ANI Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded label for ILUVIEN (fluocinolone acetonide intravitreal implant) to include the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). This approval adds to ILUVIEN's existing indication for diabetic macular edema (DME).
The company plans to begin marketing ILUVIEN in the U.S. under the combined label later this year. The drug is already approved for both DME and NIU-PS in seventeen European countries.
"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," stated Nikhil Lalwani, President and CEO of ANI.
Treatment Indications and Clinical Significance
ILUVIEN is a corticosteroid indicated for two distinct ocular conditions:
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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.
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The treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
This label expansion represents a significant advancement in treatment options for patients with NIU-PS, a serious inflammatory condition that can lead to vision loss if not properly managed. The intravitreal implant provides sustained release of the corticosteroid, potentially reducing the need for frequent injections.
Manufacturing and Supply Chain Security
ANI previously announced an extension of its supply agreement for ILUVIEN with a subsidiary of Siegfried Holding AG through 2029. The companies have agreed to upgrade equipment on the existing manufacturing line and significantly expand production capacity to ensure reliable supply.
This manufacturing partnership strengthens ANI's ability to meet patient needs as the market for ILUVIEN potentially expands with the new indication.
Safety Profile and Monitoring Requirements
As with many ophthalmic corticosteroid treatments, ILUVIEN carries important safety considerations. Clinical trials revealed several adverse reactions, with cataract development being the most common ocular side effect, occurring in 82% of patients treated for DME and 56% of patients treated for NIU-PS.
Intraocular pressure (IOP) elevation is another significant concern, with 34% of ILUVIEN patients in DME trials and 22% in NIU-PS trials experiencing IOP elevation of 10 mm Hg or more from baseline. Healthcare providers must routinely monitor IOP during treatment.
The drug is contraindicated in patients with active or suspected ocular or periocular infections, in patients with glaucoma who have cup to disc ratios greater than 0.8, and in those with known hypersensitivity to any components of the product.
Clinical Trial Results
In clinical trials for NIU-PS, common ocular adverse reactions included cataract (56%), reduced visual acuity (15%), macular edema (11%), and uveitis (10%). For DME patients, the most common adverse reactions were cataract (82%), myodesopsia (21%), eye pain (15%), and conjunctival hemorrhage (13%).
The efficacy data supporting the expanded indication demonstrates ILUVIEN's ability to manage chronic NIU-PS, providing an important treatment option for patients with this challenging condition.
Market Impact and Future Outlook
The expanded label positions ANI Pharmaceuticals to address a broader range of ocular inflammatory conditions. With ILUVIEN now approved for both DME and NIU-PS in the United States, the company can leverage its existing commercial infrastructure to serve additional patients.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company focused on delivering sustainable growth through its Rare Disease business, Generics business, and Brands business. The company markets novel products in ophthalmology, rheumatology, nephrology, neurology, and pulmonology.
As the company prepares to launch ILUVIEN under the expanded label, ophthalmologists and retina specialists will have an additional tool in their armamentarium for treating these serious ocular conditions that can threaten patients' vision and quality of life.
