Biotech Values

[DewDiligence]

…why is OPHT excluding occult patients from their trials?

For phase-2b, you know the answer as well as I do because you read it in the 10-K report:

http://www.sec.gov/Archives/edgar/data/1410939/000104746915001507/a2223280z10-k.htm (page 24)

We made no meaningful changes to the inclusion and exclusion criteria in our Phase 2b clinical trial from those we used in our Phase 1 clinical trial. As in our Phase 1 clinical trial, we did not enroll patients with pure occult choroidal neovascularization because it would be difficult to adequately observe and measure the changes in the choroidal neovascular morphology using the imaging techniques that were generally available at most enrolling sites at the time we initiated our Phase 2b clinical trial [emphasis added]. We believed that data regarding neovascular regression would be useful in assessing the effects of Fovista administered in combination with Lucentis and in supporting the anti-neovascularization element of our proposed mechanism of action for Fovista.

This exclusion does not apply to Fovista’s three phase-3 trials:

https://www.clinicaltrials.gov/ct2/show/NCT01944839
https://www.clinicaltrials.gov/ct2/show/NCT01940900
https://www.clinicaltrials.gov/ct2/show/NCT01940887

All told, this issue isn’t meaningful, except perhaps as propaganda for OHRP.