pSivida microdrug patent paves way for Medidur

pSivida (ASX:PVA) has been granted a US patent for a new inserter for the administration of microdrug delivery devices such as its Medidur implant.

The new patent is based on the company's Durasert injectable implant system, which is a bioerodible implantable delivery device system that fit inside the barrel of a 25 gauge needle.

The company said the new design will allow it to insert drug delivery devices using a far smaller needle, and employing significantly less force than previously required.

pSivida revealed plans to use the new inserter in phase III trials of Medidur, which is a sustained-release drug delivery system for the treatment for posterior uveitis, or inflammation in the back of the eye.

Medidur has also been licensed to US partner Alimera Sciences in 2005 as a treatment for diabetic macular edema, releasing fluocinolone acetonide, but pSivida retains the right to use the technology in other eye diseases including posterior uveitis.

However, Alimera has been struggling to gain FDA approval for Medidur, which Alimera plans to market under the name Iluvien.

In November last year, the US FDA decided not to grant Alimera's application for approval of Iluvien, after declaring that the New Drug Application provided insufficient data showing the safety and efficacy of the implant. The FDA ordered Alimera to conduct two more clinical trials.

This was the second time the FDA knocked back an NDA for the product – in December 2010, the agency declared that an NDA could not be approved in its current form due to the need for more details about product safety, as well as the manufacturing and sterilization process.

Alimera resubmitted an NDA in May 2011. The product has been granted marketing approval in Austria, the UK and Portugal.

If the FDA does eventually approve Alimera's NDA, it could help pSivida more easily gain approval from the agency for the use of Medidur to treat posterior uveitis.

The FDA has already approved two pSivida sustained release products to treat chronic back of the eye diseases: Retisert and Vitrasert. Both products are licensed to Bausch & Lomb Incorporated.

pSivida (ASX:PVA) shares were trading 2.63% lower at $1.850 at around 2:30pm on Thursday.