Ozurdex Dosage/Direction for Use

Recommended Dose: For ophthalmic intravitreal injection only. The recommended dose for the treatment of macular edema following BRVO or CRVO and for the treatment of non-infectious uveitis affecting the posterior segment of the eye and for the treatment of diabetic macular edema is 0.7 mg per eye (entire contents of a single-use OZURDEX 0.7 mg device). Re-injection of OZURDEX 0.7 mg for macular edema due to BRVO or CRVO is recommended when there is reoccurrence of macular edema or vascular leakage in the macula.
Mode of Administration: The intravitreal injection procedure should be carried out under controlled aseptic conditions, which include the use of surgical hand disinfection, sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). The patient's medical history for hypersensitivity reactions should be carefully evaluated before performing the intravitreal procedure. The periocular skin, eyelid and ocular surface should be disinfected (for example, drops of povidone iodine 5% solution on the conjunctiva) and adequate local anesthesia and a broad-spectrum topical microbicide should be administered before the injection. Aseptic technique should be maintained at all times before and during the injection procedure.
Remove the foil pouch from the carton and examine for damage. Then, in a sterile field, open the foil pouch and gently place the applicator on a sterile tray. Carefully remove the cap from the applicator. Hold the applicator in one hand and pull the safety tab straight off the applicator. Do not twist or flex the tab. With the long axis of the applicator parallel to the limbus, enter the sclera at a shallow oblique angle with the bevel of the needle up (away from the sclera) to create a partial thickness tract 1-2 mm in length parallel to the limbus (no more than the length of the needle bevel). Re-direct the needle perpendicularly towards the center of the vitreous cavity; this creates a bi-planar self-sealing sclera puncture.
Advance the needle until the vitreous cavity is entered and the silicone sleeve is against the conjunctiva. Do not advance the needle past the point where the sleeve touches the conjunctiva. When re‐directing into the vitreous cavity, allow for the fact that the DDS can be up to 6.5 mm long. Slowly depress the actuator button on the applicator until an audible or palpable click is noted. (Note: On occasion, a smaller, softer click is heard or felt while the button is only partially depressed).
Before withdrawing the applicator from the eye, ensure that the button is fully depressed and has locked flush with the applicator surface. The speed of the DDS injection is proportional to the speed that the button is depressed. Withdraw the needle from the eye back‐tracking along the original entry path if possible.
Following the intravitreal injection, patients should be treated with antibiotics and should be monitored. 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.
Each applicator can only be used for the treatment of a single eye.