Promising early results from pSivida uveitis trial

pSivida (ASX:PVA) has announced positive data from the first 12 months of a phase I/II study involving using its injectable ocular micro-insert to deliver a treatment for posterior uveitis.

The interim results show that none of the patients receiving the treatment experienced a recurrence of uveitis in their treated eyes over the first 12 months, and inflammation had been reduced.

By contrast, all of the untreated eyes showed either recurrence of uveitis or worsening or unimproved inflammation.

In the most recent follow-up visit, visual acuity had improved by an average of more than nine letters in treated eyes, as measured on the Early Treatment Diabetic Retinopathy Study eye chart. In fellow untreated eyes, acuity had declined by an average of one letter.

The data also show that the micro-inserts were generally well tolerated. One patient did need to have surgery to control intraocular pressure (IOP), but this patient had a history of elevated IOP before treatment. The remaining patients have shown IOPs within the normal range.

pSivida plans to involve up to 12 patients in the three-year, investigator-sponsored trial. The company this month also commenced recruitment for one of two planned US phase III trials that will involve up to 300 patients. These trials will form part of pSivida’s New Drug Application with the US FDA.

The micro-insert used for the treatment is the same design that pSivida has licensed to Alimera Sciences for diabetic macular edema (DME) treatment Iluvien, which is awaiting US approval. pSivida has received permission to cite safety data from Alimera’s trials in its FDA application.

The drug pSivida’s treatment delivers is meanwhile used in the company’s FDA-approved posterior uveitis treatment Retisert.

pSivida CEO Dr Paul Ashton said the company is confident the new treatment will show the same efficacy as Retisert, but with a similar side-effect profile to Iluvien.

“Data from ... the Iluvien DME Phase III studies showed an incidence of serious elevated IOP that was three times lower than that shown in the Retisert Phase III trials, and an incidence of required surgery to treat increased IOP that was lower by a factor of seven,” he said.

pSivida shares were trading 2.44% higher at $4.00 as of around 12.30 pm on Friday.