040, highlighting the urgent need for effective and less burdensome treatments [10]