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Implant for chronic diabetic macular edema approved in six European countries

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ILUVIENR, a sustained release corticosteroid intravitreal implant for treating chronic diabetic macular edema (DME) that is insufficiently responsive to other therapies has been approved for marketing in six European countries. ILUVIEN (190 micrograms fluocinolone acetonide, or FAc, insert in applicator) has been launched by Alimera Sciences, a biopharmaceutical company specialising in the research, development and commercialisation of prescription ophthalmic pharmaceuticals, headquartered in Alpharetta, Georgia, US.

Injected with a 25-gauge needle through a self-sealing wound, ILUVIEN delivers a sub-microgram dose of FAc in the eye, providing an anti-inflammatory effect for up to 36 months, said Dr Philip Ashman, Alimera’s senior vice-president and EU managing director. It is intended for patients with chronic DME who respond insufficiently despite available treatments such as laser photocoagulation or anti- VEGF treatment, he added.

In two Phase 3 clinical trials, known together as FAME, 34 per cent of patients that were treated with ILUVIEN who had chronic DME at study entry gained 15 or more letters of best corrected visual acuity at 36 months. The improvement was statistically significant (p<0.001) compared with the 13.4 per cent seen in the control group, receiving standard of care, which included use of laser and other intravitreal therapies (IVTA and anti-VEGF antibody treatments). These therapies were prescribed by a masked, assessing retina specialist.

ILUVIEN is now available in Germany and the UK. Marketing authorisations have been granted in Austria, France, Portugal and Spain, and is pending in Italy, though the drug is not yet commercially available in those markets. Even so, ophthalmologists across the continent are enthusiastic about the introduction of ILUVIEN, which offers hope for preserving or improving vision in patients with no other real options for halting advanced DME, Dr Ashman said. “It is very evident from our day-to-day interactions that ILUVIEN meets a real need for many patients and demand is building.”

Indications and payment

In support of ILUVIEN’s launch, Alimera has deployed teams across Europe that provide ophthalmologists with information, answer questions and give instructions for inserting the implant, Dr Ashman said. A model eye is used to help surgeons get a feel for using the applicator. “It works very well and we have had great feedback.”

As with many new technologies, though, obtaining reimbursement is a challenge, Dr Ashman said. Even though six countries have granted ILUVIEN national licenses through a marketing authorisation process led by the UK Medicines and Healthcare products Regulatory Agency, achieving universal reimbursement within a country such as Germany, the UK or France is another matter.

For example, in Germany, privately insured and self-pay patients had access to ILUVIEN from the day it became commercially available. In contrast, patients using statutory health insurance are typically dealt with on a case-by-case basis until reimbursement contracts are in place, Dr Ashman said. History shows that achieving inclusion of new ophthalmology products in reimbursement contracts can take a number of months, however, the process of contracting is well established and Dr Ashman is optimistic about progress. “It is in everyone’s interests to get contracts in place to enable patients to get the treatment they need.”

In the UK, privately insured and self-pay patients have also had access from the day ILUVIEN was made commercially available, and recent events suggest that coverage through the National Health Service appears likely for a subgroup of patients in the near future. In June, a UK National Institute for Health and Care Excellence advisory panel recommended coverage for pseudophakic, but not phakic, patients with chronic DME insufficiently responsive to available therapy. The ruling reversed a January recommendation that ILUVIEN not be approved because it did not meet NHS costeffectiveness standards.

The subgroup was proposed by Alimera, supported by a simplified patient access scheme, or PAS, designed to address the cost-effectiveness issues noted in NICE’s original guidance on ILUVIEN, Dr Ashman said. “We have provided the NHS the opportunity of a simple scheme, not dissimilar to others that have worked well.”

While ILUVIEN demonstrated a protective effect on subjects with chronic DME undergoing cataract surgery, narrowing ILUVIEN coverage to pseudophakic patients removes the financial impact of accelerated cataract formation that was seen in the FAME studies. Of the chronic DME patients who were phakic at the start of the FAME trials, 80 per cent of those in the ILUVIEN group developed cataracts and 75 per cent had cataract surgery, compared with 45 per cent and 23 per cent respectively for the control group at 24 months. At 36 months, 85 per cent of them had cataract surgery compared with about half in the control group.

In France, the transparency commission of the French National Health Authority issued an opinion favoring ILUVIEN for National reimbursement. Alimera is now working with the economic committee to determine the price and any reimbursement conditions. Dr Ashman expects a final coverage decision by year’s end.

While ILUVIEN has achieved approval in six European countries, the evaluation of the registration dossier continues in the US. The approval of ILUVIEN by the EU Health Authorities demonstrates that, in terms of benefit to risk ratio, the discovery of the significant and reproducible treatment effect of ILUVIEN in the chronic DME population offsets the known steroid classeffects of cataract formation and elevation of IOP. These Health Authorities reviewed the same dossier and information that has been submitted in the US. “ILUVIEN is not a therapy for the treatment of naive patients, but is positioned in the treatment algorithm in accordance with the label, where available therapies are not providing sufficient benefit,” Dr Ashman said. “We continue to work with the US FDA and hope they will approve the use of ILUVIEN in patients with chronic DME in the US.”

Alimera expects to further expand operations in Europe in 2014, Dr Ashman said. He expects growing demand for ILUVIEN as the burden of diabetes continues to increase and more patients develop chronic DME. “ILUVIEN offers a sight-saving option for a group of patients who do not gain sufficient response from available therapies. We believe it will bring benefit to very many patients in the future.” Trials of ILUVIEN are under way in other indications, including dry age-related macular edema and retinal vein occlusion. Alimera also is investigating NADPH oxidase inhibitors to treat dry AMD. 

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