EyePoint, Inc.: Will LUGANO Prevail in Wet AMD? Assessing Scenarios & Stock Outcomes

研报英文原文证据摘录

EyePoint, Inc.: Will LUGANO Prevail in Wet AMD? Assessing Scenarios & Stock Outcomes

e (see presentation here), were noted to be as expected for this study

design and are relatively similar to phase 3 trials in wet AMD.

• Importantly, the LUGANO and LUCIA trials enrolled a predominantly treatment-naïve

patient population (~76% vs. ~24% previously treated), which should reduce the need for

supplemental injections. The company decided to include treatment-naïve patients in the

trials based on results from DAVIO 2 wherein pseudo-naive patients (those who were

diagnosed with wet AMD ≤1yr with ≤2yr prior anti-VEGF injections) had fewer

supplements than the overall cohort.

• LUGANO and LUCIA do not permit physicians to deliver supplemental anti-VEGF

injections at their own clinical discretion and do not allow for non-protocol rescues (20%

of the rescues that occurred in DAVIO 2 did not meet the rescue criteria). Supplemental

injections are only permitted if a patient meets the predefined criteria — >5-letter loss

from best-on study and ≥75μm of new fluid on OCT from best-on study due to wet AMD

or a site-threatening hemorrhage due to wet AMD— and are adjudicated in a masked

manner to minimize variability and bias. We see these aspects of the trial as helping to

prevent excessive/potentially unnecessary supplemental injections. Together with the

fact that both trials are redosing patients with Duravyu every 6mo (which should benefit

patients who may be losing some efficacy at the end of the dosing interval), we believe

these elements should bode well for the conduct of the trial and the Duravyu arm when

considering the percentage of patients receiving supplemental injections and the number

of supplemental injections.