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Thursday / November 14.
HomeminewsOzurdex: Approved for Non-infectious Uveitis Treatment

Ozurdex: Approved for Non-infectious Uveitis Treatment

Ozurdex (dexamethasone 700μg) sustained release intravitreal implant is listed on the Pharmaceutical Benefits Scheme (PBS) for patients with non-infectious posterior segment uveitis.1 The PBS indication for Ozurdex, a targeted long-acting intravitreal steroid treatment,2 is non-infectious uveitis affecting the posterior segment of the eye, in patients with a documented best corrected visual acuity (BVCA) of 6/12 or worse secondary to vitreous haze or macular oedema. There is no restriction on lens opacity. Further criteria apply.1

Uveitis describes a group of inflammatory diseases characterised by inflammation within the eye that can result in swelling and damage to the tissues within the eye.3,4

Although rare,5 it is serious and, if left untreated or not treated correctly, can lead to complications such as macular oedema and severe vision loss.3,4,6 The cause is not always clear, but in a significant number of cases the inflammation may be a result of autoimmune diseases such as sarcoidosis or ankylosing spondylitis.4,7

Associate Professor Lyndell Lim, from the Centre for Eye Research Australia, University of Melbourne, and Specialist Ophthalmologist and Senior Associate at Eye Surgery Associates, commented, “Until now, the mainstay treatments for uveitis have included systemic corticosteroids, locally applied corticosteroid drops and offlabel intra ocular or periocular corticosteroid injections.8 However, many patients are intolerant or resistant to systemic corticosteroids, and long term use can result in serious side effects including osteoporosis, diabetes and hypertension.8,9 While corticosteroid drops are an alternative option in anterior uveitis, they are ineffective in posterior and intermediate uveitis, which are responsible for most of the severe vision loss related to uveitis.8

Ozurdex delivered rapid and significant visual gains that were sustained at every time point over six months compared to sham

“While systemic immunosuppressive medications are often required for long term control of chronic non-infectious uveitis, there is still a high clinical need for local treatments which effectively target the inflamed area, minimising the effect on the rest of the body.8 This is particularly in cases where there are acute relapses, or… residual inflammation or macular oedema despite ongoing systemic therapy.”8

Uveitis accounts for about 10–15 per cent of cases of total blindness,11 and affects an estimated 1,800 Australians,7,12–14 primarily younger, working age people.11

In a single, multi centre, masked, randomised Phase 3 study involving 229 patients (the HURON trial), Ozurdex delivered rapid and significant visual gains, sustained at every time point over six months compared to sham.8 The proportion of patients with at least 15 letters improvement from baseline BCVA in the study eye at week eight was more than six-fold higher with Ozurdex (42.9 per cent) compared to sham (6.6 per cent), p<0.001.2 In a real world study of 25 patients, eyes gained an average of ~10 letters vs. baseline at three months (p=0.002), and over 2/3 of eyes did not receive further treatment after one injection of Ozurdex.15

Nine (out of 62) patients in the 0.7 mg Ozurdex cohort required cataract surgery in comparison to four (out of 55) in the sham group, although this difference was not statistically significant (p = 0.769).8 Fewer than one in 10 patients who received Ozurdex had intraocular pressure (IOP) rises ≥25 mmHg.8 IOP increases were manageable without the need for corrective surgery,8 however close monitoring and management of both of these complications (lens opacity progression and raised IOP) will be required by the clinician.2

References
1. Australian Government Department of Health (2018). Pharmaceutical Benefits Scheme. Viewed 19 February 2018. www.pbs.gov.au/pbs/home;
2. Allergan. Ozurdex Product Information;
3. National Eye Institute (NEI) (2011). Facts About Uveitis. Viewed 14 March 2018. nei.nih.gov/health/uveitis/ uveitis;
4. Better Health Channel Victoria (2017). Eyes – uveitis. Viewed 14 March 2018. www.betterhealth.vic.gov.au/health/ conditionsandtreatments/eyes-uveitis;
5. Barisani-Asenbauer T et al. Orphanet Journal of Rare Diseases. 2012; 7: 57;
6. Mayo Clinic (2015). Uveitis. Viewed 14 March 2018. www. mayoclinic.org/diseasesconditions/uveitis/symptoms-causes/ syc-20378734;
7. Rodriguez A et al. Arch Opthalmol. 1996; 114(5): 593–9;
8. Lowder C et al. Arch Opthalmol. 2011; 129(5): 545–553;
9. Pasadhika S & Rosenbaum JT. Biologics. 2014; 8: 67–81;
10. Nehme A & Edelman J. Invest Opthalmol Vis Sci. 2008; 49: 2030–8;
11. Durrani OM et al. Br J Opthalmol. 2004; 88(9): 1159–62;
12. Saari KM et al. Acta Opthalmol Scand. 1995; 73(4): 345–9;
13. Gritz DC & Wong IG. Opthalmol. 2004; 111(3): 491–500;
14. Australian Bureau of Statistics (2018). Data in pictures. Viewed 14 March 2018. www.abs.gov.au/websitedbs/D3310114.nsf/home/Home;
15. Tsang AC et al. Ocul Immunol Inflamm. 2017; 25(5): 690–697