Alimera Sciences has received the backing of institutional investors to fund the commercialisation of its eye drug Iluvien which has just received marketing authorisation in France.
The US firm has entered into an agreement with a group of investors for a $40 million Series A financing and the proceeds will finance further development of Iluvien (fluocinolone acetone). The drug got its first European Union thumbs-up in Austria in April to treat vision impairment associated with chronic diabetic macular edema (DME), when the condition is unresponsive to available therapies.
The funding was announced at the same time as France's National Security Agency of Medicines and Health Products granted approval for Iluvien. The green light across the Channel 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.
The French authorisation is the fourth, preceded by Austria, Portugal and the UK. Alimera chief executive Dan Myers said the financing will provide the necessary capital to launch Iluvien in Europe, saying that "we have performed extensive market research on the market opportunity…and our findings have exceeded our initial internal expectations".
The company quoted the International Diabetes Federation which estimates that more than 4.3 million people are currently living with diabetes in France, and more than 220,500 people suffer from vision loss associated with DME.
Alimera, which licensed Iluvien from pSivida, is having a tougher time getting approval in the USA. The company has received two rejections from the US Food and Drug Administration, getting a second complete response letter in November 2011.