The Dry Eye Zone

Rebecca's Blog


Drug news: The latest on Prolacria

Excerpt from Inspire's February 26th investor call below. Bottom line, they're now enrolling patients for a pilot study and have given a little more information on what they'll be studying. For those who don't have a context for this, Prolacria (diquafosol tetrasodium) failed FDA approval 3 times and Inspire opted in 2007 to go back and do more clinical trials. For patience and persistence, we've really got to hand it to them.

In 2007, we made progress in our dry eye program by identifying a reasonable path forward to potentially obtain regulatory approval of Prolacria. As we’ve previously indicated, based on analysis of our existing clinical data and input from dry eye experts as well as several meetings held with the FDA, we are now focusing our efforts on evaluating the effects of Prolacria on the central region of the cornea as measured by fluorescein staining scores.

Today, we want to let you know that we are now actively enrolling patients in a pilot trial studying Prolacria and ORA’s proprietary dry eye model. The purpose of this trial is to confirm an appropriate clinical trial designed to be used for a potential pivotal Phase III clinical trial. If the data from the pilot study is favorable, we plan to move this program forward aggressively. Based on current plans in the program, we are on track to provide you with an update on our progress and potential next steps for the third quarter of 2008.

Today, we are also pleased to provide you with an update regarding the development of this dry eye product in Japan. Our Asian partner, Santen Pharmaceuticals, a premier ophthalmology company in Asia, has made significant progress in their Phase III program over the past year. Santen has now publicly stated that they plan to file an application for marketing approval with regulators in Japan in the July to September timeframe this year. We will be eligible to receive a modest cash milestone payment upon completion of the Phase II testing and we will receive royalties in Japan as well as non-other Asian countries that the product is ultimately approved. In Japan, alone, there is an estimated 8 million dry-eye sufferers, so it is a large market there as well. Santen has extensive experience in this market and we are encouraged by the progress in the development of the product in Japan.