These frequently asked questions are designed to help you understand more about OZURDEX®
Mechanism of action
Inflammation plays a significant role in the multifactorial pathogenesis of DME.1-4
Hyperglycemia triggers biochemical pathways which increase inflammation in the eye through the release of pro-inflammatory mediators.1,2 These include ICAM-1, IL-1β, IL-6, MCP-1, TNF-α and VEGF.1,2
These inflammatory mediators contribute to the breakdown of the blood retinal barrier, leading to excess fluids and lipids accumulating in the macula.1,2 This can result in foveal edema and lead to vision loss.1,2
When treating DME, factors to consider include, but are not limited to, both the inflammatory and vascular nature of the disease.1-4
Understanding of the multiple factors involved in the pathophysiology of DME continues to advance.
Find out more about OZURDEX®’s anti-inflammatory mechanism of action
OZURDEX® is a corticosteroid shown to suppress inflammation with a broad mechanism of action.*5-9
Dexamethasone has been shown to suppress inflammatory mediators significant in the pathogenesis of DME (including ICAM-1, IL-1β, IL-6, MCP-1 and TNF-α), as well as suppressing the breakdown of the blood retinal barrier.*1,2,5-9 In addition, corticosteroids have been shown to inhibit the expression of VEGF.5
In summary, OZURDEX® has been shown to reduce DME through anti-inflammatory effects, vascular effects and by activating draining mechanisms.*5-9
*Supporting evidence includes data from animal models
Dexamethasone has been shown to suppress at least five pro-inflammatory mediators significant to the pathogenesis of DME (ICAM-1, IL-1β, IL-6, MCP-1 and TNF-α).*1,2,5-9 In addition, corticosteroids have been shown to inhibit the expression of VEGF.5
In summary, OZURDEX® has been shown to reduce DME through anti-inflammatory effects, vascular effects and by activating draining mechanisms.*5-9
*Supporting evidence includes data from animal models
Patient selection
OZURDEX® is indicated for the treatment of adult patients with visual impairment due to DME who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.5
OZURDEX® can provide suitable patients with vision gains with a light injection schedule5,10 and a broad mechanism of action, suppressing inflammatory mediators significant to the pathogenesis of DME.*1,2,5-9
*Supporting evidence includes data from animal models.
Find out more about OZURDEX® real world data
Find out more about OZURDEX® pivotal data
Find out more about OZURDEX®’s mechanism of action
Real world evidence is collected outside of controlled clinical trials and has inherent limitations including a lesser ability to control for confounding factors. Robust conclusions cannot be made in the absence of head-to-head clinical trials.
OZURDEX® is indicated for the treatment of adult patients with visual impairment due to DME who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.5
When considering treatment-naïve patients, OZURDEX® may be suitable first line for patients who are pseudophakic or considered suitable for first line corticosteroid therapies.5
The EURETINA guidelines for the management of DME state that patients who might be suitable for first line corticosteroid therapies include patients who are unwilling to attend monthly injection appointments in the first 6 months, as well as patients with a previous major cardiovascular event, as these patients were excluded from all major anti-VEGF trials.11 OZURDEX® may help reduce treatment burden for these patients with its light injection schedule, retreatment may be performed after approximately 6 months and OZURDEX® has no loading dose.5 Regular monitoring of IOP is required with OZURDEX®.5
OZURDEX® achieved vision gains in treatment-naïve patients in clinical and real world studies.10,12 In the pivotal MEAD study (n=351), 22.2% of patients, including those who were treatment-naïve (n=104), achieved ≥15-letter improvement in BCVA from baseline to year 3 or final visit (p<0.001 vs sham, n=350 where 12% of patients achieved ≥15-letter improvement in BCVA).10 In a real world study, suitable treatment-naïve patients (n=176) achieved a mean of 12 letters with 1.9 injections over a 10.8 month follow-up with OZURDEX®.12
Find out more about OZURDEX® real world data
Find out more about OZURDEX® pivotal data
Real world evidence is collected outside of controlled clinical trials and has inherent limitations including a lesser ability to control for confounding factors. Robust conclusions cannot be made in the absence of head-to-head clinical trials.
Boyer D et al. 2014. Data from the pivotal MEAD study included two randomised, multicentre, masked sham-controlled, phase 3 trials with identical protocols conducted to evaluate the safety and efficacy of OZURDEX® in the treatment of patients with DME. 1,048 patients were randomised 1:1:1 to study treatment with OZURDEX® 0.7 mg (n=351), dexamethasone implant 0.35 mg (n=347, this dose is not commercially available) and sham (n=350). Patients were followed for three years (or 39 months for patients treated at Month 36) at ≤40 scheduled visits. The primary endpoint was ≥15 letters improvement in BCVA from baseline. The results were pooled for analysis. The primary endpoint was achieved by 22.2% of OZURDEX® patients (p<0.001). Rates of cataract-related AEs in phakic eyes were 67.9% with OZURDEX®. Increases in IOP were usually controlled with medication or no therapy; only one patient (0.3%) treated with OZURDEX® required trabeculectomy due to steroid-induced IOP increase.10
Kodjikian L et al. 2018. Data from a PubMed literature search on February 1, 2018 including 63 observational studies about the management of DME with OZURDEX® (31 studies including 1,703 eyes) and anti-VEGF (32 studies including 6,842 eyes). Only studies including more than 10 patients with a duration of more than six months were included. Analyses were carried out on the overall population and on subgroups to show real world efficacy outcomes and number of intravitreal injections (IVIs). Limitations of this meta-analysis include varying n numbers, definitions of visual acuity (VA) being different among some of the anti-VEGF and OZURDEX® implant studies, and difference in the proportion of suitable naïve eyes treated with OZURDEX® (1/5 of eyes were treatment-naïve) and those treated with anti-VEGFs (2/3 of eyes were treatment-naïve).12
OZURDEX® is indicated for the treatment of adult patients with visual impairment due to DME who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.5
When considering treatment refractory patients, OZURDEX® may be suitable second line for patients who are considered insufficiently responsive to non-corticosteroid therapy.5
OZURDEX® achieved vision gains in refractory patients in clinical and real world studies.10,12 In the pivotal MEAD study (n=351), 22.2% of patients, including those who were refractory (n=247), achieved ≥15-letter improvement in BCVA from baseline to year 3 or final visit (p<0.001 vs sham, n=350 where 12% of patients achieved ≥15-letter improvement in BCVA).10
In a real world study (n=69), patients with an early switch to OZURDEX® (n=31, after an insufficient response to 3 anti-VEGF IVIs) were shown to achieve significant vision gains and significant reduction in central subfoveal thickness (CST). These patients achieved a median increase in BCVA of 0.2 decimal acuity, p=0.0043 and a median change in CST of -116 μm (p=0.0002). However, patients switched late (n=38, after an insufficient response to ≥6 anti-VEGF IVIs) did not achieve significant vision gains, p=0.8602. These patients achieved a median change in CST of -77 μm (p=0.0038). An inadequate response to anti-VEGF was defined in this study as a reduction in CST or total macular volume (TMV) <10% and/or a BCVA improvement <0.1 (decimal scale).*13
Find out more about OZURDEX® real world data
Find out more about OZURDEX® pivotal data
*A decimal VA improvement from 0.2 to 0.4 would be equivalent to a Snellen VA improvement of 20/100 to 20/50 or a LogMAR VA improvement of 0.7 to 0.4.
Real world evidence is collected outside of controlled clinical trials and has inherent limitations including a lesser ability to control for confounding factors. Robust conclusions cannot be made in the absence of head-to-head clinical trials.
Boyer D et al. 2014. Data from the pivotal MEAD study included two randomised, multicentre, masked sham-controlled, phase 3 trials with identical protocols conducted to evaluate the safety and efficacy of OZURDEX® in the treatment of patients with DME. 1,048 patients were randomised 1:1:1 to study treatment with OZURDEX® 0.7 mg (n=351), dexamethasone implant 0.35 mg (n=347, this dose is not commercially available) and sham (n=350). Patients were followed for three years (or 39 months for patients treated at Month 36) at ≤40 scheduled visits. The primary endpoint was ≥15 letters improvement in BCVA from baseline. The results were pooled for analysis. The primary endpoint was achieved by 22.2% of OZURDEX® patients (p<0.001). Rates of cataract-related AEs in phakic eyes were 67.9% with OZURDEX®. Increases in IOP were usually controlled with medication or no therapy; only one patient (0.3%) treated with OZURDEX® required trabeculectomy due to steroid-induced IOP increase.10
Hernández Martínez A et al. 2020. A retrospective and single-centre study of 69 eyes (31 early switch; 38 late switch) treated in an ophthalmology centre in Spain, comparing the results of early (after 3 IVIs) versus late switch (after ≥6 IVIs) to OZURDEX® in patients with DME who had an insufficient response to anti-VEGFs. Three (9.7%) and 10 (26.3%) eyes have developed ocular hypertension over the course of the follow up in the early and late switch groups respectively.13
OZURDEX® is indicated for the treatment of adult patients with visual impairment due to DME who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.5
When considering phakic patients, OZURDEX® may be suitable for patients who are considered insufficiently responsive to or unsuitable for non-corticosteroid therapies.5
Yes, OZURDEX® is indicated for the treatment of adult patients with:5
• Visual impairment due to DME who are pseudophakic or who are considered insuffciently responsive to, or unsuitable for non-corticosteroid therapy
• Macular edema following either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
• Inflammation of the posterior segment of the eye presenting as non-infectious uveitis
Injection schedule
OZURDEX® provides sustained release of dexamethasone.5 The retreatment interval for DME is after approximately 6 months with no loading dose.5 Regular monitoring of IOP is required with OZURDEX®.5 This light injection schedule may be a benefit to patients who may struggle to fit DME appointments into their already busy lives.11,14
Living with DME can be a burden to patients. In addition to managing their diabetes, DME patients may suffer from a number of other diabetic-related comorbidities and consequently may have multiple regular hospital appointments.14-16 They are often of working age so may struggle to balance their appointments with busy work and family lives.15,16 One study showed patients desire fewer injections and appointments to achieve the same visual results.14 This shows patients don’t want to compromise on treatment outcomes, but would like to reduce treatment burden.14
OZURDEX®’s retreatment interval in DME is after approximately 6 months with no loading dose.5 This injection schedule means OZURDEX® may help to alleviate DME patients’ treatment burden.14-16 This is recognised by EURETINA guidelines which state ‘corticosteroids may be considered as a first line therapy [in] patients who are not willing to come for monthly injections and/or monitoring in the first 6 months of therapy, however these patients’ IOP still needs to be monitored’. Of the steroids, ‘dexamethasone shall be used first.’11
Sivaprasad S & Oyetunde S 2016. 131 retinal patients (86 DME; 45 RVO) from Germany, Italy and the UK completed a detailed questionnaire about the impact of injection therapy on quality of life. This survey aimed to understand treatment burden, treatment-related anxiety and worry, and practical issues such as appointment attendance and work absence in patients receiving injection therapy for DME or RVO.14
OZURDEX® should be administered under controlled aseptic conditions. The following equipment (or equivalent) is needed for the OZURDEX® injection procedure: topical antiseptic, local anaesthesia, OZURDEX® applicator, sterile gloves, sterile eyelid speculum, sterile cotton bud and sterile drape.5
The OZURDEX® procedure is similar to other intravitreal injections however, it has a lighter injection schedule than anti-VEGFs.5,17-20
OZURDEX®’s NOVADUR® technology provides sustained release of dexamethasone via a biodegradable implant.21 The retreatment interval in DME is after approximately 6 months with no loading dose.5 Regular monitoring of IOP is required with OZURDEX®.5 This light injection schedule may benefit patients and clinicians as it helps reduce DME treatment burden and may improve adherence.14-16
Safety
OZURDEX® has a predictable and manageable safety profile.5,10 As expected with ocular steroid treatment and intravitreal injections, increases in IOP may be seen.5 Use of corticosteroids may also induce the development of cataracts.5,10,22
Intraocular pressure
IOP rises are typically transient and normally manageable with IOP-lowering medication, but regular monitoring is required.5,23 The incidence or magnitude of IOP elevation has been shown not to increase upon repeated injection over 3 years.10
In the pivotal MEAD study, 41.5% of patients (n=144/347) required IOP-lowering medications in the study eye at some stage during the 3 year study. Only 1 patient (0.3%) required a trabeculectomy due to a steroid-induced IOP rise.10
Cataracts
It should be remembered that patients with diabetes are more likely to develop cataracts - one retrospective, observational study in newly diagnosed diabetes patients (n=56,510) showed an approximate 2-fold increase compared to the general population.24 In the pivotal MEAD study, 87.0% of patients with a phakic study eye treated with OZURDEX® had some degree of lens opacification/early cataracts at baseline.5 The rate of cataract-related adverse events (including cataract cortical, cataract diabetic, cataract nuclear, cataract subcapsular, cataract lenticular and cataract) was 67.9% in phakic patients.5,10 Improvement in vision from baseline was restored after cataract surgery and by end of study, treatment with OZURDEX® resulted in improvement in BCVA independent of the lens status at baseline.10
When treating a sight-threatening disease like DME10 a suitable balance between safety and vision gains should be achieved.25
Find out about OZURDEX®’s safety profile
Abbreviations and references
BCVA, best corrected visual acuity; CRT, central retinal thickness; DME, diabetic macular edema; ICAM-1, intercellular adhesion molecule 1; IL-1β, interleukin 1 beta; IL-6, interleukin 6; IOP, intraocular pressure; IVI, intravitreal injection; MCP-1, monocyte chemoattractant protein 1; TNF-α, tumour necrosis factor alfa; VEGF, vascular endothelial growth factor.
1. Bahrami B et al. Diabetologia 2016; 59: 1594-608.
2. Urias E et al. Vision Research 2017; 139: 221-7.
3. Munk M et al. Int J Mol Sci 2022; 23: 7585.
4. Noma H et al. Int J Mol Sci 2021; 22: 3427.
5. OZURDEX® SPC.
6. Nehmé A and J Edelman. Invest Ophthalmol Vis Sci 2008; 49(5): 2030-8.
7. García-Layana A et al. Ophthalmologica 2018; 240(2): 61-72.
8. Siqueiros-Marquez L et al. Invest Ophthalmol Vis Sci 2017; 58: 876-86.
9. Wang K et al. Biol Pharm Bull 2008; 31(8): 1541-6.
10. Boyer D et al. Ophthalmology 2014; 121(10): 1904-14.
11. Schmidt-Erfurth U et al. Ophthalmologica 2017; 237(4): 185-222.
12. Kodjikian L et al. BioMed Research International 2018. https://doi.org10.1155/2018/8289253.
13. Hernández Martínez A et al. Eur J Ophthalmol 2020; 30(5): 1091-8.
14. Sivaprasad S and Oyetunde S. Clin Ophthalmol 2016; 24(10): 939-46.
15. Rose MA et al. Clin Exp Ophthalmol 2020; 48(9): 1286-98.
16. Kiss S et al. Clin Ophthalmol 2016; 10: 2443.
17. Lucentis SPC.
18. Eylea SPC.
19. Beovu SPC.
20. Vabysmo SPC.
21. Haghjou N et al. J Ophthalmic Vis Res 2011; 6(4): 317-29.
22. Sampat K et al. Curr Opin Ophthalmol 2010; 21: 178-83.
23. Malcles A et al. Retina 2017; 37(7): 1352-9.
24. Becker C et al. Eye 2018; 32(6): 1028-35.
25. Udaondo P et al. Clin Ophthalmol 2021; 15: 3183-95.
Job Number ALL-OZU-220126. Date of Preparation April 2023
OZURDEX® (dexamethasone intravitreal implant) is indicated for the treatment of adult patients with:
- Visual impairment due to diabetic macular edema (DME) who are pseudophakic or who are considered insufficiently
responsive to, or unsuitable for non-corticosteroid therapy - Macular edema following either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
- Inflammation of the posterior segment of the eye presenting as non-infectious uveitis
Adverse events should be reported. Reporting forms and information can be found at XXXX
Adverse events should also be reported to AbbVie on GVPV@abbvie.com
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Job Number ALL-OZU-220126. Date of Preparation April 2023. This website has been developed and funded by AbbVie Ltd.
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