The US Food and Drug Administration (FDA) has approved pSivida's investigational new drug (IND) application for injectable sustained-release micro-insert, designed as a treatment for posterior uveitis.
pSivida's injectable micro-insert, which features a tiny tube about the size of an eyelash, is injected with a fine gauge needle to release the off-patent steroid fluocinolone acetonide at a consistent rate over a period of approximately 36 months.
The approval permits pSivida to conduct two Phase III trials to treat patients with posterior uveitis, without the need of Phase I or Phase II trials.
pSivida said the Phase III trials, which will enroll a total of 300 patients, would be in addition to the investigator-sponsored trial studying the same device for posterior uveitis.
pSivida president and CEO Paul Ashton said importantly, the FDA has agreed that the primary end point in these trials will be recurrence of uveitis within 12 months and that the company can reference much of the data, including the clinical safety data, from the clinical trials for ILUVIEN for diabetic macular edema conducted by its collaborative partner Alimera Sciences.
"We appreciate the input provided by the FDA about the design of these trials and believe these design features will be advantageous in terms of cost and time," Ashton added.
"Because the micro-insert delivers the same drug as our approved Retisert product for posterior uveitis, we expect to these trials will show efficacy.
"Further, as the same micro-insert was used in the ILUVIEN trials, we expect to observe a comparable side-effect profile in uveitis patients as was seen in DME patients."
