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news.pSivida, a company that develops ophthalmic sustained release drug delivery products, has received full payment of a $15m note, including an additional $225,000 in accrued interest, from Alimera Sciences, pSivida's licensee developing Iluvien for the treatment of diabetic macular edema (DME).
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pSivida’s Iluvien is an injectable, non-erodable, intravitreal implant for the treatment of DME, a potentially blinding condition that affects approximately one million people in the US.
Iluvien is designed to release the drug fluocinolone acetonide (FA) for up to periods of three years. Importantly, the device is small enough to be injected into the back of the eye with a 25 gauge needle creating a self-sealing hole. This insertion procedure is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists.
Paul Ashton, CEO of pSivida, said: “We congratulate Alimera on its successful IPO and look forward to Alimera’s filing of the NDA for Iluvien for the treatment of DME. Alimera has stated that it intends to file the NDA for Iluvien this quarter and to seek priority review, which, if granted, is expected to result in a response from the FDA in the 2010 fourth quarter.
“If the FDA approves Iluvien for the treatment of DME, pSivida is due to receive a $25m milestone payment from Alimera. pSivida would also be entitled to receive 20% of the net profits of sales of Iluvien.
“pSivida is developing other ophthalmic products, some in partnership with Pfizer, pSivida’s largest shareholder, and some internally. pSivida is also working to adapt its drug delivery platforms to deliver therapeutics outside ophthalmology.”