New real world evidence from the world’s largest prospective,1,2 phase IV study of Ozurdex (dexamethasone) intravitreal implant in patients with diabetic macular oedema (DME) showed improved outcomes across two patient populations: in the first-line setting, as well as those refractory to anti- VEGF treatment.1,2
AUSSIEDEX, an open-label Phase IV study, is uniquely Australian-focussed, involving ophthalmologists and patients from 25 specialist Australian clinics across the country.1,2
Associate Professor Samantha Fraser-Bell, University of Sydney, presented the results in September at the EURETINA 2019 congress in Paris, and explained their importance.
“Over 1.7 million Australians are currently living with diabetes4,5 and have an increased risk of developing eye complications,4,5 including complete loss of vision,4,5 which can obviously have huge personal and economic impacts,”4,5,8,10 she said. “DME is the leading cause of preventable vision loss from diabetes,6 affecting an estimated 72,000 Australians.4.5 Regular screening for early detection, combined with effective management of DME, is essential.7 (The) results are significant for clinicians and patients alike, furthering our understanding of Ozurdex as a safe and effective treatment for DME.”1,2
As a major and growing cause of vision impairment, the burden of DME on patients, their families and our society is significant.8-10 The indirect costs of vision loss associated with DME on the Australian economy is estimated to be over AU$2 billion.5 This is largely due to many people’s inability to work ($553 million lost to lower employment), or not being able to work at full capacity (an additional $4 million lost to absenteeism).5 “
The findings released today contribute to a growing body of evidence supporting the use of Ozurdex for the treatment of patients with Diabetic Macular Oedema in line with TGA approved indications and PBS criteria. 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”, said George Labib, Medical Director, Allergan Australia and New Zealand.
The study, involving 200 patients with vision loss due to DME, showed Ozurdex significantly improved both best-corrected visual acuity (BCVA) and central macular thickness (CMT) at 12 months for the 55 treatment-naive patients (P=0.042 and P<0.001, respectively).1 In this arm of the study, not only did treatment with Ozurdex meet both of its primary endpoints, significant improvements were demonstrated as early as week six for both BCVA and CMT.1 For the 142 patients refractory to anti-VEGF treatment, Ozurdex significantly improved CMT at 12 months (P<0.001), and mean change in BCVA was significantly improved at weeks six and 24 (P<0.001).2
The safety and tolerability profile of Ozurdex was consistent with previous clinical trials.11 Adverse reactions included increased intraocular pressure (IOP) that required treatment in 25% of treatment-naive patients at 12 months, leading to one treatment discontinuation and no serious ocular adverse events.1 In the treatment-refractory arm, increased IOP required treatment in 20% of patients at 12 months, leading to one treatment discontinuation. One increase in IOP was deemed a serious treatment-related adverse event that was resolved with medication.2
Further results from the study will be presented at the Annual Academy of Ophthalmology (AAO) meeting, this month (October). The biodegradable, intravitreal implant containing 700 μg of dexamethasone, is implanted by an ophthalmologist, via a single use applicator. It slowly releases dexamethasone directly to the retina over several months. Ozurdex is associated with a reduced injection frequency compared with other therapies (VEGF inhibitors).12
- Fraser-Bell S et al. Dexamethasone Intravitreal Implant in Treatment-Naïve Diabetic Macular Edema – Findings from the Prospective, Multicenter, AUSSIEDEX Study. Presented at EURETINA, 06 Sep 2019, Paris, France.
- Arnold J et al. Dexamethasone Intravitreal Implant in Diabetic Macular Edema Refractory to Anti-Vascular Endothelial Growth Factor Therapy – A Subgroup Analysis of the Phase 4, Open-label, Non-randomized, Prospective AUSSIEDEX Study. Presented at EURETINA, 06 Sep 2019, Paris, France.
- Boyer DS et al. Ophthalmology. 2014;121(10):1904-14
- Diabetes Australia. Diabetes in Australia. Viewed August 2019. Available from: https://www.diabetesaustralia.com.au/diabetes-in-australia
- Deloitte Access Economics Pty Ltd. The Economic Impact of Diabetic Macular Oedema in Australia. Viewed August 2019. Available from: http://static.diabetesaustralia.com.au/s/fileassets/diabetes-australia/056496c5-3e1f-40d7-8875-bf085209ce8b.pdf
- Lightman S and Towler HM. Clin Cornerstone. 2003;5(2):12–21.
- Ciulla TA et al. Diabetes Care. 2003;26(9):2653-2664.
- Gonder JR et al. J Ophthalmol. 2014;2014:939315.
- Sivaprasad S, Oyetunde S. Clin Ophthalmol. 2016;10:939-46.
- Hariprasad, SM et al. Br J Ophthalmol. 2008;92(1):89-92.
- Allergan. OZURDEX® Product Information.
- Fraser-Bell S, et al. Ophthalmology 2016;123:1399–401.