ANI Pharmaceuticals Announces FDA Approval for Expansion of ILUVIEN® Label
ANI Pharmaceuticals (ANIP) has received FDA approval for an expanded label of ILUVIEN (fluocinolone acetonide intravitreal implant) to include treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS), in addition to its existing diabetic macular edema (DME) indication.
The company plans to market ILUVIEN for both indications in the U.S. later this year. The treatment is already approved for both DME and NIU-PS in seventeen European countries. ANI has extended its supply agreement with Siegfried through 2029, including plans to upgrade equipment and expand manufacturing capacity.
ILUVIEN is specifically indicated for DME patients previously treated with corticosteroids without significant intraocular pressure rise, and for chronic NIU-PS treatment. The treatment carries important safety considerations, including risks of infection, increased intraocular pressure, cataracts, and delayed wound healing.
ANI Pharmaceuticals (ANIP) ha ricevuto l'approvazione della FDA per un'etichetta ampliata di ILUVIEN (impianto intravitreale di fluocinolone acetonide) che include il trattamento della uveite non infettiva cronica che colpisce il segmento posteriore dell'occhio (NIU-PS), oltre all'indicazione esistente per l'edema maculare diabetico (DME).
L'azienda prevede di commercializzare ILUVIEN per entrambe le indicazioni negli Stati Uniti entro la fine di quest'anno. Il trattamento è già approvato per sia DME che NIU-PS in diciassette paesi europei. ANI ha esteso il suo accordo di fornitura con Siegfried fino al 2029, comprese le pianificazioni per aggiornare le attrezzature e ampliare la capacità produttiva.
ILUVIEN è specificamente indicato per i pazienti con DME precedentemente trattati con corticosteroidi senza un significativo aumento della pressione intraoculare, e per il trattamento della NIU-PS cronica. Il trattamento presenta importanti considerazioni di sicurezza, inclusi i rischi di infezione, aumento della pressione intraoculare, cataratte e ritardo nella guarigione delle ferite.
ANI Pharmaceuticals (ANIP) ha recibido la aprobación de la FDA para una etiqueta ampliada de ILUVIEN (implante intravítreo de fluocinolona acetonida) que incluye el tratamiento de la uveítis no infecciosa crónica que afecta al segmento posterior del ojo (NIU-PS), además de su indicación existente para el edema macular diabético (DME).
La empresa planea comercializar ILUVIEN para ambas indicaciones en los EE. UU. más tarde este año. El tratamiento ya está aprobado para DME y NIU-PS en diecisiete países europeos. ANI ha extendido su acuerdo de suministro con Siegfried hasta 2029, incluyendo planes para actualizar el equipo y expandir la capacidad de fabricación.
ILUVIEN está específicamente indicado para pacientes con DME que han sido tratados previamente con corticosteroides sin un aumento significativo de la presión intraocular, y para el tratamiento de NIU-PS crónica. El tratamiento conlleva importantes consideraciones de seguridad, incluidos los riesgos de infección, aumento de la presión intraocular, cataratas y retraso en la cicatrización de heridas.
ANI Pharmaceuticals (ANIP)는 ILUVIEN (플루오시놀론 아세토나이드 유리체 내 임플란트)의 확장된 라벨에 대한 FDA 승인을 받았으며, 이는 눈의 후방 세그먼트에 영향을 미치는 만성 비감염성 포도막염(NIU-PS) 치료를 포함하고 있습니다. 이는 기존의 당뇨병성 황반부종(DME) 적응증 외에도 포함됩니다.
회사는 올해 말에 미국에서 두 가지 적응증 모두에 대해 ILUVIEN을 판매할 계획입니다. 이 치료법은 이미 17개 유럽 국가에서 DME와 NIU-PS 모두에 대해 승인되었습니다. ANI는 2029년까지 Siegfried와의 공급 계약을 연장했으며, 장비 업그레이드 및 생산 능력 확장을 계획하고 있습니다.
ILUVIEN은 이전에 코르티코스테로이드로 치료받은 DME 환자 및 만성 NIU-PS 치료에 대해 특별히 적응증을 가지고 있습니다. 이 치료는 감염, 안압 상승, 백내장 및 상처 치유 지연과 같은 중요한 안전 고려 사항을 동반합니다.
ANI Pharmaceuticals (ANIP) a reçu l'approbation de la FDA pour un label élargi de ILUVIEN (implant intravitré de fluocinolone acétonide) pour inclure le traitement de l'uvéite non infectieuse chronique affectant le segment postérieur de l'œil (NIU-PS), en plus de son indication existante pour l'œdème maculaire diabétique (DME).
L'entreprise prévoit de commercialiser ILUVIEN pour les deux indications aux États-Unis plus tard cette année. Le traitement est déjà approuvé pour DME et NIU-PS dans dix-sept pays européens. ANI a prolongé son accord de fourniture avec Siegfried jusqu'en 2029, y compris des plans pour moderniser l'équipement et augmenter la capacité de production.
ILUVIEN est spécifiquement indiqué pour les patients atteints de DME ayant été précédemment traités avec des corticostéroïdes sans augmentation significative de la pression intraoculaire, et pour le traitement de la NIU-PS chronique. Le traitement comporte d'importantes considérations de sécurité, y compris des risques d'infection, une augmentation de la pression intraoculaire, des cataractes et un retard de cicatrisation.
ANI Pharmaceuticals (ANIP) hat die FDA-Zulassung für ein erweitertes Label von ILUVIEN (intravitreal Implantat mit Fluocinolon-Acetonid) erhalten, das die Behandlung von chronischer nicht-infektiöser Uveitis, die den hinteren Abschnitt des Auges betrifft (NIU-PS), neben der bestehenden Indikation für diabetisches Makulaödem (DME) umfasst.
Das Unternehmen plant, ILUVIEN später in diesem Jahr in den USA für beide Indikationen auf den Markt zu bringen. Die Behandlung ist bereits in siebzehn europäischen Ländern sowohl für DME als auch NIU-PS zugelassen. ANI hat seine Liefervereinbarung mit Siegfried bis 2029 verlängert, einschließlich Plänen zur Aufrüstung der Ausrüstung und zur Erweiterung der Produktionskapazität.
ILUVIEN ist speziell für DME-Patienten vorgesehen, die zuvor mit Kortikosteroiden behandelt wurden, ohne dass es zu einem signifikanten Anstieg des Augeninnendrucks kam, sowie für die Behandlung von chronischem NIU-PS. Die Behandlung birgt wichtige Sicherheitsaspekte, einschließlich Infektionsrisiken, erhöhtem Augeninnendruck, Katarakten und verzögerter Wundheilung.
- FDA approval expands market opportunity with new NIU-PS indication
- Extended manufacturing agreement with Siegfried through 2029 ensures supply security
- Planned manufacturing capacity expansion to meet increased demand
- Already established presence in 17 European countries for both indications
- Significant safety risks including infections, increased eye pressure, and cataracts
- High incidence of adverse reactions (82% cataract in DME patients)
- Requires careful patient monitoring and potential additional treatments for side effects
Insights
ANI Pharmaceuticals has secured FDA approval for a significant label expansion of ILUVIEN (fluocinolone acetonide intravitreal implant), adding chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) to its existing indication for diabetic macular edema (DME).
This regulatory win represents a meaningful market opportunity expansion for ANI's ophthalmology portfolio. ILUVIEN now addresses two distinct eye conditions with a single product, potentially driving increased prescription volume and revenue growth. The expanded indication leverages ANI's existing commercial infrastructure, creating operational efficiencies while opening access to a new patient population.
The label expansion aligns with ANI's previously announced manufacturing improvements through its extended partnership with Siegfried through 2029, including equipment upgrades and capacity expansion - suggesting the company anticipates increased demand. This dual-indication approval mirrors ILUVIEN's status in 17 European countries, where the product has already established a presence in both treatment areas.
For investors, this approval strengthens ANI's specialty pharmaceutical position by maximizing the commercial potential of an existing asset. The expansion into NIU-PS represents a strategic diversification that could help insulate the product from competitive pressures in any single indication while potentially extending its commercial lifecycle.
- ILUVIEN now approved for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in addition to diabetic macular edema (DME)
- ANI plans to begin marketing ILUVIEN in the U.S. under the combined label later this year
BAUDETTE, Minn., March 14, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for ILUVIEN (fluocinolone acetonide intravitreal implant) that includes an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). The approval also includes other updates to the label including to the Warnings and Precautions section. As previously announced, the Company plans to market ILUVIEN for chronic NIU-PS in addition to its current indication of diabetic macular edema (DME) in the U.S. ILUVIEN is already approved for both DME and NIU-PS outside the U.S., including in seventeen European countries.
Nikhil Lalwani, President and CEO of ANI stated, “ILUVIEN’s expanded label and the strengthening of our partnership with long-standing ILUVIEN contract manufacturer, Seigfried, will enhance supply security and access for appropriate NIU-PS and DME patients in need.”
ANI previously announced that it extended its supply agreement for ILUVIEN with a subsidiary of Siegfried Holding AG (Seigfried) through 2029. Siegfried and ANI also agreed to upgrade equipment on the existing manufacturing line and significantly expand capacity.
INDICATIONS
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.
- the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
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. 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: Use of corticosteroids including ILUVIEN may produce posterior subcapsular cataracts.
- 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.
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 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,” 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 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 recent acquisition of Alimera; the risks that our acquisitions and investments, including the recent 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; 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; 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, 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 Contact Lisa M. Wilson, In-Site Communications, Inc.
212-452-2793
lwilson@insitecony.com
SOURCE: ANI Pharmaceuticals, Inc.
FAQ
What is the new FDA-approved indication for ILUVIEN (ANIP) in 2025?
When will ANI Pharmaceuticals begin marketing ILUVIEN under the new expanded label?
How long is ANI's supply agreement with Siegfried for ILUVIEN manufacturing?
In how many European countries is ILUVIEN already approved for both DME and NIU-PS?
