Drug InformationQ D1: What is Sozinibercept (OPT-302)?A:...

Drug Information

Q D1: What is Sozinibercept (OPT-302)?
A: Sozinibercept (OPT-302) is a novel biologic drug developed by Opthea, designed to inhibit VEGF-C and VEGF-D, in addition to being used in combination with standard anti-VEGF-A therapies for the treatment of wet Age-related Macular Degeneration (AMD). By targeting VEGF-C and VEGF-D, Sozinibercept aims to reduce vascular leakage and abnormal blood vessel growth more comprehensively than existing treatments that target VEGF-A alone. This broader spectrum of inhibition could potentially address the needs of patients who do not fully respond to anti-VEGF-A therapies. Sozinibercept is currently undergoing evaluation in pivotal Phase 3 trials (COAST and SHORE) for wet AMD.

Q D2: What is Eylea, and how does it work?
A: Eylea (aflibercept) is a widely-used anti-VEGF therapy that functions as a VEGF trap, binding to VEGF-A, VEGF-B, and PlGF (placental growth factor). By inhibiting these factors, Eylea reduces abnormal blood vessel growth and fluid leakage in the retina, which are hallmarks of wet AMD. Eylea is administered through intravitreal injections, typically on a monthly or bi-monthly basis, depending on the patient's response. It has been a cornerstone treatment for wet AMD, with global annual sales exceeding several billion dollars, reflecting its efficacy and widespread adoption.

Q D3: What is Lucentis, and how does it work?
A: Lucentis (ranibizumab) is another leading anti-VEGF therapy specifically designed to bind and inhibit VEGF-A. Like Eylea, Lucentis is used to treat wet AMD by preventing VEGF-A from promoting the growth of abnormal blood vessels and causing fluid leakage in the retina. Lucentis is also administered through intravitreal injections, typically on a monthly schedule. It has been highly effective in improving visual outcomes for patients with wet AMD and plays a significant role in the global market for anti-VEGF therapies.

Q D4: What are the differences between Sozinibercept and current treatments like Eylea and Lucentis?
A: While Eylea and Lucentis primarily target VEGF-A (with Eylea also targeting VEGF-B and PlGF), Sozinibercept (OPT-302) is designed to inhibit VEGF-C and VEGF-D, in addition to VEGF-A. This broader inhibition aims to provide additional benefits in reducing abnormal blood vessel growth and leakage, particularly in patient sub-groups that are less responsive to VEGF-A inhibition alone. By being used in combination with existing treatments like Eylea or Lucentis, Sozinibercept has the potential to improve visual outcomes for a wider range of patients with wet AMD.

Q D5: How does Sozinibercept (OPT-302) interact with standard anti-VEGF therapies?
A: Sozinibercept (OPT-302) is intended to be used in combination with standard anti-VEGF therapies, such as Eylea (aflibercept) or Lucentis (ranibizumab). By simultaneously targeting VEGF-A, VEGF-C, and VEGF-D, the combination therapy aims to more comprehensively inhibit the angiogenic pathways involved in wet AMD. This dual approach could potentially enhance treatment efficacy, particularly in patients who have not achieved optimal results with anti-VEGF-A therapy alone.

Q D6: What are the potential advantages of Sozinibercept over other emerging treatments for wet AMD?
A: The primary advantage of Sozinibercept (OPT-302) is its ability to target multiple VEGF family members (VEGF-C and VEGF-D) in addition to VEGF-A. This could provide a more comprehensive inhibition of the angiogenic pathways driving wet AMD. Additionally, its combination with existing therapies may offer enhanced efficacy without significantly increasing the treatment burden. Sozinibercept's unique mechanism of action could make it particularly beneficial for patients who have shown limited responses to current anti-VEGF-A treatments. However, the ultimate clinical advantage will be determined by the outcomes of the ongoing Phase 3 trials.

Q D7: What is the safety profile of Sozinibercept (OPT-302) compared to existing treatments?
A: Based on the results from the Phase 2b trials, Sozinibercept (OPT-302) has demonstrated a safety profile comparable to existing anti-VEGF therapies. The most commonly reported side effects were mild and included eye-related events such as conjunctival hemorrhage, eye pain, and intraocular inflammation, which are typical of intravitreal injections. Ongoing Phase 3 trials (COAST and SHORE) will provide more comprehensive safety data in a larger patient population, which will be critical for determining its suitability for widespread use.

Q D8: What impact could Sozinibercept have on the market for wet AMD treatments?
A: If Sozinibercept (OPT-302) demonstrates significant efficacy and safety in the ongoing Phase 3 trials, it could become a valuable addition to the market for wet AMD treatments. By offering a new mechanism of action that targets multiple VEGF family members, Sozinibercept could complement existing therapies and potentially improve outcomes for patients who are not fully responsive to current treatments. This could lead to broader adoption of combination therapies, potentially expanding the market and offering a competitive edge for Opthea in the growing anti-VEGF market.