Palm Beach, FL 7/19/12 (StreetBeat) – Shares of Psivida Corp (Nasdaq: PSDV) surged 37% Thursday following the U.S. health regulators clearance of its experimental eye insert to skip initial studies and proceed directly to late-stage trials. The insert is a sustained-release device injected into the back of the eye and aims to treat posterior uveitis. Posterior Uveitis, classified as the 3rd largest cause of blindness in the US, is an inflammatory disease of one of the layers of the eye.
"As the same micro-insert was used in the Iluvien trials, we expect to observe a comparable side-effect profile in uveitis patients as was seen in diabetic macular edema patients," Chief Executive Paul Ashton said. Iluvien has been rejected twice by the FDA, but is currently approved to treat retinal swelling in diabetic patients in the UK, Austria, France, and Portugal.
Psivida added that “since the experimental insert delivers the same drug as its other insert Retisert, which is FDA-approved to treat posterior uveitis, the company expects to see favorable efficacy in the late-stage studies”.
Shares are currently trading at $2.94, up $.80 or 37%.
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