US biopharmaceutical group Alimera will be celebrating news that its eye implant Iluvien has received its first marketing approval in Austria.
Shares in the group rocketed nearly 30% on the Nasdaq yesterday (Tuesday) after the Austrian Agency for Health and Food Safety granted Iluvien (fluocinolone acetonide) marketing authorisation to treat vision impairment associated with chronic diabetic macular edema (DME), when the condition is unresponsive to available therapies.
The move follows a positive outcome in the decentralised procedure in Europe, following a report by reference member state the UK, which recommended the drug as a safe and effective treatment to concerned member states Austria, France, Germany, Italy, Spain and Portugal earlier this year.
Iluvien is essentially a sustained release intravitreal implant that delivers tiny levels of active substance fluocinolone acetonide for up to 36 months to treat of chronic DME.
In clinical trials, 38% of patients with chronic DME at month 30 experienced a significant improvement in visual acquity after receiving Iluvien, and at completion of the 36-month study, 34% had achieved the same result, a highly statistically significant result compared to the control group, which received laser and other intravitreally administered therapies.
Commenting on the approval, Michael Stur, professor at the Medical University of Vienna, said it will offer chronic DME patients who are unresponsive to current therapies “another chance to maintain their vision”, and that the availability of Iluvien will “be beneficial in the long-term management of their condition”.
The company said it expects additional marketing authorisations in the coming months in CMS, which analysts at Cowen & Co expect will account for around $200 million in peak sales.
Sales in house or partnered?
The question now is how Alimera will sell its product now it has marketing approval. As Cowen & Co analyst Simos Simeonidis notes, Alimera's founder, president and chief executive Dan Myers now has to decide whether to keep Iluvien in house and build an EU salesforce, sign up a marketing partner for the drug, or even sell the group itself.
Across the Atlantic things are looking somewhat shakier for Iluvien. The company has already received two rejections from the US Food and Drug Administration after a second complete response letter was issued in November 2011, and Alimera is currently in discussions with the regulator over a third submission for the product.