There's an adage that says "eyes are the windows to the soul". But to medical researchers, eyes are windows to health because some diseases could be detected just by looking at our eyes. For example, changes in the eye's retinal vessels offer early clues in detecting diabetic retinopathy. If left untreated, diabetic retinopathy can cause vision loss in two ways namely, by proliferative retinopathy and by diabetic macular edema.
Diabetic macular edema, or DME, is the major cause of vision loss in people with diabetic retinopathy. A treatment for DME, recently approved in Austria and with additional expected EU approvals, is Iluvien, being developed by Alimera Sciences Inc. (ALIM).
For readers who are new to Alimera, here's brief overview of the company and the upcoming events to watch out for...
The company's most advanced product is Iluvien, which is a sustained release non-erodable, intravitreal implant. Alimera licensed the product from pSivida Corp. (PSDV) in 2005.
Alimera made registration filings seeking approval for Iluvien in the United Kingdom, Austria, France, Germany, Italy, Portugal and Spain in July 2010. In February of this year, Iluvien received a favorable conclusion deeming it approvable in Europe.
Last week, Iluvien was approved in Austria, which marked the first national approval in the EU. Approvals in the six other EU member states are expected in the coming months. The commercialization plans for Iluvien in the EU are underway, according to the company.
The company estimates that approximately 1.1 million suffer from DME in the EU countries in which Iluvien has been recommended for marketing authorization and Austria, where it has already been approved.
However, in the U.S., Alimera has not been lucky so far in its tryst with the regulatory agency. The company, which has twice received a complete response letter for Iluvien - once in December of 2010 and again in November of 2011, plans to meet with the FDA during this quarter to discuss about its approval process.
In its complete response letter issued for Iluvien last November, the FDA had asked Alimera to conduct two additional clinical trials to demonstrate that the product is safe and effective for the proposed indication of diabetic macular edema.
There is no ophthalmic drug therapy currently approved by the FDA for the treatment of DME in the U.S. The only FDA approved method for treating DME involves laser photocoagulation therapy, which can leave irreversible blind spots. It is estimated that more than one million people in the United States alone are affected by DME.
The FDA-approved wet AMD treatment Lucentis of Roche Group's Genentech is under FDA review as a potential treatment of DME. Last year, Lucentis was approved for treatment of visual impairment due to DME in Europe.
Iluvien is also being studied in three phase II clinical trials for the treatment of the dry form of age-related macular degeneration, the wet form of AMD and retinal vein occlusion.
Alimera is not currently generating revenues. According to the company, in the near term its ability to generate revenues will depend solely on the successful commercialization of Iluvien in Austria where it has been approved, and six other EU countries in which it has been recommended for marketing authorization.
As of December 31, 2011, the company had an accumulated net deficit of $211.4 million and cash of $33.6 million.
The company is scheduled to release its first quarter fiscal year 2012 financial results before the market opens on Friday, May 11.
Over the past one year, ALIM has traded in a range of $1.09 to $9.28. The stock closed Friday's trading at $3.23.
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