ANI Pharmaceuticals Announces NEW DAY Clinical Trial Results to be Presented in Late-Breaking Oral Presentation at the American Academy of Ophthalmology 2025 Meeting

Rhea-AI Summary

ANI Pharmaceuticals (Nasdaq: ANIP) announced that results from the NEW DAY clinical trial of ILUVIEN (fluocinolone acetonide 0.19 mg) for diabetic macular edema will be presented in a late-breaking oral session at the American Academy of Ophthalmology (AAO) 2025 Retina Subspecialty Day on October 17, 2025 at 4:39 pm ET.

The release reiterates that NEW DAY results were previously reported and will be further disseminated at multiple meetings; it also restates ILUVIEN's indication for DME in patients previously treated with corticosteroids who did not have a clinically significant intraocular pressure rise, and summarizes key safety data including intraocular pressure and cataract incidence from the trials.

Positive

• Late-breaking oral presentation at AAO on Oct 17, 2025
• NEW DAY data already presented at multiple medical meetings

Negative

• IOP ≥10 mm Hg in 34% of ILUVIEN patients vs 10% sham
• IOP ≥30 mm Hg in 20% of ILUVIEN patients vs 4% sham
• Cataract incidence 82% for ILUVIEN vs 50% sham
• 80% of ILUVIEN subjects underwent cataract surgery vs 27% sham

Insights

Clinical and Commercial Ophthalmology Analyst

Presentation of previously reported NEW DAY results at AAO 2025 increases medical visibility but adds no new efficacy data.

ANI advances dissemination of the NEW DAY trial for ILUVIEN by securing a late-breaking oral slot at the American Academy of Ophthalmology meeting on October 17, 2025; this raises clinician awareness and may strengthen prescribing confidence where the trial already supports use in post‑steroid responders. The company leverages high‑profile meeting exposure to reinforce clinical understanding and to support ongoing medical education efforts.

Key dependencies and risks include the fact that the results were previously reported, so this event mainly affects perception rather than new regulatory or commercial milestones. Safety data cited remain material: IOP elevations (>=10% mm Hg change in 34% of ILUVIEN patients versus 10% sham; >=30% in 20% versus 4%), surgical IOP intervention in 5% of treated patients, and cataract incidence of 82% in phakic ILUVIEN eyes. These figures will shape clinician adoption conversations.

Watch for the live presentation on October 17, 2025 at 4:39 pm ET and any new subgroup or safety analyses released alongside slides or a poster; absence of new primary endpoint data limits immediate regulatory or revenue impact. Short horizon: meeting‑level attention and potential changes in prescribing discourse over weeks; medium horizon: expect subsequent detailed analyses at ASRS, EURETINA, and other meetings to determine whether clinician uptake or labeling discussions shift materially.

Presentation at AAO 2025 part of ongoing NEW DAY data dissemination at medical meetings

PRINCETON, N.J., Oct. 16, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq: ANIP) 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
  
  

INDICATION
ILUVIEN is a corticosteroid indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

• ILUVIEN is contraindicated in patients with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases.
• ILUVIEN is contraindicated in patients with glaucoma who have cup to disc ratios of greater than 0.8.
• ILUVIEN is contraindicated in patients with known hypersensitivity to any components of this product.
  
  

WARNINGS AND PRECAUTIONS

• Intravitreal Injection-related Effects: Intravitreal injections, including those with ILUVIEN, have been associated with endophthalmitis, eye inflammation, increased or decreased intraocular pressure, and choroidal or retinal detachments. Patients should be monitored following the intravitreal injection. Patients may experience temporary blurred vision after injection of the implant.
• Intraocular Pressure (IOP) Increase: Prolonged use of corticosteroids may result in the development of glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be routinely monitored during the course of the treatment.
• Cataracts: The use of corticosteroids may result in posterior subcapsular cataract formation.
• Delayed Corneal Wound Healing: The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation.
• Corneal and Scleral Melting: Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of ophthalmic corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation of the globe.
• Bacterial Infections: Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. Acute purulent or parasitic infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated.
• Viral Infections: Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.
• Fungal Infections: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.
• Risk of Implant Migration: Patients in whom the posterior capsule of the lens is absent or has a tear are at risk of implant migration into the anterior chamber.
  
  

ADVERSE REACTIONS
Diabetic Macular Edema
Ocular adverse reactions reported by greater than or equal to 1% of patients in the two combined 3-year clinical trials following injection of ILUVIEN for diabetic macular edema include: cataract (82%), myodesopsia (21%), eye pain (15%), conjunctival hemorrhage (13%), posterior capsule opacification (9%), eye irritation (8%), vitreous detachment (7%), conjunctivitis (4%), corneal oedema (4%), foreign body sensation in eyes (3%), eye pruritus (3%), ocular hyperaemia (3%), optic atrophy (2%), ocular discomfort (2%), photophobia (2%), retinal exudates (2%), anterior chamber cell (2%), and eye discharge (2%). Non-ocular adverse reactions reported by greater than or equal to 5% of patients include: anemia (11%), headache (9%), renal failure (9%), and pneumonia (7%)

Increased Intraocular Pressure: IOP elevation greater than or equal to 10 mm Hg from baseline at any visit was seen in 34% of ILUVIEN patients versus 10% of sham patients. IOP elevation greater than or equal to 30 mm Hg was seen in 20% of ILUVIEN patients versus 4% of sham patients. 38% of the patients who received ILUVIEN were subsequently treated with IOP-lowering medications during the study versus 14% of sham patients. 5% of the patients who received ILUVIEN needed surgical intervention for elevated IOP versus 1% of sham patients

Cataracts and Cataract Surgery: The incidence of cataract development in patients who had a phakic study eye was higher in the ILUVIEN group (82%) compared with sham (50%). The median time of cataract being reported as an adverse event was approximately 12 months in the ILUVIEN group and 19 months in the sham group. Among these patients, 80% of ILUVIEN subjects versus 27% of sham-controlled subjects underwent cataract surgery, generally within the first 18 months (median month 15 for both ILUVIEN group and for sham) of the studies.

Please see full Prescribing Information.

About ANI Pharmaceuticals, Inc.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) 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.

Forward-Looking Statements
To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the commercialization and potential sales of the product and any additional product launches from the Company’s generic pipeline, 2025 guidance, other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” the negatives thereof, or other words of similar meaning, derivations of such words and the use of future dates.

Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to: the ability of our approved products, including Cortrophin Gel, ILUVIEN and YUTIQ, to achieve commercialization at levels of market acceptance that will continue to allow us to achieve continued profitability; our ability to complete or achieve any, or all of the intended benefits of acquisitions and investments, including the acquisition of Alimera, in a timely manner or at all; the limitation of our cash flow as a result of the indebtedness and liabilities incurred from the acquisition of Alimera; the risks that our acquisitions and investments, including the acquisition of Alimera, could disrupt our business and harm our financial position and operating results; delays and disruptions in production of our approved products, increased costs and potential loss of revenues if we need to change suppliers due to the limited number of suppliers for our raw materials, active pharmaceutical ingredients, expedients, and other materials; delays and disruptions in production of our approved products as a result of our reliance on single source third party contract manufacturing supply for certain of our key products, including Cortrophin Gel, ILUVIEN and YUTIQ; delays or failure in obtaining and maintaining approvals by the FDA of the products we sell; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies, and the focus of the current U.S. presidential administration, including among other things, drug recalls, regulatory approvals, facility inspections and potential enforcement actions; risks that we may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of our products from both domestic and overseas sources due to supply chain disruptions or for any other reason, including increased costs due to tariffs; the ability of our manufacturing partners to meet our product demands and timelines; the impact of changes or fluctuations in exchange rates; our ability to develop, license or acquire, and commercialize new products; our obligations in agreements under which we license, develop or commercialize rights to products or technology from third parties and our ability to maintain such licenses; the level of competition we face and the legal, regulatory and/or legislative strategies employed by our competitors to prevent or delay competition from generic alternatives to branded products; our ability to protect our intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the impact of any litigation to which we are, or may become, a party; our ability, and that of our suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; our ability to maintain the services of our key executives and other personnel; the potential impact of new U.S. tax legislation on our business, including the One Big Beautiful Bill Act; and general business and economic conditions, such as inflationary pressures, geopolitical conditions including but not limited to the conflict between Russia and the Ukraine, the conflict in the Middle East, conflicts related to the attacks on cargo ships in the Red Sea, and the effects and duration of outbreaks of public health emergencies, and other risks and uncertainties that are described in ANI’s Annual Report on Form 10-K, quarterly reports on Form 10-Q, and other periodic reports filed with the Securities and Exchange Commission.

More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, and other periodic reports, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Relations:
Courtney Mogerley, Argot Partners
T: 646-368-8014
E: ani@argotpartners.com

FAQ

When will ANI (ANIP) present NEW DAY results at AAO 2025?

The late-breaking oral presentation is scheduled for October 17, 2025 at 4:39 pm ET during Retina Subspecialty Day.

What safety outcomes from NEW DAY should ANIP investors note?

Key safety findings include IOP ≥10 mm Hg in 34% of ILUVIEN patients and 82% cataract incidence in ILUVIEN-treated eyes.

Does ILUVIEN have a labeled indication relevant to NEW DAY?

Yes. ILUVIEN is indicated for diabetic macular edema in patients previously treated with corticosteroids who did not have a clinically significant IOP rise.

How widely have NEW DAY results been disseminated before AAO 2025?

NEW DAY results were previously reported and presented at meetings including ASRS and EURETINA, with additional analyses planned.

What intraocular pressure interventions occurred in the NEW DAY trial?

38% of ILUVIEN patients received IOP-lowering medications and 5% required surgical intervention during the study.