- 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
ANI Pharmaceuticals, Inc. announced that the 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 17 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 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.
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