Fluocinolone acetonide micro-insert intravitreous implant

Trial met both co-primary endpoints of mean change from baseline in BCVA letter score and mean change from baseline CST with statistical significance at 6 months 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. Full results to be presented at an upcoming medical meeting PRINCETON, N.J., July 13, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced positive topline data from its Phase 4, open-label, single-arm SYNCHRONICITY clinical trial of Fluocinolone Acetonide Intravitreal Implant in patients with chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS). Both co-primary endpoints assessing 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 at 6 months in the intent-to-treat (ITT) population (n=108) were met with statistical significance. Patients in the ITT population had a mean change in 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). Patients in the ITT population had a mean change in baseline CST of -157.5 microns (p= <.0001) at 6 months (mean CST of 505.7 microns at baseline compared to 348.8 microns at month 6). The most common adverse events seen in SYNCHRONICITY were consistent with prior trials of the fluocinolone acetonide intravitreal implant. In the safety population, 29% of patients (n=31/108) experienced treatment-related treatment-emergent adverse events; the most common were ocular hypertension in 6% of patients (n=7) and cataract in 5% of patients (n=5). Separately, 18% of patients (n=19/108) experienced an IOP increase of ≥25 mmHg, and 7% of patients (n=8/108) required any laser or surgical IOP-lowering intervention. Detailed results and additional analyses will be presented at medical conferences in 4Q 2026. “We are encouraged by the positive results from the SYNCHRONICITY trial, which continue to 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 look forward to sharing detailed results at medical conferences and continuing to engage the retina community.” “ILUVIEN is an established treatment option for patients with chronic non-infectious uveitis affecting the posterior segment of the eye. The SYNCHRONICITY study adds clinically meaningful data about the use of ILUVIEN for the treatment of chronic NIU-PS in patients we see every day in our retina practices,” said David Almeida, MD, MBA, PhD, President and CEO of Erie Retina Research, and Principal Investigator in SYNCHRONICITY. 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 (intraocular inflammation) 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 participants were female (65%). The mean (SD) central subfield thickness (CST) was 505.7 (141.3) microns. Baseline BCVA in the study eye had a mean (SD) of 62.5 (11.6) ETDRS letters. At baseline, 69% of study participants had a history of ocular surgery prior to enrollment. However, patients were excluded from the study if they had ocular surgery within 12 weeks of Day 1 of the study. 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 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. Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye Ocular adverse reactions reported by greater than or equal to 1% of patients in the three combined clinical trials through 12 months following injection of fluocinolone acetonide intravitreal implant: cataract (56%), visual acuity reduced (15%), macular edema (11%), uveitis (10%), conjunctival hemorrhage (8%), eye pain (8%), hypotony of eye (7%), anterior chamber inflammation (5%), dry eye (4%), vitreous opacities (4%), conjunctivitis (4%), posterior capsule opacification (4%), ocular hyperemia (4%), vitreous haze (3%), foreign body sensation in eyes (3%), vitritis (3%), vitreous floaters (3%), eye pruritus (3%), conjunctival hyperemia (2%), ocular discomfort (2%), macular fibrosis (2%), glaucoma (2%), photopsia (2%), vitreous hemorrhage (2%), iridocyclitis (1%), eye inflammation (1%), choroiditis (1%), eye irritation (1%), visual field defect (1%), and lacrimation increased (1%). Non-ocular adverse reactions reported by greater than or equal to 2% of patients include: nasopharyngitis (5%), hypertension (3%), and arthralgia (2%). Increased Intraocular Pressure: IOP elevation greater than or equal to 10 mm Hg from baseline at any visit was seen in 22% of fluocinolone acetonide patients versus 12% of sham patients. IOP elevation greater than or equal to 30 mm Hg was seen in 12% of fluocinolone acetonide patients versus 3% of sham patients. 43% of the patients who received fluocinolone acetonide were subsequently treated with IOP-lowering medications during the study versus 41% of sham patients. 2% of the patients who received fluocinolone acetonide needed surgical intervention for elevated IOP versus 2% of sham patients. 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 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 . 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 plans with respect to 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; expansion plans for the Rare Disease business, including with respect to the expansion and execution capabilities of the Company’s sales force for acute gouty arthritis; anticipated growth opportunities for Cortrophin Gel and 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 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; 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.