Thanks, PigRace! I’ve added information from EyeBio’s website and your comments into the Opthea GPT and created this Q&A about a Restoret as a competitor.
PigRace (or anyone) if you has suggestions for improvements or notices any inaccuracies, please feel free to point them out and I will update.Competitor Q&A: EyeBio’s Restoret
.Q E1: What is Restoret, and what were the key results from its AMARONE trial?
A: Restoret is an investigational drug developed by EyeBio for treating retinal diseases, including DME and wAMD. In the AMARONE trial, Restoret showed a +11.2 letter gain in visual acuity in treatment-naive DME patients when used as monotherapy. For the wAMD group, which included only 5 patients, the total visual acuity gain was around 11 letters, including the effects of aflibercept, making it difficult to isolate Restoret's specific contribution.
.Q E2: How does the AMARONE trial compare to Opthea's OPT-302 Phase 2b trial?
A: The OPT-302 Phase 2b trial enrolled 366 treatment-naive wAMD patients, providing more robust and statistically significant data. In contrast, the AMARONE trial had a much smaller sample size with only 31 total patients and limited data for wAMD, making the results less conclusive.
.Q E3: What is the current status and future timeline for Restoret's development?
A: Restoret is in the early stages of clinical development. Following the AMARONE trial, EyeBio plans to initiate a Phase 2b/3 trial for wAMD in Q4 2024, with topline data expected by Q2 2026. A subsequent Phase 3 trial is projected to begin in Q4 2026, with potential market entry not expected until after 2029. This timeline places Restoret approximately 4 years behind Opthea’s Sozinibercept.
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