What is it?
A tiny (3.5mm!) injectable, sustained-release drug delivery system containing fluocinolone acetonide that can last for up to three years.
Why am I bringing this up?
Because the company that makes Durasert (pSivida) announced that their second Phase 3 trial met it’s primary endpoint.
The trial showed that Durasert had a significant reduction in the recurrence of posterior uveitis through six months. To give you some numbers, 21% of the Durasert group had a recurrence as compared to 53% of the sham group.
How was the IOP?
During the first 6 months, 41% of the Durasert group required IOP-lowering therapy vs 34% for the sham group.
Why does the company say Durasert is so great?
Because recurrent posterior uveitis is typically treated with systemic steroids which can have serious side effects. Durasert is a one time injection that can last 3 months without the systemic side effects.
The company plans to submit a new drug application to the FDA at the end of the year so Durasert could be FDA approved in 2018. Stay tuned.