ANI Pharmaceuticals Announces Publication of NEW DAY Clinical Trial Results in Ophthalmology

Rhea-AI Summary

ANI Pharmaceuticals (Nasdaq: ANIP) announced publication (April 7, 2026) of the NEW DAY randomized Phase 4 trial of ILUVIEN (fluocinolone acetonide 0.19 mg) in Ophthalmology. The report presents safety and efficacy data for ILUVIEN as a baseline therapy for diabetic macular edema in previously steroid-treated patients.

The publication includes key safety findings: intraocular pressure elevations and high cataract incidence versus sham, and notes ILUVIEN's approved indication for DME in selected patients.

Positive

• Peer-reviewed publication in Ophthalmology (April 7, 2026)
• Phase 4 randomized data support ILUVIEN use as baseline therapy
• ILUVIEN indicated for DME after prior corticosteroid without IOP rise

Negative

• IOP ≥10 mm Hg in 34% of ILUVIEN patients versus 10% sham
• IOP ≥30 mm Hg in 20% of ILUVIEN patients versus 4% sham
• Cataract incidence 82% in ILUVIEN group versus 50% sham
• 5% of ILUVIEN patients required surgical intervention for elevated IOP

News Market Reaction – ANIP

+2.94%

18 alerts

+2.94% Session close to close

$1.82B Market Cap

0.6x Rel. Volume

In the Apr 7 session, ANIP gained 2.94%, reflecting a moderate positive market reaction. Our momentum scanner triggered 18 alerts that day, indicating notable trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights peer-reviewed publication of NEW DAY Phase 4 results for ILUVIEN in dia...

Analysis

This announcement highlights peer-reviewed publication of NEW DAY Phase 4 results for ILUVIEN in diabetic macular edema, reinforcing ANI’s focus on generating robust clinical evidence. Prior NEW DAY disclosures and Cortrophin Gel data in 2025 show a consistent cadence of trial and preclinical updates. Investors may monitor how this publication influences ILUVIEN’s clinical adoption, safety perceptions, and the company’s broader ophthalmology and rare-disease positioning over time.

Key Figures

ILUVIEN dose: 0.19 mg Cataract incidence (ILUVIEN): 82% Myodesopsia incidence: 21% +5 more

8 metrics

ILUVIEN dose 0.19 mg Fluocinolone acetonide intravitreal implant strength in NEW DAY trial

Cataract incidence (ILUVIEN) 82% Ocular adverse reaction rate in 3-year DME clinical trials

Myodesopsia incidence 21% Ocular adverse reaction rate in DME trials after ILUVIEN

IOP ≥10 mm Hg increase 34% vs 10% Proportion of ILUVIEN vs sham patients with ≥10 mm Hg IOP rise

IOP ≥30 mm Hg 20% vs 4% ILUVIEN vs sham patients with IOP ≥30 mm Hg

IOP-lowering meds use 38% vs 14% Patients treated with IOP-lowering drugs after ILUVIEN vs sham

Cataract surgery rate 80% vs 27% Phakic eyes undergoing cataract surgery, ILUVIEN vs sham

Median cataract onset 12 vs 19 months Median time to cataract adverse event, ILUVIEN vs sham

Previous Clinical trial Reports

4 past events · Latest: Oct 16 (Positive)

Same Type Pattern 4 events

Date	Event	Sentiment	24h Move	Catalyst
Oct 16	NEW DAY data presentation	Positive	+2.0%	NEW DAY ILUVIEN results highlighted in late-breaking AAO 2025 oral session.
Jul 23	NEW DAY topline results	Neutral	+0.8%	NEW DAY trial missed primary endpoint but showed favorable secondary and post-hoc outcomes.
Jun 12	Preclinical arthritis data	Positive	-1.1%	Preclinical Cortrophin Gel data showed reduced joint swelling and cytokine response in mice.
May 05	Preclinical uveitis data	Positive	-0.5%	Cortrophin Gel preclinical EAU model data demonstrated dose-dependent suppression of inflammation.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical and trial-related updates have produced mixed reactions, with two prior events trading higher and two selling off despite generally positive or supportive data.

Recent Company History

Recent clinical news for ANIP has centered on ILUVIEN’s NEW DAY trial and Cortrophin Gel research. On Jul 23, 2025, NEW DAY topline results showed a missed primary endpoint but positive secondary and post-hoc findings. Subsequent NEW DAY dissemination on Oct 16, 2025 and preclinical Cortrophin data on May 5 and Jun 12, 2025 highlighted mechanistic and efficacy signals. Today’s publication in a leading journal continues this pattern of expanding evidence and visibility for the ophthalmology and rare-disease franchises.

Key Terms

diabetic macular edema, intravitreal, intraocular pressure, endophthalmitis, +4 more

8 terms

diabetic macular edema medical

"for use in appropriate patients with diabetic macular edema in Ophthalmology"

Diabetic macular edema is an eye condition in which fluid leaks into and swells the macula, the part of the retina used for sharp, central vision, often as a complication of diabetes. For investors it matters because it drives demand for medicines, medical devices and eye-care services, influences clinical trial and regulatory outcomes, and can affect healthcare costs and revenue forecasts—think of the macula as the camera’s central lens that becomes blurred when it soaks up excess fluid.

intravitreal medical

"fluocinolone acetonide intravitreal implant), 0.19 mg (ILUVIEN)"

An intravitreal treatment is one given by injecting medicine directly into the gel-like center of the eye, delivering drugs straight to the site of retinal disease rather than through pills or eye drops. Investors care because this delivery method affects development costs, regulatory review, clinical risk, manufacturing and distribution complexity, and reimbursement — all factors that influence a therapy’s commercial potential.

intraocular pressure medical

"did not have a clinically significant rise in intraocular pressure"

Intraocular pressure is the fluid pressure inside the eye, similar to the air pressure in a tire or the tension in a water balloon that helps the eye keep its shape. It matters to investors because sustained high pressure can lead to glaucoma and vision loss, driving demand for drugs, surgical devices, diagnostics and related regulatory approvals and reimbursements, which directly affect company revenues and risk profiles.

endophthalmitis medical

"Intravitreal injections, including those with ILUVIEN, have been associated with endophthalmitis"

A severe infection or intense inflammation that occurs inside the eye and can rapidly damage structures needed for vision. Think of it like an internal house fire that can destroy delicate wiring — it may follow surgery, injections, injury, or spread from elsewhere in the body and can lead to partial or total vision loss if not treated quickly. For investors it matters because outbreaks or cases can prompt regulatory actions, product recalls, liability claims, clinical trial delays, and reputational harm that affect a company’s finances and future prospects.

posterior subcapsular cataract medical

"The use of corticosteroids may result in posterior subcapsular cataract formation"

A posterior subcapsular cataract is a cloudy spot that forms at the back surface of the eye’s natural lens, just beneath its thin outer layer, and can cause glare, halos, and difficulty reading or seeing in bright light. Like a smudge on the back of a camera lens, it can progress and reduce vision; for investors it affects demand for treatments, surgical devices, replacement lenses and related diagnostics, influencing market size and company revenues.

slit lamp microscopy medical

"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"

A slit lamp microscope is a specialized eye exam instrument that shines a narrow, bright beam of light into the eye while a clinician looks through a magnifying lens to inspect the front and back structures of the eye, like using a flashlight and magnifying glass to examine a watch. For investors, results from slit lamp exams matter because they provide objective, clinically accepted evidence about whether an eye drug, implant or surgical device is safe and effective, influencing regulatory approval, market adoption and liability risk.

Phase 4 medical

"Results from the Randomized Phase 4 NEW DAY Study"

Phase 4 is the stage after a drug or vaccine has been approved and is sold to the public, where regulators and companies keep watching how it performs in the real world to detect rare side effects, long‑term effects, or differences in effectiveness across different groups. Think of it as ongoing quality control for a product already on shelves; results can prompt label changes, safety warnings, sales impacts or recalls, all of which matter to investors evaluating risk and future revenue.

cup to disc ratios medical

"ILUVIEN is contraindicated in patients with glaucoma who have cup to disc ratios of greater than 0.8"

Cup-to-disc ratio is a measurement used in eye exams that compares the size of the hollowed center of the optic nerve head (the “cup”) to the full circular area around it (the “disc”), often expressed as a fraction or decimal. Think of it like comparing the hole in a donut to the whole donut: a larger hole can signal damage to the nerve from conditions such as glaucoma. For investors, changes in this ratio are a common clinical sign used to evaluate the effectiveness of eye drugs or devices, influence regulatory decisions, and affect market potential for ophthalmology treatments.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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PRINCETON, N.J., April 07, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced publication of the results from the NEW DAY clinical trial involving ILUVIEN^® (fluocinolone acetonide intravitreal implant), 0.19 mg (ILUVIEN) for use in appropriate patients with diabetic macular edema in Ophthalmology, the journal of the American Academy of Ophthalmology. The company previously announced results from the NEW DAY trial in July 2025. 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.

“We are proud that the results from the NEW DAY clinical trial have been published in Ophthalmology, a leading, globally respected peer-reviewed journal,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI. “This publication represents our team’s continued commitment to generating clinical data for patients living with DME and for the overall retina community.”

The published research article is currently available on the Ophthalmology website titled: “Fluocinolone Acetonide Implant as a Baseline Therapy for Diabetic Macular Edema: Results from the Randomized Phase 4 NEW DAY Study.”

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
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 relate to 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, statements regarding the Company’s strategy; its plans with respect to the commercialization and potential sales of the Company’s products, including current and planned product launches and any additional product launches from the Company’s generic pipeline; expansion plans for the Rare Disease business, including with respect to the planned expansion of the Company’s sales force for acute gouty arthritis; anticipated growth opportunities for ILUVIEN; anticipated R&D developments and clinical trial advances; and 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 the Company’s approved products, including ILUVIEN, to achieve commercialization at levels of market acceptance that will allow the Company to maintain profitability; delays and disruptions in the production of the Company’s approved products; increased costs and potential loss of revenues if the Company needs to change suppliers due to the limited number of suppliers for its raw materials, active pharmaceutical ingredients, expedients, and other materials; delays and disruptions in the production of the Company’s approved products as a result of its reliance on single source third party contract manufacturing supply for certain of its key products, including ILUVIEN; delays or failure to obtain or maintain approvals by the FDA of the Company’s products; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies; risks that the Company 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 the Company’s products from both domestic and overseas sources due to supply chain disruptions or for any other reason; the ability of the Company’s manufacturing partners to meet its product demands and timelines; the level of competition the Company faces and the legal, regulatory and/or legislative strategies employed by its competitors to prevent or delay competition from generic alternatives to branded products; the Company’s ability to protect its intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the Company’s ability, and that of its suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; ; and general business and economic conditions, such as inflationary pressures, geopolitical conditions.

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

Media Relations:
Argot Partners
T: 212-600-1494
E: ani@argotpartners.com

FAQ

What did ANI Pharmaceuticals (ANIP) publish about the NEW DAY trial on April 7, 2026?

ANI published randomized Phase 4 NEW DAY trial results on ILUVIEN for diabetic macular edema. According to the company, the paper in Ophthalmology reports safety and efficacy data supporting ILUVIEN as a baseline therapy in previously steroid-treated patients without prior IOP issues.

How common were intraocular pressure increases with ILUVIEN in the NEW DAY trial (ANIP)?

Intraocular pressure increases were frequent with ILUVIEN in NEW DAY. According to the company, 34% had ≥10 mm Hg IOP rise and 20% had ≥30 mm Hg versus 10% and 4% in sham respectively.

What cataract outcomes did the NEW DAY publication report for ILUVIEN (ANIP)?

Cataract incidence was substantially higher with ILUVIEN versus sham. According to the company, 82% of ILUVIEN patients developed cataracts versus 50% of sham, with 80% of ILUVIEN subjects undergoing cataract surgery.

Does the NEW DAY publication change ILUVIEN's approved use for diabetic macular edema (ANIP)?

The publication documents clinical data but does not itself change approval status. According to the company, ILUVIEN remains indicated for DME in patients previously treated with corticosteroids who did not have clinically significant IOP rises.

What safety monitoring does ANI recommend for patients receiving ILUVIEN after NEW DAY publication?

Close ophthalmic monitoring for IOP and cataract development is advised after ILUVIEN. According to the company, patients should have routine intraocular pressure checks and follow-up due to observed IOP elevations and high cataract rates.