0:37 Background of Dr. Baldwin
9:56 Promising data on OPT-302/sozinibercept
16:39 Making decisions as a clinician, industry leader
22:11 Future of the treatment landscape
28:24 What’s next for Opthea?
The latest episode of New Insight with Veeral Sheth, MD, features a conversation with Megan Baldwin, PhD, the CEO and managing director of Opthea Limited, on OPT-302 (sozinibercept), a treatment for wet age-related macular degeneration (AMD) and other retinal diseases.
Sozinibercept, is a novel “trap” fusion protein that inhibits vascular endothelial growth factors C and D (VEGF-C, VEGF-D), ligand mediators of angiogenesis and vascular leakage involved in retinal vascular diseases.
The molecule is being evaluated in two phase 3 clinical trials for wet AMD and is administered via intravitreal injection in combination with standard-of-care anti-VEGF-A therapy. These trials include the ShORe trial of 2 mg sozinibercept + 0.5 mg ranibizumab, and the COAST trial of 2 mg sozinibercept + 2 mg aflibercept.
It has received fast-track designation from the US Food and Drug Administration. At the American Society for Retina Specialists 41st Annual Meeting, new data suggested sozinibercept combination therapy had a favorable safety and tolerability profile, compared to standard-of-care anti-VEGF-A monotherapy.
In this episode of New Insight with Veeral Sheth, MD, experts discuss the exciting promise of sozinibercept, how it may fit into the ophthalmologist’s armamentarium, and the behind-the-scenes work that goes into creating a new molecule.
Dr. Baldwin shares insight into her background, her PhD research work on VEGF-D, and her movement toward the drug development space. She described joining Opthea, her growth at the company, and ultimately, her move to CEO as the company made a pivotal move from oncology to ophthalmology.
Baldwin described the opportunity the novel pathway presented, the effort to raise capital and gain support from shareholders and the larger market and working to improve the standard of care to maximize patient outcomes with this new mechanism.
The experts touched on the data from the clinical trial program, the importance of not only durability in treatment, but improved visual acuity, and working to shut down the disease progression as early as possible. They discussed the difference in decision-making between being a clinician and an industry executive, as challenges may arise between these two viewpoints.
Baldwin described the shift into the ophthalmology market as requiring highly strategic focus and proper assessment, ultimately deeming it completely the right decision for the company. She noted that positive data helps justify these decisions, but day-to-day challenges still arise and require making compromises and defending those decisions to stay on that critical path.
Experts discussed the future of the field, as treatment options continue to be added, and how sozinibercept may slot into that armamentarium. They discussed the potential for individualizing treatment, as more therapies become available, and how this might change the approach to patient management in ophthalmology. To conclude, the expert touched on the future of sozinibercept and where the company may be headed in the near future.
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