“UBS Downgrades Shire Due to Risk from Clinical Trials.” We don’t normally present investment community news on this blog however this headline is another example showing the current system used to obtain FDA approval for dry eye disease (DED) products is flawed. For over a decade we have observed the irony and disappointment of no FDA Rx approvals for the most common condition eye doctors see every day! Shire pharmaceutical is just the latest in a long trail of companies that have together have spent hundreds of millions of dollars in the quest for an approval. Isn’t it time to look at other markers that are truly objective and less variable such as tear osmolarity and MMP-9 tests, to name a couple? Several months ago Dr Paul Karpecki opined on this subject in an article titled “Why Dry Eye Trials Often Fail” published in the Review of Optometry and yet again it continues.
The old system of corneal staining, subjective symptoms and the like have failed miserably mainly because the enrollment criteria as well as primary endpoints are flawed. Analyst Guillaume van Renterghem noted that 14 projects for dry eye have been unsuccessful over the past 10 years and believes the failure is due to identifying appropriate patients. UBS wrote that it is difficult to identify “patients with pure dry eye and excluding patients with dry eye like symptoms.”
Remember the definition of insanity is “repeating the same mistake over and over and expecting to get the different result“. Erika Janowicz, a Benzinga Staff Writer discusses here.
Read Dr. Karpecki’s article here.