pSivida Corp. (NSDQ:PSDV) licensee Alimera Sciences (NSDQ:ALIM) submitted a Marketing Authorization Application in several European Union countries for Iluvien, an ophthalmic drug/device combination.
Iluvien is a sustained release drug delivery system that delivers flucocinolone acetonide, a steroid for the treatment of diabetic macular edema.
Watertown, Mass.-based pSivida said Alimera submitted applications for pSivida’s Iluvien technology in the United Kingdom, Austria, France, Germany, Italy, Portugal and Spain.
The companies also filed a new drug application for Iluvien with the Food & Drug Administration for Illuvien in June.
Iluvien is the company’s third product aimed at back-of-the-eye diseases. The first two products won FDA approval and are on the market, according to pSivida president and CEO Paul Ashton. They are Retisert, for the treatment of posterior uveitis, and Vitrasert, for the treatment of AIDS-related cytomegalovirus retinitis. Both are licensed to Bausch & Lomb Inc.
There are currently no approved drugs to treat DME, Ashton said. The company is also working on a treatment for retinitis pigmentosa, which involves the gradual deterioration of the rods and cones that make up the retina. In April Ashton told MassDevice that its Durasert device also uses flucocinolone acetonide, a steroid, to treat the disease.
pSivida’s partnership with Alimera has already begun paying off, thanks to a $15.3 million payment triggered by Alimera’s initial public offering in April. At the time Ashton told us pSivida planned to use the cash to further develop its product pipeline. If the FDA gives the nod to Iluvien, it would trigger another, $25 million payment from Alimera, plus 20 percent royalties on net profits from sales of the treatment.
That good news overshadowed pSivida’s $2.7 million net loss for the quarter ending March 31. The company’s revenues shrank following a contract expiration with a product-development partner in December.
