Product Dossier
OZURDEX
Product Dossier for OZURDEX (dexamethasone, AbbVie). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: AbbVie
- Active ingredient: dexamethasone
- Therapeutic area: Ophthalmology
- Related brand: DEXMETHSONE
- Related brand: OTODEX
- Related brand: SOFRADEX
- Same area: EYLEA
- Same area: OCUFLOX
What it is Ozurdex is a dexamethasone 700 microgram intravitreal implant .
Approved indications
— Macular oedema due to Branch Retinal Vein Occlusion (BRVO) . — Macular oedema due to Central Retinal Vein Occlusion (CRVO) . — Non-infectious uveitis affecting the posterior segment of the eye .
PBS listing
Ozurdex intravitreal injection 700 micrograms is listed on the PBS with authority required restriction at an ex-manufacturer price of A$1091.84 . For diabetic macular oedema, listing is restricted to pseudophakic patients or those scheduled for cataract surgery who have a contraindication to, or have failed to respond to a VEGF inhibitor, or where a VEGF inhibitor is otherwise unsuitable . For non-infectious uveitis affecting the posterior segment of the eye, authority required listing applies where systemic therapy is not required or contraindicated .
Regulatory history
Ozurdex was first listed on the Australian Register of Therapeutic Goods on 4 June 2015 . In March 2016, the PBAC recommended authority required listing for diabetic macular oedema . In November 2017, the PBAC recommended an amendment to allow dexamethasone intravitreal implant for diabetic macular oedema in pseudophakic patients . In November 2017, the PBAC recommended listing for non-infectious posterior segment uveitis where systemic therapy is not required or contraindicated . Ozurdex was approved by the TGA on 6 June 2017 for macular oedema due to branch and central retinal vein occlusion and non-infectious uveitis affecting the posterior segment .