Replies to post #252301 on Biotech Values

[iwfal]

I assume the purpose of C is to mask the Axpaxli arm; patients and investigators won’t know whether the injection every 6 months is Eyelea or Axpaxli. But I don’t think they said that explicitly unless there was something in the Q&A that I missed.

FWIW I do not know whether they used the specific term “masking arm”, but regardless that’s clearly what it is. Trials designed to avoid shams and preserve blinding end up looking different.

[WorstLuck]

You refer to arm C as the “masking arm” but Ocular in the presentation (slides 54 and 61) calls it the “comparator arm”. I think you are right, the trial is comparing Axpaxli every 6 months to Eyelea every 8 weeks, so I don’t see why they call C the comparator.

It's just language conforming to the FDA guidelines.

B. Comparator

Sponsors developing drugs for the treatment of neovascular age-related macular degeneration
should consider the following regarding comparative clinical trials:

• Each investigational drug arm is expected to have at least one other comparative arm in
which the dosing frequency, criterion for dosing adjustments, and criterion for
interventions are the same.

At appx 43:00 in the presentation he mentions that the third arm is for masking purposes only.

I assume the purpose of C is to mask the Axpaxli arm; patients and investigators won’t know whether the injection every 6 months is Eyelea or Axpaxli. But I don’t think they said that explicitly unless there was something in the Q&A that I missed.

The big deal isn't the language. The big deal is understanding the trial design and that it would be run at regulatory risk, final design pending type C meeting feedback so the regulatory risk can't be quantified yet. Listen starting at about 50:00 panelist comment re regulator risk.