SMO1 intravitreal implant 700μg (dexamethasone)

• Appearance: White to yellowish white rod-shaped implant contained in an applicator

                     Implant size: 0.46 x 6 mm

•Active ingredient: Dexamethasone 700μg

•Additives: Lisomer RG 502, poly(D,L-lactide-co-glycolide), Lisomer RG 502H, poly(D,L-lactide-co-glycolide), needle

•Effectiveness

1) Treatment of macular edema that appears after branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)

2) Treatment of non-infectious uveitis accompanied by posterior segment inflammation

3) Treatment of diabetic macular edema

- After a single administration Effective for macular edema treatment for approximately 6 several months

•Administration & Dosage

One implant (700ug of dexamethasone) must be injected into the vitreous only.

Intravitreal administration procedures must be performed under sterile conditions (sterile gloves, sterile cloth, sterile opener).

Periocular area before and on the day of administration. The use of appropriate anesthetics and broad-spectrum antibacterial agents for the skin, eyelids, and ocular surfaces is recommended.

•How to apply

• Packed in aluminum foil in product box Take out the applicator and check that there are no damaged parts, open it in a sterilized place and place the applicator on a sterile workbench.

• Carefully open the cap of the applicator. Hold the applicator with one hand and remove the applicator's safety stopper by pulling it straight. Do not twist or bend the stopper.

• The long axis of the applicator should be parallel to the corneal limbus, and the inclined side of the needle should be pointed upward (away from the sclera). It must enter the sclera at an oblique angle so that the scleral penetration path is created obliquely. When the tip of the needle has advanced approximately 1mm within the sclera (parallel to the limbus), change the direction toward the center of the eye and proceed until it completely penetrates the sclera and enters the vitreous cavity. The needle should not be advanced past the point where the needle starts touching the conjunctiva.

• Slowly press the operation button until a click sound is heard. Before removing the applicator from the eye, ensure that the activation button is fully pressed and flush with the applicator surface. Remove the needle in the same direction it was used when inserting it into the vitreous body. After intravitreal administration, patients should be observed for increased intraocular pressure and endophthalmitis.