KeratoScoop (Rebecca's blog)

A Randomized, Multicenter Phase 3 Study Comparing 2% Rebamipide (OPC-12759) with 0.1% Sodium Hyaluronate in the Treatment of Dry Eye.

OBJECTIVE:
To investigate the efficacy of 2% rebamipide ophthalmic suspension compared with 0.1% sodium hyaluronate ophthalmic solution for the treatment of patients with dry eye.
DESIGN:
Randomized, multicenter, active-controlled parallel-group study.
PARTICIPANTS:
One hundred eighty-eight patients with dry eye.
METHODS:

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Rebamipide (OPC-12759) in the Treatment of Dry Eye: A Randomized, Double-Masked, Multicenter, Placebo-Controlled Phase II Study.

OBJECTIVE:
To investigate the dose response for efficacy of 1% and 2% rebamipide ophthalmic suspension compared with placebo in patients with dry eye.
DESIGN:
A randomized, double-masked, multicenter, placebo-controlled, parallel-group, dose-response phase II study.
PARTICIPANTS:
A total of 308 patients with dry eye.

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Pardon me for not getting excited yet (we've been here before with this drug... long time ago now) but Rebamipide is back in Phase III clinicals. At this point though - rather like Diquafosol - it's already approved on being marketed in Japan. It will be interesting to see whether it makes it through the FDA this time around.

Acucela and Otsuka Pharmaceutical Announce the Initiation of a Phase 3 Clinical Trial to Evaluate Rebamipide Ophthalmic Suspension in Patients with Dry Eye Syndrome ...

This is not new news, but I think I missed it along the way. Otsuka has applied for regulatory approval in Japan for Rebamipide following positive Phase III data, but is supposedly somewhere in Phase II in the US. Have not heard any positive noises about US prospects on this drug for a long time.

May 6 press release

Phase III Study Results for Rebamipide Ophthalmic Suspension for Dry Eye Announced at ARVO 2011

Tokyo, Japan, May 6, 2011 -- Otsuka Pharmaceutical

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