The FDA has cleared pSivida Corp.’s Investigational New Drug application to treat posterior uveitis with an injectable sustained-release fluocinolone acetonide micro-insert, which releases fluocinolone acetonide at a consistent rate over a period of approximately 36 months.
Watertown, MA-The FDA has cleared pSivida Corp.’s Investigational New Drug application to treat posterior uveitis with an injectable sustained-release fluocinolone acetonide micro-insert, which releases fluocinolone acetonide at a consistent rate over a period of approximately 36 months.
pSivida is now permitted to move directly to two phase III trials to treat patients with posterior uveitis. These trials, which pSivida expects would enroll a total of 300 patients, would be in addition to the investigator-sponsored trial announced in June.
“We are very pleased to be cleared to commence phase III clinical trials for the treatment of this blinding disease without the necessity of phase I or phase II trials,” said Paul Ashton, PhD, president and chief executive officer of pSivida Corp.
According to Dr. Ashton, the FDA has agreed that the primary endpoint in these trials will be recurrence of uveitis within 12 months, and also has agreed that the company can reference much of the data, including the clinical safety data, from the clinical trials for an intravitreal implant of fluocinolone acetonide (Iluvien, Alimera Sciences) for diabetic macular edema (DME). Alimera Sciences is a collaborative partner of pSivida.
“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,” Dr. Ashton said. “Because the micro-insert delivers the same drug as our approved product for posterior uveitis (Retisert), we expect to these trials will show efficacy. Further, as the same micro-insert was used in the [intravitreal implant of fluocinolone acetonide for DME] trials, we expect to observe a comparable side-effect profile in [patients with] uveitis as was seen in [patients with] DME. As a result, we are optimistic that our micro-insert will be efficacious for posterior uveitis with a favorable risk/benefit profile."
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