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
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
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
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
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
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
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
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.
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
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
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
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
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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