Biotech Values

[WorstLuck]

EYPT: Information clean-up.

So why promote drug release prior to bioerosion? How long does the bioerosion actually take? I'm probably not looking in the right place and haven't gotten a response from EYPT IR at this point in time

Got a response back from IR:

The insert elutes drug for approximately 9 months in animals and we would expect a similar range in humans. This is seen in clinical data so far. The inserts in Phase 3 will be over 90% drug. The matrix that holds the drug is fully bioerodible and designed to elute the drug first then bioerode over several months as seen in animals. We don’t know the answer in humans yet, but expect a range depending on the individual.

The good, the bad, and the ugly:

After running all those people through P2 and having had a chance to look at some people in P1, they still don't know how long the drug is eluted. I assume this problem is caused by the insert lasting longer than the elution, so unless we start sacrificing patients (or their eyes) I guess we'll never know. That the elution is expected to take around 9 months clarifies several things for me:
1. That's why some patients will get up to 9 months off a treatment, as seen in P2.
2. Having 20% not make it to 6 months in both 2 and 3 mg arms is weak, IMO. How much is selection criteria and how much is the TKI is an open Q. I suppose it's also possible the elution varies enough between patients to partially account for this. Also see point 6.
3. They've apparently maxed out the drug they can fit into two inserts at 2.7mg. Phase 1 testing only went to 3mg and included a dose under 0.5mg in the range tested. I don't know the rationale.
4. They should have a good idea on how long the bioerosion takes from followup with the trial participants. This is easy to do. The word several suggests two, so I'll take it as three for now - not as bad as it could be with the first insert gone around the time of the second 6-month redose. That would reduce potential stacking issues.
5. Given the elution is timed similarly to that of OCUL opens up some potential comparisons -but- the comparisons still aren't clean and the OCUL dataset is smaller.
6. EYPT trial design, as previously noted, has the first insert done at the same visit as the third loading dose. This should make it much easier to get to 6 months.

I'm done talking about EYPT for the foreseeable future.