Biotech Values

[WorstLuck]

OCUL

One question that did not come up and is something that makes me wonder is about the re-dose schedule for Sol-R.

Comparing EYPT and OCUL trials as proposed:

EYPT @ 6 months - drug gone, some % of patients need rescue prior to re-dose, carrier vehicle still present to some degree.

OCUL @ 6 months - drug and carrier present, prior rescue unlikely, carrier vehicle still present to some degree.

I haven't found it in slide decks (thus far) but going from memory OCUL is designed to release a final amount of drug at the end of life of the carrier around 8-9 months. By comparison EYPT drug is clearly gone by 6 months and I don't recall the expected eluting pattern, however they had >10% 'supplement' (rescue) at 5 months and > 20% at 6 months. https://investors.eyepointpharma.com/static-files/2f2e6f27-26f6-400f-9e52-a3fec5885ea7 with roughly 2/3 rescue free at month 8.

Both have some kind of "stacking" issue with the carrier at 6 months that probably isn't relevant for the majority of patients.

I do wonder what the effect of having extra drug in the eye for 2-3 months is versus not having enough drug to sustain stable vision for what is probably a high percentage of patients on the other hand. (Current SOC patients also have the problem of the drug being gone, by definition. That is one compelling point of sustained release.) Also, EyleaHD should make my concerns irrelevant?

In practice with approved drugs the dosing schedule would be adjusted to the patient need as insurance allows, which is mostly guided by label.

Given the OCUL team has a lot more experience and success designing registrational trials for AMD than I have criticizing such trials, I wouldn't make too much of this commentary and, if successful, the OCUL re-dose trial should be fantastic commercially.