Dexamethasone implant authorized for DME

September 17, 2014

The European Commission has extended marketing authorization for an intravitreal implant with 700 mcg of dexamethasone in an applicator (Ozurdex, Allergan) for the treatment of adults with visual impairment caused by diabetic macular oedema (DME) who have pseudophakia or whose condition is considered insufficiently responsive to or unsuitable for non-corticosteroid therapy.

The European Commission has extended marketing authorization for an intravitreal implant with 700 mcg of dexamethasone in an applicator (Ozurdex, Allergan) for the treatment of adults with visual impairment caused by diabetic macular oedema (DME) who have pseudophakia or whose condition is considered insufficiently responsive to or unsuitable for non-corticosteroid therapy.

“This is good news because [dexamethasone] therapy can potentially improve the quality of life for patients with DME by resolving their macular oedema, improving their visual function for daily activities such as reading and driving, and by reducing the burden of very frequent hospital visits with just four to five injections required over 3 years,” said Professor Yit Yang, consultant ophthalmic surgeon from Wolverhampton Eye Infirmary and Birmingham and Midland Eye Centre.

The safety and efficacy of the implant in the management of patients with DME was assessed in the MEAD clinical trials program, two 3-year, multicentre, double-masked, randomized controlled phase III studies of more than 1,000 patients who received either 350 mcg or 700 mcg of the drug or sham (simulated) injections. The results showed:

  • The percentage of patients with a 15 or more letter gain was significantly greater in those treated with dexemethasone than sham at 3 years.
  • Meaningful treatment benefit was observed with a mean of 4 to 5 injections over 3 years.
  • Rapid onset of treatment benefit was observed after the first and repeated dexamethasone injections.
  • Treatment with 700 mcg of dexamethasone was generally well-tolerated with manageable adverse effects. The drug demonstrated good systemic safety. Common adverse events included elevated IOP and cataract, consistent with previous observations.

The implant is already available in the UK as a treatment licensed for macular oedema in patients with retinal vein occlusion and for inflammation of the posterior segment of the eye characterized as non-infectious uveitis.