pSivida to begin clinical trial

North Perth based biomedical company pSivida has announced that enrolment for a clinical trial of their Medidur product has begun.

The clinical trial will asses safety and effectiveness of the Medidur product, which is a small injectable intravitreal device, designed to release fluocinolone acetonide to the retina for up to three years.

This treatmeant is designed for patients who are suffering Lucentis, the leading cause of vision loss in people over 65 in the developed world.

Full announcement below:

pSivida Limited announced today that enrolment has begun for a clinical trial to assess the safety
and efficacy of Medidur FA in conjunction with Lucentis® (ranibizumab injection,
Genentech) in patients with exudative age-related macular degeneration (wet AMD).
The study is designed to provide preliminary information on the potential of Medidur FA
to maintain the efficacy established with Lucentis while reducing the overall number of
Lucentis treatments.
Performed under an investigator sponsored IND, the study will compare two doses of
Medidur FA (0.2 and 0.5 ug/day) in patients that have been treated with Lucentis for at
least six months. The change from baseline in parameters such as visual acuity and
retinal thickness will be assessed, and the number of Lucentis injections required pre
and post-treatment will be compared.
"The approval of Medidur to treat Wet AMD could dramatically increase the market
potential for Medidur FA. Under our revised agreement with Alimera Sciences, Alimera
is responsible for funding all Medidur FA development costs," said Dr. Paul Ashton,
Managing Director of pSivida.
- Medidur FA is a tiny injectable intravitreal device designed to release
fluocinolone acetonide to the retina for up to three years. It is presently in a fully
enrolled Phase III clinical trial for the treatment of Diabetic Macular Edema (DME).
- Wet AMD is the leading cause of vision loss in people over 65 in the developed
world and is characterized by the formation of leaky new blood vessels originating in
the choroid which may haemorrhage and cause accumulation of sub- and intraretinal
fluid.
- Lucentis is approved for the treatment of wet AMD and requires repeated
injections directly into the eye to maintain efficacy.