pSivida has reported that the last patient in the phase III clinical trial being conducted by its collaborative partner, Alimera Sciences (for a new treatment for diabetic macular edema) has completed the two-year follow up visit. The phase III studies compared two doses of Iluvien with sham treatment.
Reportedly, Iluvien is an investigative, extended release intravitreal insert currently under development for the treatment of Diabetic Macular Edema (DME). Each Iluvien insert is designed to provide a sustained therapeutic effect of up to 36 months, for the low dose Iluvien, and up to 24 months, for the high dose of Iluvien.
The company said that Iluvien is inserted into a patient’s eye with a needle two thousandths of an inch in diameter, which allows for a self-sealing wound. This insertion is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists. An NDA for Iluvien is expected to be filed with the FDA in the second quarter of 2010 by Alimera.
Paul Ashton, CEO of pSivida, said: “We are very pleased that this important milestone has been achieved and we expect to see top-line 24-month data from the trial in mid-December. Assuming positive data, Alimera expects to file the NDA (New Drug Application) with the FDA in the second quarter of 2010.”