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pSivida Corp. (NASDAQ:PSDV), a specialty pharmaceutical company that is a leader in developing sustained release drugs for the treatment of back-of-the-eye diseases, today announced interim data from an investigator-sponsored Phase I/II study of pSivida’s injectable micro-insert in patients with posterior uveitis. The same micro-insert is being marketed in the EU as ILUVIEN® for the treatment of chronic Diabetic Macular Edema (DME) considered insufficiently responsive to available therapies by pSivida’s collaborative partner, Alimera Sciences. The uveitis application is being independently developed by pSivida.
Through the first 12 months of enrollment in this study, none of the treated eyes had a recurrence of uveitis, and inflammation had been reduced in all treated eyes. By contrast, fellow (untreated) eyes showed either recurrence of uveitis or worsening or no improvement in inflammation. At the last follow-up visit, best corrected visual acuity (on the Early Treatment Diabetic Retinopathy Study eye chart) had improved by an average of more than nine letters in treated eyes and had declined by an average of one letter in fellow eyes.
The interim data showed that the micro-inserts were well-tolerated and the observed safety profile was consistent with the short-term safety profile reported in clinical studies of ILUVIEN in DME subjects. With one exception, intraocular pressure (IOP) measurements of treated eyes had all remained in the normal range. One treated eye, which at baseline had a history of elevated IOP, required surgery to control pressure.
“We are very happy with this early data,” said Paul Ashton, Ph.D., President and CEO of pSivida Corp. “They are consistent with our hypothesis that our micro-insert will treat chronic non-infectious uveitis affecting the back of the eye with an efficacy profile that is comparable to Retisert, a current FDA- approved implant for uveitis developed by pSivida, and a side effect profile that is superior to Retisert and comparable to ILUVIEN in DME,” said Dr. Ashton.