Pharmac approves Ozurdex

December 14, 2017 NZ Optics

Ozurdex, a long-acting intravitreal steroid, delivered via a sustained-release ocular implant is now available and funded for New Zealand adult diabetic macular oedema (DMO) patients, which is welcome news, say Kiwi retina specialists.

 

“It’s great news because Pharmac has been very reticent to fund new medications for use in the eye, and we’ve found ourselves behind our international colleagues a lot of the time in what we can use to treat our patients, without them getting a big out-of-pocket expense. So, we’re really very excited about this,” said Retina Specialists’ Dr Rachel Barnes at RANZCO 2017.

 

Eye Doctors’ Andrew Riley was involved with the clinical studies on Ozurdex (previously Posurdex) with his colleague, principal investigator, Dr Mark Donaldson, so he knows first-hand the benefits the Ozurdex slow-release system can bring to patients, he said. “It gives you another option, a good option. We haven’t had a second or third line (treatment) as good as this. The treatment load won’t be as bad for patients, and we now have something to better maintain their vision.”

 

Ozurdex is a biodegradable, intravitreal, rod-shaped implant containing 700mcg dexamethasone, which targets inflammatory mediators involved in the generation and regulation of the inflammatory response in DMO. Specially-designed to provide sustained delivery, the implant results in less frequent injections compared to anti-VEGFs.

 

“Diabetes is an ever-increasing problem in New Zealand, and is particularly prevalent in the Maori and Pacific Islander populations. Many of these patients already inject insulin, so the additional burden of frequent injections for DMO can severely affect independence and quality of life,” said Auckland Eye’s Dr Philip Polkinghorne. “For some patients, anti-VEGF treatments are less effective than we would like, so it is important that New Zealanders with diabetes and DMO have access to alternative treatments in order to avoid preventable sight loss.”

 

A recent study showed that more than 35% of patients with DMO fail to achieve ≥10-letter improvement in best-corrected visual acuity (BCVA) after two years of first-line anti-VEGFs. While in clinical trials, Ozurdex delivered a rapid and significant vision improvement of 15 or more letters compared with sham treatment in the whole population of DMO patients; provided sustained, long-term improvements in vision in DMO patients with a mean of four injections over three years, compared with sham treatment: and was found to promote rapid central retinal thickness reduction, with significant and sustained visual gains.

 

The efficacy and tolerability profile of Ozurdex is supported by two, three-year, multicentre, double-masked, randomised, sham-controlled phase III studies involving more than 1,000 patients as part of the MEAD (macular (o)edema: assessment of implantable dexamethasone in diabetes) trials. Only a small percentage of patients in the trial are reported to have experienced adverse ocular events, including: 1.4% with retinal tears and 0.6% for each of retinal detachment, endophthalmitis and hypotony of the eye. Less than one in three patients experienced an IOP increase from baseline of ≥10 mmHg. Elevations in IOP did not have a cumulative effect and were manageable with topical IOP-lowering treatment, reported Allergan.

 

Ozurdex has been approved for the treatment of macular oedema due to retinal vein occlusion; adult patients with visual impairment due to DMO who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy; and non-infectious uveitis affecting the posterior segment of the eye.