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OZURDEX (dexamethasone) (OMD)

Opinions on drugs - Posted on Sep 30 2021

Reason for request

Reevaluation

Key points

Favourable opinion for reimbursement only in the treatment of visual impairment due to diabetic macular oedema (DME) in adults with a visual acuity of less than or equal to 5/10 and in whom diabetes management has been optimised, in patients who are:

  • pseudophakic,
  • considered insufficiently responsive to non-corticosteroid therapy,
  • or considered unsuitable for non-corticosteroid therapy.

Unfavourable opinion for reimbursement in other situations.

What therapeutic improvement?

No clinical added value in the therapeutic strategy.

Role in the care pathway?

Optimisation of diabetes management and its risk factors (glucose, blood pressure and lipid balance and quitting smoking) is a prerequisite to any treatment for visual impairment due to diabetic macular oedema (DME). Control of blood glucose and blood pressure, within the limits required by learned societies, can make it possible to control progression of the retinopathy or DME.

Among the other types of management available, focal laser photocoagulation, which is the standard treatment, is reserved for focal forms of macular oedema located away from the fovea, and possibly cases of severe DME involving the central region, where there are leaks from micro-aneurysms accessible via laser treatment and when visual acuity is normal. This technique does not improve visual acuity.

Medicinal treatments include anti-VEGF intravitreal injections (ranibizumab and aflibercept) and corticosteroid intravitreal implants [OZURDEX (dexamethasone) and ILUVIEN, (fluocinolone acetonide)].

Anti-VEGF [ranibizumab (LUCENTIS) and aflibercept (EYLEA)] intravitreal injections are first-line treatments when the visual impairment is associated with a diffuse form of DME or leakages close to the centre of the macula.

The MA for OZURDEX (dexamethasone) limits its use, firstly, to patients who are pseudophakic or who are unsuitable for non-corticosteroid therapy - subpopulations in which it is considered to be a first-line treatment - and, secondly, to patients insufficiently responsive to non-corticosteroid therapy, i.e. as second-line treatment.

For anti-VEGF therapies, as for OZURDEX (dexamethasone), the Committee recommends that these treatments be used when visual acuity has decreased to less than or equal to 5/10 and diabetes management has been optimised.

The choice between anti-VEGF therapies [ranibizumab (LUCENTIS) and aflibercept (EYLEA)] and OZURDEX (dexamethasone) in pseudophakic patients is left to the decision of the ophthalmologist, who should take into account the ophthalmological characteristics of the treated eye, the diabetic retinopathy stage, as well as the patient’s cardiovascular and cerebrovascular history and capacities to comply with treatment.

In chronic DME, a fluocinolone acetonide intravitreal implant (ILUVIEN) is a therapeutic option, in the event of failure of other treatments, particularly anti-VEGF therapies, OZURDEX (dexamethasone) and laser therapy, if management of diabetes is optimised, taking into account its safety profile (risk of glaucoma, cataract).

DME associated with vitreomacular traction is the only clinical form for which surgery remains the treatment of choice. This form of DME is rare: it is estimated to concern less than 5% of oedemas.

Role of OZURDEX (dexamethasone) in the care pathway

OZURDEX (dexamethasone) has a role in the treatment of visual impairment due to diabetic macular oedema when visual acuity is less than or equal to 5/10 and diabetes management has been optimised, in the following situations:

  • as first-line treatment in patients who are pseudophakic or who are considered unsuitable for non-corticosteroid therapy,
  • as second-line treatment in patients who are considered insufficiently responsive to non-corticosteroid therapy.

The choice between anti-VEGF therapies [ranibizumab (LUCENTIS) and aflibercept (EYLEA)] and OZURDEX (dexamethasone intravitreal implant) in the first-line treatment of pseudophakic patients is left to the decision of the ophthalmologist, who should take into account the ophthalmological characteristics of the treated eye [history of glaucoma or ocular hypertonia, lens status (phakic or pseudophakic), history of vitrectomy], the diabetic retinopathy stage, as well as the patient’s cardiovascular and cerebrovascular history, age and capacities to comply with treatment.

 


Clinical Benefit

Moderate

The Committee deems that the clinical benefit of OZURDEX (dexamethasone) 700 micrograms intravitreal implant in applicator remains moderate in the treatment of visual impairment due to diabetic macular oedema (DME) in adults with a visual acuity of less than or equal to 5/10 and in whom diabetes management has been optimised, in patients who are:

  • pseudophakic,
  • considered insufficiently responsive to non-corticosteroid therapy,
  • or considered unsuitable for non-corticosteroid therapy.
Insufficient

It remains insufficient in the other situations.


Clinical Added Value

no clinical added value

 Considering:

  • the low improvement in visual acuity, below the clinical relevance threshold, observed with OZURDEX (dexamethasone) in the MEAD 010 and 011 randomised, single-blind placebo-controlled studies and in the LOUVRE 3 observational study that was discontinued prematurely;
  • the specific adverse reaction risks associated with the administration of an intraocular corticosteroid and observed with OZURDEX (dexamethasone), such as increased intraocular pressure, cataract and conjunctival haemorrhage;
  • the absence of randomised comparative studies having compared the efficacy and safety of OZURDEX (dexamethasone) with those of anti-VEGF therapies (ranibizumab and aflibercept) in the medium and long term;
  • the absence of a demonstrated improvement in terms of quality of life compared to anti-VEGF therapies;

the Committee considers that OZURDEX (dexamethasone) provides no clinical added value (CAV V) in the care pathway, including, in particular the anti-VEGF therapies LUCENTIS (ranibizumab) and EYLEA (aflibercept), for visual impairment due to DME in adults when visual acuity is less than or equal to 5/10 and diabetes management has been optimised.


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