ILUVIEN- fluocinolone acetonide implant
Alimera Sciences, Inc.
ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg is 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.
For ophthalmic intravitreal injection.
The intravitreal injection procedure should be carried out under aseptic conditions, which include use of sterile gloves, a sterile drape, a sterile caliper, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection.
The injection procedure for ILUVIEN is as follows:
- The exterior of the tray should not be considered sterile. An assistant (non-sterile) should remove the tray from the carton and examine the tray and lid for damage. If damaged, do not use unit.
If acceptable, the assistant should peel the lid from the tray without touching the interior surface.
- Visually check through the viewing window of the preloaded applicator to ensure that there is a drug implant inside.
- Remove the applicator from the tray with sterile gloved hands touching only the sterile interior tray surface and applicator.
Prior to injection, the applicator tip must be kept above the horizontal plane to ensure that the implant is properly positioned within the applicator.
- To reduce the amount of air administered with the implant, the administration procedure requires two steps. Before inserting the needle into the eye, remove the protective cap then gently push the applicator button down and slide it to the first stop (at the curved black marks alongside the button track). At the first stop, release the button and it should move to the UP position. If the button does not rise to the UP position, do not proceed with this unit.
- Optimal placement of the implant is inferior to the optic disc and posterior to the equator of the eye. Measure 4 millimeters inferotemporal from the limbus with the aid of calipers for point of entry into the sclera.
- Inspect the tip of the needle to ensure it is not bent.
- Gently displace the conjunctiva so that after withdrawing the needle, the conjunctival and scleral needle entry sites will not align. Care should be taken to avoid contact between the needle and the lid margin or lashes. Insert the needle through the conjunctiva and sclera. To release the implant, while the button is in the UP position, advance the button by sliding it forward to the end of the button track and remove the needle. Note: Ensure that the button reaches the end of the track before removing the needle.
- Remove the lid speculum and perform indirect ophthalmoscopy to verify placement of the implant, adequate central retinal artery perfusion and absence of any other complications.
Following the injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy between two and seven days following the injection. Patients should be instructed to report without delay any symptoms suggestive of endophthalmitis.
ILUVIEN is a non-bioerodable intravitreal implant in a drug delivery system containing 0.19 mg fluocinolone acetonide, designed to release fluocinolone acetonide at an initial rate of 0.25 μg/day and lasting 36 months.
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.
Intravitreal injections, including those with ILUVIEN , have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored following the intravitreal injection [see Patient Counseling Information (17)].
Use of corticosteroids including ILUVIEN may produce posterior subcapsular cataracts, increased intraocular pressure and glaucoma. Use of corticosteroids may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.
Corticosteroids are not recommended to be used in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection.
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.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions associated with ophthalmic steroids including ILUVIEN include cataract formation and subsequent cataract surgery, elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.
ILUVIEN was studied in two multicenter, randomized, sham-controlled, masked trials in which patients with diabetic macular edema (DME) were treated with either ILUVIEN (n=375) or sham (n=185).
Table 1 summarizes safety data available when the last subject completed the last 36 month follow up visit for the two primary ILUVIEN trials. In these trials, subjects were eligible for retreatment no earlier than 12 months after study entry. Over the three year follow up period, approximately 75% of the ILUVIEN treated subjects received only one ILUVIEN implant.
|1 Includes cataract, cataract nuclear, cataract subcapsular, cataract cortical and cataract diabetic in patients who were phakic at baseline. Among these patients, 80% of ILUVIEN subjects vs. 27% of sham-controlled subjects underwent cataract surgery.|
|2 235 of the 375 ILUVIEN subjects were phakic at baseline; 121 of 185 sham-controlled subjects were phakic at baseline.|
|Adverse Reactions||ILUVIEN (N=375) n (%)||Sham (N=185) n (%)|
|Cataract1||192/2352 (82%)||61/1212 (50%)|
|Myodesopsia||80 (21%)||17 (9%)|
|Eye pain||57 (15%)||25 (14%)|
|Conjunctival haemorrhage||50 (13%)||21 (11%)|
|Posterior capsule opacification||35 (9%)||6 (3%)|
|Eye irritation||30 (8%)||11 (6%)|
|Vitreous detachment||26 (7%)||12 (7%)|
|Conjunctivitis||14 (4%)||5 (3%)|
|Corneal oedema||13 (4%)||3 (2%)|
|Foreign body sensation in eyes||12 (3%)||4 (2%)|
|Eye pruritus||10 (3%)||3 (2%)|
|Ocular hyperaemia||10 (3%)||3 (2%)|
|Optic atrophy||9 (2%)||2 (1%)|
|Ocular discomfort||8 (2%)||1 (1%)|
|Photophobia||7 (2%)||2 (1%)|
|Retinal exudates||7 (2%)||0 (0%)|
|Anterior chamber cell||6 (2%)||1 (1%)|
|Eye discharge||6 (2%)||1 (1%)|
|Anemia||40 (11%)||10 (5%)|
|Headache||33 (9%)||11 (6%)|
|Renal Failure||32 (9%)||10 (5%)|
|Pneumonia||28 (7%)||8 (4%)|
Increased intraocular Pressure
|Event||ILUVIEN (N=375) n (%)||Sham (N=185) n (%)|
|IOP elevation ≥ 10 mmHg from Baseline||127 (34%)||18 (10%)|
|IOP elevation ≥ 30 mmHg||75 (20%)||8 (4%)|
|Any IOP-lowering medication||144 (38%)||26 (14%)|
|Any surgical intervention for elevated intraocular pressure||18 (5%)||1 (1%)|
Figure 1: Mean IOP during the study
Cataracts and Cataract SurgeryAt baseline, 235 of the 375 ILUVIEN subjects were phakic; 121 of 185 sham-controlled subjects were phakic. 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 vs. 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.
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