There is zero chance of this being approved on the basis of a 1 or 2 letter gain. There is some risk involved with these injections which would explain why most clinicians (according to the research the company has cited) would not administer the drug without an average 4 or 5 letter improvement. I would regard anything less than a 3 letter increase as a failure. Something might be salvaged out of sub-group analysis (ie. PCV) but there would need to be another Phase 3 trial if that was to be relied on for approval.
I do believe a 4 or more letter improvement in the Phase 3 trials is likely. The primary endpoint is directed to a sub-group of the Phase 2B (Occult & Minimally Classic -RAP absent) that managed a 5.7 letter improvement, p-value of 0.0002). That's a very strong result. For total patient population (RAP absent) the result was also strong at 4.4 p-value 0.0025.
The big questions are whether the effect will be:
(a) the same in the larger sample size in the Phase 3;
(b) maintained over the 52 weeks of treatment; and
(c) the same in COAST where Aflibercept (Eyelea) was used.
I'm not too concerned about (a) & (c). For me the 52 weeks issue is the main unknown.
IMO/DYOR.
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