ANI Pharmaceuticals Announces NEW DAY Clinical Trial Results to be Presented in Late-Breaking Oral Presentation at the American Academy of Ophthalmology 2025 Meeting
October 16, 2025 – Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical – ANI Pharmaceuticals, American Academy of Ophthalmology 2025 Meeting, clinical trials, diabetic macular oedema, ophthalmology
Presentation at AAO 2025 part of ongoing NEW DAY data dissemination at medical meetings
16 October 2025 — New Jersey, US — ANI Pharmaceuticals, Inc today announced that results from the NEW DAY clinical trial of ILUVIEN (fluocinolone acetonide intravitreal implant), 0.19 mg (ILUVIEN) for use in appropriate patients with diabetic macular edema (DME) will be presented in a late-breaking oral presentation during Retina Subspecialty Day 2025, being held October 17-18, 2025 at the American Academy of Ophthalmology (AAO) 2025 Meeting. The results from the NEW DAY trial have been previously reported.
“We are excited that these results will be presented in a late-breaking oral presentation at AAO 2025, which is the largest meeting of ophthalmologists in the U.S.,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI. “AAO represents a meaningful opportunity to engage on these results with the eye care community.”
The oral presentation, titled “A Randomized, Active-Controlled Trial of Fluocinolone Acetonide 0.19mg Intravitreal Implant for Diabetic Macular Edema: The NEW DAY Study,” will be presented by Victor H. Gonzalez, MD, founder of the Gulf Coast Eye Institute in Rio Grande Valley region of Texas. The presentation will be part of Section IX: Late Breaking Developments, Part 1 of Retina Subspecialty Day 2025 on Friday, October 17, with Dr. Gonzalez’s presentation scheduled to take place at 4:39 pm ET.
The NEW DAY results were first reported earlier this year, with several presentations at medical meetings already completed. Additional analyses of the NEW DAY results are planned to be presented at upcoming medical meetings this year:
- ASRS: First presented by Michael A. Singer, MD, at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting
- EURETINA: Presented by Charles Wykoff, MD, at the EURETINA Innovation Spotlight (EIS) 2025 Meeting
- AAO: Scheduled to be presented by Dr. Gonzalez, during Retina Subspecialty Day 2025 at the American Academy of Ophthalmology 2025 Meeting
- FLORetina: Scheduled to be presented by Christopher Riemann, MD, at the FLORetina International Congress on OCT and OCT Angiography in Rome (ICOOR) 2025 Meeting
About ANI Pharmaceuticals, Inc.
ANI Pharmaceuticals, Inc is a diversified biopharmaceutical company committed to its mission of “Serving Patients, Improving Lives” by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing; and its Brands business. For more information, visit www.anipharmaceuticals.com.
