Wanderdog, could last year’s
update in the Aug 2023 equity raising presentation be what your are looking for, as whytee is suggesting?
Masked data from patients that have completed the week 52 visit in the ongoing Phase 3 clinical trials show greater mean BCVAincreases from baseline than results with standard of care anti-VEGF-A monotherapy from Opthea's Phase 2b study.
Masked data represent pooled data from both OPT-302 combination and standard of care monotherapy treatment arms. The Phase 3 clinical trial masked data are incomplete and subject to additional analysis once unmasked, and our Phase 3 clinical trials are not fully enrolled and the majority of patients enrolled in the trial have not completed the week 52 visit. There is no assurance that standard of care monotherapy in our Phase 3 clinical trials will yield similar results to our prior clinical trials or previously published clinical trials with anti-VEGF-A monotherapies. As a result, there can be no assurance that topline results for OPT-302 from the Phase 3 clinical trial, if completed, will be consistent with results from masked data available to date.
Enrollment back than was 75%, with the majority not having completed w52.
Personally, I’d guess the number of patients having completed w52 by Aug 2023 can be put somewhere between 300 and 500 patients, but this estimate doesn‘t really matter anyway.
Instead, what we know for sure:
P2b monotherapy showed
+10.8 letters
So
all P3 patients taken together (
sham and 2.0 mg q4w and 2.0 mg q8w) that had completed w52 in Aug 2023 showed a BCVA increase from baseline „greater than +10.8 letters“, actually meaning
+10.9 letters or better.
Just for the record some
further details on P2b, as is dates back almost 5(!) years now…:
All lesions (= all patients): sham +10.8 letters vs 2.0 mg +14.2 letters (delta +3.4 letters, p=0.0107)
All lesions ex RAP (= those to be enrolled into P3): sham +10.6 letters vs 2.0 mg +15.0 letters (delta +4.4 letters, p=0.0025)
Minimally classic and occult lesions ex RAP (= those to be looked at for P3 topline data): sham +10.3 letters vs 2.0 mg +16.1 letters (delta +5.7 letters, p=0.0002)
(20min delay)