SUMMARY ILUVIEN R A PHARMACEUTICAL, IS INDICATED FOR THE TREATMENT OF VISUAL IMPAIRMENT DUE TO DIABETIC MACULAR EDEMA (DME) INSUFFICIENTLY RESPONSIVE TO AVAILABLE THERAPY. THE ACTIVE INGREDIENT, FLUOCINOLONE ACETONIDE (FAC), IN ILUVIEN R IS A HALOGENATED CORTICOSTEROID. ILIVIEN R IS AVAILABLE BY PRESCRIPTION ONLY AND IS PACKAGED AS A SINGLE DOSE. THE VALUE OF A UNIT OF ILUVIEN R IS $350. THE ACTIVE INGREDIENT FLUOCINOLONE ACETONIDE IS INCLUDED UNDER THE CUSTOMS NOMENCLATURE CODE 2937220 (HALOGENATED DERIVATIVES OF CORTICOSTEROIDAL HORMONES). HOWEVER THE ILUVIEN R PRODUCT FALLS UNDER THE CUSTOMS NOMENCLATURE CODE 30043900 (MEDICAMENTS, CONTAINING PRODUCTS OF HEADING 2937 NESOI, IN DOSAGE FORM OR PACKED FOR RETAIL). PRODUCT DETAILS: ILUVIEN R CARTON CONTAINS: A SINGLE SUSTAINED RELEASE STERILE INJECTABLE INTRAVITREAL INSERT MADE FROM A TINY HOLLOW POLYIMIDE TUBE CONTAINING 190 UG OF FLUOCINOLONE ACETONIDE (FAC) THAT IS PRELOADED INTO A STERILE DISPOSABLE APPLICATOR. THE APPLICATOR CONSISTS OF A PLASTIC HANDPIECE WITH A STAINLESS STEEL NEEDLE ATTACHED TO A GUIDESHAFT WHERE THE INSERT IS HELD IN PLACE PRIOR TO USE. THE STAINLESS STEEL PUSH ROD IN THE GUIDESHAFT IS ACTIVATED BY SLIDING FORWARD THE BUTTON LOCATED ON TOP OF THE APPLICATOR. THIS ACTION PUSHES THE INSERT INTO THE NEEDLE JUST PRIOR TO INSERTION INTO THE EYE. ONCE THE NEEDLE IS INSIDE THE EYE, THE BUTTON IS AGAIN SLID FORWARD TO DELIVER THE INSERT. THE NEEDLE IS PROTECTED BY A SAFETY CAP. ILUVIEN R IS PACKAGED IN A STERILE PLASTIC TRAY WITH A TYVEK LID. ILUVIEN R IS FOR SINGLE USE ONLY AND IS DESIGNED FOR THE TREATMENT OF A SINGLE EYE. THE TECHNOLOGY INVOLVES THE USE OF A TINY HOLLOW POLYIMIDE CYLINDER (3.5 MM X 0.37MM) CONTAINING FAC WHICH CAN BE INSERTED THROUGH THE PARS PLANA INTO THE OCULAR VITREOUS CHAMBER BY INJECTION THROUGH A 25-GAUGE NEEDLE. THE 25- GAUGE NEEDLE IS MODIFIED TO CONTROL THE INJECTION DEPTH. ILUVIEN R IS DESIGNED TO HAVE AN INITIAL RELEASE RATE OF 0.25 UG/DAY OF FAC AND RELEASES FAC UP TO 30-36 MONTHS. THE PACKAGED PRODUCT IS TERMINALLY STERILIZED BY GAMMA IRRADIATION FOR USE IN AN OUTPATIENT SETTING. THE STORAGE TEMPERATURE RANGE IS 15 – 30C AND THE PROPOSED SHELF LIFE IS 24 MONTHS.FAC IS A MEMBER OF A CLASS OF FLUORINATED (HALOGENATED) SYNTHETIC CORTICOSTEROIDS THAT INCLUDE DEXAMETHASONE, TRIAMCINOLONE ACETONIDE AND FLUOCINONIDE. FAC IS QUANTITATIVELY DETERMINED BY HIGH PRESSURE LIQUID CHROMATOGRAPHY (HPLC) AS A QUALITY REQUIREMENT BEFORE BEING APPROVED AS A FINISHED PRODUCT. THE CHEMICAL NAME FOR FLUOCINOLONE ACETONIDE IS: PREGNA-1,4-DIENE-3,20-DIONE, 6,9-DIFLUORO-11,21-DIHYDROXY-16,17-(1-METHYL-ETHYLIDENE)BIS(OXY)1-, (6A, 1 1B, 16A)-. THE INSERT IS MADE FROM THE FOLLOWING MATERIALS: POLYIMIDE-INACTIVE INGREDIENT. POLYVINYL ALCOHOL (PVA) – INACTIVE INGREDIENT. SILICONE ADHESIVE – INACTIVE INGREDIENT. WATER FOR INJECTION – INACTIVE INGREDIENT. FLUOCINOLONE ACETONIDE – ACTIVE INGREDIENT. THE APPLICATOR IS MADE FROM THE FOLLOWING MATERIALS: 304 STAINLESS STEEL. ZYLAR 220 (ACRYLIC). LUSTRAN 348-012002 (ABS). SANTOPRENE TPV 8271-55B100. METHOD OF PRODUCTION: INJECTION MOULDING. MACHINING. MANUAL ASSEMBLY. MANUAL AND AUTOMATED PACKAGING. MANUAL FORMULATION OF THE FAC COMPOUND

CLASSIFICATION HAS BEEN DETERMINED IN ACCORDANCE WITH THE FOLLOWING : GENERAL INTERPRETATIVE RULES (GIR)S GIR 1 HAS BEEN USED TO CLASSIFY THIS PRODUCT BY THE TERMS OF HEADING 3004 - MEDICAMENTS, CONSISTING OF MIXED OR UNMIXED PRODUCTS FOR THERAPEUTiC OR PROPHYLACTIC USES, PUT UP IN MEASURED DOSES. GIR 5B HAS BEEN USED TO IDENTIFY THE TYPE OF PACKAGING. GIR 6 HAS BEEN USED TO CLASSIFY THE GOODS TO SUBHEADING LEVEL 300432 - CONTAINING CORTICOSTEROID HORMONES, THEIR DERIVATIVES OR STRUCTURAL ANALOGUES.