Risks and Competitors.Q F1: What is Restoret, and what were the...

Risks and Competitors
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Q F1: What is Restoret, and what were the key results from its AMARONE trial?

A: Restoret is an investigational drug developed by EyeBio aimed at treating retinal diseases such as Diabetic Macular Edema (DME) and Wet Age-related Macular Degeneration (wAMD). In the AMARONE trial, Restoret demonstrated a +11.2 letter gain in visual acuity in treatment-naive DME patients when used as monotherapy. However, in the wAMD group, which included only 5 patients, the overall visual acuity gain was around 11 letters, including the effects of aflibercept, making it difficult to ... isolate Restoret's specific contribution to the improvement in visual acuity. The small sample size in the wAMD group limits the conclusiveness of the results, especially when compared to larger trials like those conducted for Opthea's Sozinibercept (OPT-302). As a result, while the initial results are promising, further trials with larger patient populations will be necessary to fully understand Restoret's efficacy and safety profile in treating wAMD.
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Q F2: How does the AMARONE trial compare to Opthea's OPT-302 Phase 2b trial?

A: The OPT-302 Phase 2b trial was significantly larger and more robust, enrolling 366 treatment-naive wAMD patients. This provided statistically significant data, showing a +5.7 letter improvement in visual acuity when OPT-302 was combined with Lucentis. In contrast, the AMARONE trial had a much smaller sample size of only 31 total patients, with limited data on wAMD, making its results less conclusive compared to Opthea’s trial.
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Q F3: What is the current status and future timeline for Restoret's development?

A: Restoret is still in the early stages of clinical development. Following the AMARONE trial, EyeBio plans to begin a Phase 2b/3 trial for wAMD in Q4 2024, with topline data expected by Q2 2026. A subsequent Phase 3 trial is expected to start in Q4 2026, with potential market entry likely not occurring until after 2029. This timeline places Restoret approximately 4 years behind Opthea’s Sozinibercept in terms of development and market entry.
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Q F4: What are the key risks associated with the development of Sozinibercept (OPT-302)?

A: The development of Sozinibercept carries several risks:

• Clinical Trial Risk: The Phase 3 trials may not achieve the expected endpoints, which could delay or prevent regulatory approval.
• Regulatory Risk: Even if the trials are successful, there’s no guarantee that regulatory bodies like the FDA will approve the drug.
• Market Risk: The competitive landscape for Wet AMD treatments is evolving, with new therapies potentially impacting the market share of Sozinibercept.
• Financial Risk: Opthea may require additional funding to complete the trials and bring Sozinibercept to market, leading to potential dilution of existing shares or increased financial pressure.
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Q F5: Who are the other major competitors in the Wet AMD treatment space?

A: Besides EyeBio’s Restoret, other major competitors in the Wet AMD treatment space include:

• Genentech/Roche: Developers of Lucentis (ranibizumab) and Faricimab, which target VEGF and Angiopoietin-2, respectively.
• Regeneron: Makers of Eylea (aflibercept), a leading anti-VEGF therapy.
• Novartis: Involved in the development of Beovu (brolucizumab), which also targets VEGF.

These competitors are well-established in the market, and their ongoing developments could impact the adoption and success of Sozinibercept.
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Q F6: What are the standard disclaimers provided by Opthea, and what do they mean in simple terms?

A: Opthea typically includes several standard disclaimers, such as:

• Forward-Looking Statements: These disclaimers indicate that the company’s projections and statements about future events, like clinical trial outcomes or financial performance, are based on current expectations and involve risks and uncertainties. This means there’s no guarantee these projections will be realized.
• Clinical and Regulatory Risks: Opthea highlights the risks associated with clinical trials and the regulatory approval process. Simply put, even if a drug shows promise in early trials, it might not be approved or might face delays in approval.
• Market Risk: The disclaimers often note that the market for a new drug is uncertain and depends on many factors, including competition, pricing, and adoption by doctors and patients. This means that even if a drug is approved, it may not achieve the expected sales or market share.

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