Alimera Sciences Inc. (USA) has appointed Alan Pharmaceuticals as exclusive distributor of ILUVIEN® for the UK private market. Alan Pharmaceuticals also welcomes enquiries for ILUVIEN® from outside the UK.
ILUVIEN® is now available for immediate supply.
ILUVIEN® is indicated for the treatment of vision impairment associated with chronic diabetic macular oedema (DMO) considered insufficiently responsive to available therapies. There are believed to be over 180,000 patients within the UK, France and Germany who suffer with clinically significant DMO.
ILUVIEN® 190 micrograms intravitreal implant in applicator is manufactured by Alimera Sciences. The implant delivers 190mcgs of fluocinolone acetonide (FAc).
The implant is a light brown coloured cylinder approximately 3.5mm in length and 0.37mm in diameter (see illustration). Each implant comes pre-loaded in a "use once and discard" applicator and is administered via a direct intravitreal injection using a 25-gauge needle.
ILUVIEN® provides 36 months of consistent fluocinolone acetonide (FAc) from a single micro implant. ILUVIEN® has the potential to provide chronic DMO patients improved visual acuity at 36 months compared with baseline with one sustained-release micro implant (Campochario PA, Brown DM et al. Ophthalmology 2012; 119: 2125-2131).
Only patients who have been insufficiently responsive to prior treatment with laser photocoagulation or other available therapies for DMO should be treated with ILUVIEN®.
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose is one ILUVIEN® implant in the affected eye. Administration in both eyes concurrently is not recommended.
Treatment with ILUVIEN® is for intravitreal use only and should be administered by an ophthalmologist experienced in intravitreal injections. The implant insertion should be carried out under controlled aseptic conditions, which include the use of sterile gloves,
a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anaesthesia and a broad-spectrum microbicide should be given prior to the insertion. Further information on administration can be found in the ILUVIEN® pack insert.
The efficacy of ILUVIEN® was assessed in two randomised, multicentre, double-masked, parallel studies enrolling subjects with DMO who had previously been treated with laser photocoagulation at least once, each involving three years of follow-up.
The primary efficacy endpoint in both trials was the proportion of subjects whose vision improved by 15 letters or greater after 24 months.
In each of these trials, the primary endpoint was met for ILUVIEN® (see left panel in the Figure below).
When efficacy was assessed as a function of duration of disease, those subjects with a duration of DMO greater than the median (=3 years) had a significant beneficial response to ILUVIEN®, whilst those with shorter duration DMO did not show an additional benefit over control treatment with regard to visual improvement (see right panel in the Figure below).
ILUVIEN® is contraindicated in the presence of pre-existing glaucoma or active or suspected ocular or peri-ocular infection including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infections and fungal diseases.
Uncommon (≥1/1000 to ≥1/100) – endophthalmitis, headache
Common (≥1/100 to ≥1/10) – glaucoma, trabeculectomy, eye pain
Very Common(≥1/10) – cataract, increased IOP, floaters (myodesopsia)
Store below 30°C. Do not refrigerate or re-freeze.
MARKETING AUTHORISATION HOLDER
Alimera Sciences Limited, Centaur House, Ancells Business Park, Ancells Road, Fleet, GU51 2UJ UK
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