ANI Pharmaceuticals, Inc. has received FDA approval for an expanded label of ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg for the treatment of chronic non-infectious uveitis (NIU) affecting the posterior segment of the eye (NIU-PS).
This marks the second ophthalmic approval for the company since its September 2024 acquisition of Alimera Sciences, Inc.—with the first (Purified Cortrophin Gel PFS) secured earlier this month.
First, some background on ILUVIEN.
Developed by the now-former Alimera, the sustained-release intravitreal (IVT) implant was originally approved by the FDA in 2014 (and before that, in 1963).
- Its indication: For the treatment of diabetic macular edema (DME) in patients who previously received corticosteroid therapy and did not exhibit a significant increase in intraocular pressure (IOP).
Outside the United States: The implant is already approved for DME in Canada, Kuwait, Lebanon, and the United Arab Emirates (as well as in 17 European countries for NIU-PS).
And its mechanism of action?
Upon approval, it became the first DME treatment to deliver 36 months of continuous, low-dose corticosteroid (fluocinolone acetonide) via a single injection—at an initial rate of 0.25 µg/day.
Notably: This timeframe and mode of delivery apply to the NIU-PS indication as well, carried out under aseptic conditions.
- See here for ILUVIEN’s full prescribing information (PI), which includes an updated warnings and precautions section to align with its new indication.
So what warnings and precautions are associated with use?
Patient monitoring is advised following injection of ILUVIEN, as IVT injections have known associations with:
- Endophthalmitis
- Ocular inflammation
- Increased IOP
- Retinal detachments
Other potential developments include: Cataracts; delayed corneal wound healing; corneal and scleral melting; bacterial, fungal, or viral infections; and implant migration (into the anterior chamber).
Any adverse reactions to keep in mind?
Cataract development and myodesopsia (eye floaters) were reported as the most common ocular adverse reactions based on clinical research—occurring in ≥1% of patients—followed by:
- Ocular pain
- Conjunctival hemorrhage
- Eye irritation
- Vitreous detachment
- Corneal edema
See the PI for the complete list (skip ahead to page 5).
And take note: These reactions were based on clinical evaluation of DME (not NIU-PS) patients—although, notably, not in the currently active and ongoing phase 3 NEW DAY trial [NCT04469595]).
How about contraindications?
ILUVIEN is contraindicated in patients with:
- Active or suspected ocular or periocular infections, including most viral diseases of the cornea and conjunctiva: active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases
- Glaucoma who have cup-to-disc ratios of > 0.8
- Known hypersensitivity to any components of the product
Gotcha. So what’s the plan for this expanded ILUVIEN label?
As ANI reported, the company intends to begin product marketing under the combined DME and NIU-PS label later this year.
ANI President and CEO Nikhil Lalwani added that this expanded label—”and the strengthening of our partnership with long-standing ILUVIEN contract manufacturer, Seigfried”—will advance the product’s supply chain security and access to its updated target patient base.
- Stay tuned for more details (and, in the meantime, click here for questions on accessing ILUVIEN).