pSivida gets FDA nod for phase III Medidur trial

pSivida (ASX:PVA) has received FDA approval to jump directly to phase III trials of of its Medidur injectable micro-insert to deliver a treatment for the eye disease posterior uveitis.

The US FDA has cleared the company to commence phase III trials without the need for phase I or phase II studies.

The agency has also declared that its Investigational New Drug (IND) application for a posterior uveitis treatment can reference much of the data from the clinical trials conducted by pSivida's partner for the insert, Alimera Sciences.

Alimera has licensed the implant to deliver a treatment for diabetic macular edema, a product which it plans to market as Iluvien, and has been conducting trials to pursue FDA approval. http://www.lifescientist.com.au/article/426951/psivida_microdrug_patent_paves_way_medidur/

pSivida's FDA application meanwhile involves using Medidur to deliver the same drug as its Retisert product – which is already approved by the agency as a posterior uveitis treatment. pSivida CEO Dr Paul Ashton said the company is confident of being able to provide convincing evidence to back up its IND application.

“Because the micro-insert delivers the same drug as our approved Retisert product for posterior uveitis, we expect these trials will show efficacy,” he said.

“Further, as the same micro-insert was used for the Iluvien trials, we expect to observe a comparable side-effect profile in uveitis patients as was seen in DME patients.”

Alimera was last week granted marketing approval for Iluvien in France, http://www.lifescientist.com.au/article/431238/iluvien_march_europe/ and also revealed it is raising US$40 million to fund the launch of the product in Europe. Iluvien has also been cleared in Austria, Portugal and the UK.

pSivida (ASX:PVA) shares had climbed 9.5 per cent to $2.30 by around 3:30pm on Monday.