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European authorities recommend marketing extension for Ozurdex
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The European Union’s Committee for Medicinal Products for Human Use has recommended extending the marketing authorization for the dexamethasone 700 mcg intravitreal implant in applicator, according to an Allergan press release.
Dexamethasone 700 mcg intravitreal implant (Ozurdex, Allergan) is indicated for adult patients with vision loss due to diabetic macular edema who are pseudophakic, or who are unable to undergo non-corticosteroid therapy.
The implant is already approved across the E.U. for the treatment of macular edema in patients with retinal vein occlusion, as well as for posterior segment inflammation characterized as non-infectious uveitis.
The committee’s final decision is expected within a few months, according to the press release.
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Albert J. Augustin, MD
DME is a sight threatening condition. Diabetes and diabetic retinopathy lead to an upregulation of numerous inflammatory pathways. Therefore, antagonizing those pathways is a reasonable and more causal approach than an antiedematous strategy. We are glad that we have now with Ozurdex an approved anti-inflammatory agent in our armentarium to treat our patients.
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Anat Loewenstein, MD
The retina specialist community is thrilled at the approval of Ozurdex for the treatment of diabetic macular edema in patients who are pseudophakic, or considered insufficiently responsive to, or unsuitable for anti VEGF therapy. We know that diabetic macular edema results from increase is permeability of retinal blood vessels in the retina of the diabetic patient. This increase is not modulated at least partly by inflammatory agents and thus logically amenable to therapy with steroids.
From our daily practice we know that many patients with diabetic macular edema are not sufficiently responsive to other therapies such as anti-VEGF and or laser. From the experience gained so far both from the trials and from approved off label use, these patients may respond nicely to intravitreal steroids, namely to Ozurdex.
Also, the safety proflie of steroid therapy is excellent from the systemic point of view, making this therapy particularly suitable to patients who are in risk for cardiovascular event. The ocular safety is also very good, particularly in patients who are already pseudophakic.Perspective
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Jean-François Korobelnik, MD
CHMP approval is great news for the patients with clinically significant DME, as it provides a potent alternative to anti-VEGF agents, while reducing the burden of the treatment. It will be a first line treatment for pseudophakic eyes, and will be quickly adopted by the physicians, based on their experience with Ozurdex in the treatment of RVO related macular edema.
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Paolo Lanzetta, MD
This is very positive news! Diabetic macular edema remains one the major causes of visual loss despite the recent advancements in the therapeutic armamentarium. After the registration of the anti-VEGF drug ranibizumab and the possibility to have aflibercept licensed for this disease soon, physician have the chance to treat diabetic macular edema with the approved dexamethasone implant. Many of us have already gained significant experience with this new steroidal drug in this condition and can confirm its efficacy and safety. Diabetic macular edema is associated with chronic inflammatory cytokines in the retinal microenvironment and dexamethasone may address multiple steps in the inflammatory pathogenic cascade.
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