Inspire Pharmaceuticals, a biopharmaceutical company, has submitted a clinical protocol and request for special protocol assessment to the FDA for a pivotal Phase III environmental trial with Prolacria for the treatment of dry eye disease.
The protocol is based on information from a detailed analysis of the overall Prolacria clinical trial data to date, including Inspire's Phase III trials and recently completed pilot trial, and consultation with the FDA, Allergan, Inspire's corporate partner, and other dry eye experts.
After detailed analysis, Inspire determined that designing and conducting a further environmental trial was a more appropriate course than further studies of Prolacria in a controlled adverse environment.
Wednesday, November 5, 2008
Inspire update on Prolacria (diquafosol)
Inspire initiates special protocol assessment process for dry eye trial
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2 comments:
To the kind reader whose rant I had to delete in the interests of keeping my blog strictly G-rated, I just want you to know you have not been ignored. I feel your pain - it's frustrating to have this perpetually on the horizon.
Why was it so easy for restasis to get approved and nothing else?
Its ok for those who benefit from restasis.. but what about the rest of us??!!!
All these new allergy eye drops.
If they got to phase 3 and beyond then there must be something in the product that works! send it to market!!
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