ANI Pharmaceuticals Announces Positive Phase 4 Open-Label, Single-Arm SYNCHRONICITY Clinical Trial Results Presented as Late Breaking Oral Presentation at the American Academy of Ophthalmology 2026 Annual Meeting
Visual acuity and retinal thickness improvements persisted through 24 months, alongside reported eye-pressure complications and cataract surgery.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
ANI Pharmaceuticals (ANIP) announced that its Phase 4 SYNCHRONICITY eye-implant trial met both primary endpoints with statistical significance at six months. The U.S. open-label, single-arm study evaluated fluocinolone acetonide intravitreal implant 0.18 mg in patients with chronic non-infectious inflammation affecting the back of the eye who had responded to steroid therapy.
Among 108 patients, mean best-corrected visual acuity improved by 3.6 letters and central retinal thickness decreased by 157.5 microns at six months. At 24 months, the respective changes were +5.5 letters and −171.2 microns; 79.6% of study eyes had no inflammation recurrence. Treatment-related adverse events occurred in 29% of patients, and 7.4% required laser or surgical intervention to lower eye pressure. Cataract surgery occurred in 14.8% of study eyes. Results were presented on October 9, 2026, at the American Academy of Ophthalmology meeting.
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Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
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Positive
- Major pointSix-month visual acuity endpoint met: mean gain of 3.6 letters in 108 patients (p=0.0077).
- Major pointSix-month central retinal thickness endpoint met: mean decrease of 157.5 microns in 108 patients (p<0.0001).
- Minor pointMonth-24 visual acuity showed a mean gain of 5.5 letters from baseline.
- Minor pointMonth-24 central retinal thickness showed a mean decrease of 171.2 microns from baseline.
- Minor pointInflammation did not recur in 79.6% of study eyes; recurrence affected 20.4%, with median recurrence time of 168 days.
2 minor points
- Minor pointMacular edema resolution increased early and remained generally stable, reaching 48.2% of study eyes at month 24.
- Minor pointVascular leakage decreased from 78.7% at baseline to 55.6% of study eyes at month 24.
Negative
- Minor pointTrial evidence comes from an open-label, single-arm study, without a comparison arm.
- Minor pointTreatment-related treatment-emergent adverse events affected 29% of patients, including ocular hypertension 6%, cataract 5%, reduced visual acuity 5%.
- Minor pointEye pressure reached ≥25 mmHg in 17.6% of patients and ≥35 mmHg in 4.6%.
- Minor pointEye-pressure-lowering medication was used by 32 patients (29.6%).
- Minor pointLaser or surgical eye-pressure-lowering intervention was required by 7.4% of patients.
- Minor pointCataract surgery was reported in 16 study eyes (14.8%).
Key Figures
- Study population
- 108 patients
- Intent-to-treat population
- BCVA change
- +3.6 ETDRS letters
- Month 6; p=0.0077
- CST change
- -157.5 microns
- Month 6; p<0.0001
- BCVA change
- +5.5 ETDRS letters
- Month 24
- CST change
- -171.2 microns
- Month 24
- No recurrence
- 79.6% (86 of 108 study eyes)
- Over the 24-month study period
- Treatment-related adverse events
- 29% (31 of 108 patients)
- Safety population
- IOP-lowering intervention
- 7.4% (8 of 108 patients)
- Required laser or surgical intervention
Previous Clinical trial Reports
-
Reported significant six-month co-primary improvements in BCVA and CST from the same trial.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
bcva medical
cst medical
etdrs medical
sd-oct medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Trial met both co-primary endpoints of mean change from baseline in BCVA letter score and mean change from baseline in CST with statistical significance1 at 6 months, and these changes were maintained at 24 months (a key secondary endpoint)
- The most common adverse events reported were consistent with prior trials of fluocinolone acetonide intravitreal implant 0.18 mg
- Study evaluated patients with chronic NIU-PS in the U.S.; most patients in the study were treated by retina specialists
PRINCETON, N.J., Oct. 12, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that both 6-month and 24-month data from SYNCHRONICITY, its Phase 4, open-label, single-arm clinical trial of Fluocinolone Acetonide Intravitreal Implant in patients with chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS) were presented in a late-breaking oral presentation during Uveitis Subspecialty Day 2026 on October 9, 2026 by Dr. David R.P. Almeida, MD, MBA, PhD, President and CEO of Erie Retina Research, and Principal Investigator in SYNCHRONICITY, at the American Academy of Ophthalmology (AAO) 2026 Meeting in New Orleans.
Co-primary Endpoints
The trial met both co-primary endpoints with statistical significance in the intent-to-treat (ITT) population (n=108) at 6 months: mean change from baseline in best corrected visual acuity (BCVA) letter score as measured by ETDRS and mean change from baseline in central subfield thickness (CST) as measured by SD-OCT.
- Mean Change from Baseline in BCVA Letter Score at Month 6: Patients in the ITT population had a mean change from baseline BCVA of +3.6 letters gained (p =0.0077) at 6 months (mean BCVA letter score of 62.5 at baseline compared to 65.8 at month 6).
- Mean Change from Baseline in CST at Month 6: Patients in the ITT population also had a mean change from baseline CST of -157.5 microns (p<0.0001) at 6 months (mean CST of 505.7 microns at baseline compared to 348.8 microns at month 6).
Select Secondary Endpoints
Secondary efficacy outcomes showed that functional and anatomic changes were generally maintained at month 24 in the ITT population.
Secondary efficacy outcomes at month 24 included:
- Mean Change from Baseline in BCVA Letter Score: At month 24, mean change from baseline in BCVA letter score in the study eye was +5.5 ETDRS letters in the ITT population.
- Mean Change from Baseline in CST: At month 24, mean change from baseline in CST was −171.2 microns in the ITT population.
- Time to Recurrence of Non-infectious Inflammation in the Study Eye: Recurrence was defined as an increase in CST of >100 microns or based on the investigator’s medical judgment. Over the 24-month study period, 86 of 108 study eyes (
79.6% ) experienced no recurrence of non-infectious inflammation. Among the 22 study eyes (20.4% ) that experienced recurrence, median time to recurrence was 168 days. - Proportion of Study Eyes with Resolution of Macular Edema: The proportion of study eyes with resolution of macular edema increased during the early treatment period and remained generally stable through Month 24 in the ITT population, with
48.2% (n= 52/108) of study eyes meeting the criteria for resolution at Month 24. Resolution of macular edema was defined as a central subfield thickness (CST) of <325 µm on Heidelberg SPECTRALIS or <315 µm on Zeiss CIRRUS. - Presence of Vascular Leakage: The proportion of study eyes with vascular leakage as measured by wide field fluorescein angiography decreased from
78.7% (n=85/108) at baseline to55.6% (n=60/108) at month 24 in the ITT population.
Safety
The most common adverse events seen in SYNCHRONICITY were consistent with prior trials of the fluocinolone acetonide intravitreal implant. In the safety population,
“The positive 6 and 24-month results from the SYNCHRONICITY trial in steroid-responsive patients further support the use of fluocinolone acetonide intravitreal implant in patients with chronic NIU-PS being treated by retina specialists,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI. “We are proud to present these data at AAO, which reflects our commitment to generating data to better inform retina specialists considering ILUVIEN for their appropriate chronic NIU-PS patients.”
“SYNCHRONICITY followed patients with chronic NIU-PS for two years after a single implant. CST and visual acuity were improved at month 6 and remained improved at month 24, with a safety profile consistent with prior trials. These data give retina specialists useful information for clinical decision-making in chronic NIU-PS,” said David R.P. Almeida, MD, MBA, PhD.
SYNCHRONICITY (NCT05322070) was a prospective, Phase 4, open-label, single-arm, two year follow-up study conducted in the U.S. to evaluate the inflammatory control associated with fluocinolone acetonide intravitreal implant, 0.18 mg, designed to deliver a continuous low-dose corticosteroid, for the treatment of chronic non-infectious posterior segment uveitis that has responded to previous steroid therapy. In the SYNCHRONICITY trial patients received fluocinolone acetonide intravitreal implant 0.18 mg as an intravitreal injection in the designated study eye and were followed for 24 months after treatment. Primary endpoints measured at 6 months were mean change from baseline in BCVA letter score in the study eye measured by ETDRS and mean change from baseline CST as measured by SD-OCT. Patients enrolled in the study had to have a diagnosis of active, recurrent, unilateral or bilateral NIU-PS with a duration of at least 3 months from initial diagnosis. The study population had a mean age of 64 years and the majority of patients were female (
About ILUVIEN (fluocinolone acetonide intravitreal implant)
ILUVIEN is an intravitreal implant designed to release the corticosteroid fluocinolone acetonide in the eye for up to 36 months. ILUVIEN was approved by the U.S. Food and Drug Administration (FDA) in 2014 for the treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. In 2025 FDA approved the consolidation of the labeling for two bioequivalent strengths of fluocinolone acetonide into one Prescribing Information for ILUVIEN, thereby expanding the ILUVIEN label to include an indication for the treatment of chronic NIU-PS.
IMPORTANT SAFETY INFORMATION FOR ILUVIEN
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. For patients with non-infectious uveitis affecting the posterior segment, hypotony has been observed within 24 hours of injection and has resolved within 2 weeks. 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
Increased Intraocular Pressure: IOP elevation greater than or equal to 10 mm Hg from baseline at any visit was seen in
Cataracts and Cataract Surgery: The incidence of cataract development in patients who had a phakic study eye was higher in the ILUVIEN group (
Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Ocular adverse reactions reported by greater than or equal to
Increased Intraocular Pressure: IOP elevation greater than or equal to 10 mm Hg from baseline at any visit was seen in
Please see full Prescribing Information for ILUVIEN.
About Chronic Non-Infectious Uveitis of the Posterior Segment:
Chronic non-infectious uveitis of the posterior segment (chronic NIU-PS) is a sight-threatening recurrent inflammatory condition affecting the back of the eye that typically manifests through symptoms such as appearance of floaters, reduced visual acuity, sensitivity to light (photophobia), blurred vision, and difficulty seeing color or in the dark.
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 https://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, statements regarding the Company’s strategy; its expectations regarding its future operations, financial position or revenues, including its 2026 financial guidance; its expectations regarding its share repurchase program; the results and timing of the Company’s preclinical studies, clinical trials, regulatory submissions and regulatory approvals; the commercialization and anticipated sales of the Company’s products, including current and planned product launches and any additional product launches from the Company’s generic pipeline; the Company’s estimates of the market opportunity and addressable patient populations for its products; the expansion and execution capabilities of the Company’s sales force for acute gouty arthritis for Cortrophin Gel; the Company’s anticipated growth opportunities, including for Cortrophin Gel and ILUVIEN; the Company’s positioning for continued shareholder value creation; 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 Cortrophin Gel and ILUVIEN, to achieve commercialization at levels of market acceptance that will allow the Company to maintain profitability; the Company’s ability to complete or achieve any or all of the intended benefits of acquisitions and investments, in a timely manner or at all; 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, excipients, 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 Cortrophin Gel and 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, including increased costs due to tariffs or macroeconomic disruptions; the ability of the Company’s manufacturing partners to meet its product demands and timelines; the impact of changes or fluctuations in exchange rates; the Company’s ability to develop, license or acquire, and commercialize new products; the Company’s obligations in agreements under which it licenses, develops or commercializes rights to products or technology from third parties and its ability to maintain such licenses; 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 impact of any litigation to which the Company is, or may become, a party; 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; the Company’s ability to maintain the services of its key executives and other personnel; 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:
Irina Koffler, Vice President, Investor Relations
T: 917-734-7387
E: Irina.koffler@anipharmaceuticals.com
Media Relations:
Argot Partners
T: 212-600-1494
E: ani@argotpartners.com
SOURCE: ANI Pharmaceuticals, Inc.
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1 All statistical analyses are descriptive only, and all p-values are nominal.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did ANI Pharmaceuticals’ SYNCHRONICITY trial show at six and 24 months?
SYNCHRONICITY met both six-month primary endpoints, with mean visual acuity improving by 3.6 letters and central retinal thickness decreasing by 157.5 microns. Both changes were statistically significant. At 24 months, mean changes from baseline were +5.5 letters and −171.2 microns, respectively, in the 108-patient intent-to-treat population.
What safety findings did ANI Pharmaceuticals report from SYNCHRONICITY?
Treatment-related treatment-emergent adverse events occurred in 29% of patients, most commonly ocular hypertension, cataract and reduced visual acuity. Eye-pressure-lowering medication was used by 29.6%, while 7.4% required laser or surgical intervention to lower eye pressure. Cataract surgery was reported in 14.8% of study eyes.
Who was eligible for ANI Pharmaceuticals’ SYNCHRONICITY trial?
Eligible patients had active, recurrent non-infectious uveitis affecting the back of one or both eyes, with a duration of at least three months from initial diagnosis. The study evaluated disease that had responded to previous steroid therapy. Patients who had ocular surgery within 12 weeks of study Day 1 were excluded.
How did ANI Pharmaceuticals’ SYNCHRONICITY trial define inflammation recurrence and macular edema resolution?
Inflammation recurrence was defined as an increase in central retinal thickness of more than 100 microns or by the investigator’s medical judgment. Macular edema resolution required central retinal thickness below 325 microns on Heidelberg SPECTRALIS or below 315 microns on Zeiss CIRRUS imaging.