A significant Australian study into the effectiveness of Allergan’s Ozurdex implant as a treatment for Diabetic Macular Oedema (DME) has shown positive results consistent with previously published evidence.
Associate Professor Samantha Fraser-Bell presented the latest findings at the EURETINA 2019 congress in Paris this week.
“DME is the leading cause of preventable vision loss from diabetes, affecting an estimated 72,000 Australians,” Fraser-Bell said.
“Today’s results are significant for clinicians and patients alike, furthering our understanding of Ozurdex as a safe and effective treatment for DME.”
The findings are the result of the ‘Aussiedex’ study, the largest, open-label, non-randomised Phase IV study of Ozurdex in patients with DME. It featured 200 participants split in to two groups: one treatment naïve, and the other refractory to anti-VEGF treatment.
Throughout the study Ozdurex significantly improved both best-corrected visual acuity (BCVA) and central macular thickness (CMT) at 12 months for the 55 patients receiving treatment for the first time. Among those who had received unsuccessful anti-VEGF treatment in the past, CMT improved at 12 months and BCVA significantly improved at both week six and 24.
Adverse reactions included increased intraocular pressure (IOP) among treatment naïve patients, with 25% requiring treatment at 12 months. There was only one treatment discontinuation and no serious ocular adverse events. For patients refractory to anti-VEGF treatment, 20% required treatment for increased IOP at 12 months, with one discontinuation and one serious treatment-related adverse event that was resolved with medication.
“The findings released today contribute to a growing body of evidence supporting the use of Ozurdex for the treatment of patients with Diabetic Macular Oeda in line with TGA approved indications and PBS criteria,” Dr George Labib, medical director of Allergan Australia and New Zealand, said.
“These include DME patients who are pseudophakic or scheduled for cataract surgery and have not responded sufficiently to anti-VEGF therapy, as well as appropriate naive patients who are unsuitable for anti-VEGF therapy.”
An Allergan spokesperson told Insight that Australia was a favourable location for the study.
“As well as Australia representing a growing hub of innovation in the ophthalmology research field, there is a high Ozurdex prescriber and patient base here, with many world-leading specialist clinics across the country.”
Further results from the study will be presented in October at the Annual Acady of Ophthalmology Annual Meeting in San Francisco.