European regulators have given their seal of approval for Alimera Science's Iluvien, three months after their counterparts in the USA once again rejected the treatment for diabetic macular oedema.
Alimera has announced the positive outcome of the decentralised procedure for Iluvien (fluocinolone acetonide) in Europe, following a report from the reference member state, the UK's Medicines and Healthcare products Regulatory Agency. It has recommended approval for the drug for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies to Austria, France, Germany, Italy, Portugal and Spain; in these seven countries, 1.2 million people suffer from DME.
The recommendation is based on data which showed that in patients with chronic DME at month 30, after receiving the Iluvien implant, 38% of patients experienced an improvement from baseline in their best corrected visual acuity. At the completion of the 36-month study, 34% had achieved the same result. This effect was highly statistically significant as compared to the sham control group, which received laser and other intravitreally administered therapies.
Simos Simeonidis at Cowen & Co believes that the seven countries that Iluvien is expected to receive approval in account for around $200 million in peak sales. Having spoken with Alimera's management this morning, he notes that the company is examining all available options, which include both partnering and building its own European salesforce.
The good news from Europe comes as Alimera prepares to meet with the US Food and Drug Administration to discuss the agency's requirements for a third resubmission of Iluvien. In November, a second complete response letter was issued, with the FD saying Alimera's New Drug Application did not provide sufficient data to support the drug's safety and efficacy.
Mr Simeonidis said the hope would be that the agency, especially given the EU news, "may be open to re-considering the harsh requirements it imposed with the second CRL, including running two additional trials". He added that "the vast majority of retinal specialists we have consulted with believe that Iluvien should have been approved and gotten to the market already".
However, he went on to say that "barring an unexpected change in the way things are done at the FDA's Ophthalmic division, it is unfortunately, (in our view, since Iluvien works), tough to be optimistic about a reversal".