KeratoScoop (Rebecca's blog)
Drug update: Rebampide
by, 30-Jun-2011 at 00:45 (2023 Views)
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 Co., Ltd. today announced results of a phase III clinical study of its in-development dry eye treatment "rebamipide ophthalmic suspension" for dry eye patients, at ARVO* 2011 (May 1-5, 2011, Fort Lauderdale, Florida, USA).
* ARVO: Association for Research in Vision and Ophthalmology
The phase III study was conducted in Japan on 188 patients with signs and symptoms of dry eye, to examine the efficacy and safety of 2% rebamipide ophthalmic suspension in comparison with 0.1% sodium hyaluronate ophthalmic solution. As the results of the study, it was confirmed that in addition to the improvement in corneal-conjunctival damage in patients with dry eye, rebamipide ophthalmic suspension also showed improvements in subjective symptoms such as foreign body sensation and eye pain and in subject's overall treatment impressions.
Based upon the results of this study, in October 2010 Otsuka Pharmaceutical applied for regulatory approval to manufacture and market rebamipide ophthalmic suspension in Japan. In the U.S., a phase II program with co-development partner Acucela Inc. is ongoing.
Based on its corporate philosophy of "Otsuka-people creating new products for better health worldwide," Otsuka Pharmaceutical Co., Ltd. is dedicated to contributing to the health of people around the world.