Eyepoint misses endpoint on a technicality, needs LUCIA trial results to confirm results
The LUGANO trial results appears to be a miss on a technicality due to the expected 3–5% of patients having unrelated ≥15-letter loss not being replicated in the control arm, difficult to interpret these results now without the follow up LUCIA trial results
9 out of 211 patients experienced ≥15-letter loss not related to wet AMD or the DURAVYU treatment which is within the expected historical pattern seen in comparable aflibercept trials however the aflibercept control arm experienced a highly unusual zero patients experiencing ≥15-letter loss which mean the trial missed its endpoint on what looks like a technicality, awaiting the EyePoint management discussion of the results in the conference call in the next 30 mins, if it is just an anomaly the LUCIA trial results will confirm that so it shouldn't be a total wipeout for the stock until those results are available
Update following the conference call the 9 patients who lost vision were not caused by wet AMD 6 were geographic atrophy (dry AMD), 2 were caused by glaucoma & the last by a detached retina & Cataract
In the original Phase 3 VIEW 1 and VIEW 2 trials of aflibercept (Eylea) in wet AMD, the proportion of patients who lost ≥15 letters by Week 52 was approximately 5% so highly unusual that the control arm had zero patients