Release Date: March 05, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: For your wet AMD pivotal program, how many clinical sites have been activated across the trials of your overall target so far? A: We have most of the sites already activated in the US, especially the strong ones. In terms of ex-US, we are planning to have between 60 and 80 sites per study, which should be coming later this year. Currently, we have approximately 60 active sites per study. - Ramiro Ribeiro, Chief Medical Officer
Q: Can you comment on the analysis presented yesterday in the supplement, particularly the dose response between the 2.7 mg and 1.3 mg doses? A: The subgroup analysis of non-supplemented patients shows how powerful DURAVYU was in this DME population. We see evidence of dose response between the 2.7 mg and 1.3 mg doses. The 2.7 mg dose, which is used in pivotal trials, showed significant improvement. - Jay Duker, President, Chief Executive Officer
Q: Are you able to characterize the type of patients you are recruiting for the wet AMD trials? A: We have capped previously treated patients at approximately 25% in LUGANO, so the majority are treatment-naive. We don't expect to enroll more previously treated patients. - Jay Duker, President, Chief Executive Officer
Q: Have you considered any opportunities to conduct post-marketing studies for DURAVYU long term? A: Yes, we are considering post-approval studies, such as comparing DURAVYU against current industry leaders like high-dose Eylea or VABYSMO. We are also exploring additional benefits like prevention of atrophy in wet AMD patients. - Jay Duker, President, Chief Executive Officer and Ramiro Ribeiro, Chief Medical Officer
Q: Can you give more color on your plans to meet with US and ex-US agencies regarding the DME program? A: We plan to meet with both the FDA and EMA to gather regulatory feedback globally. The discussions will focus on the design of the study, aiming for an efficient approach. We expect to provide an update after receiving written minutes from these meetings. - Jay Duker, President, Chief Executive Officer and Ramiro Ribeiro, Chief Medical Officer
Q: Could you talk about the Northbridge manufacturing facility and any potential CMC issues? A: The Northbridge facility is a state-of-the-art 41,000 square foot site focused on clinical execution and commercial readiness. We have involved the FDA early in the design and execution, and we are prepared for registration batches and pre-approval inspections. - George Elston, Chief Financial Officer, Executive Vice President
Q: How would DURAVYU's potential every 6-month label compare to other potential treatments in the market? A: We believe an every 6-month label is preferred by physicians, offering flexibility to tailor treatment to maximize vision and minimize visits. DURAVYU is designed to deliver therapeutic levels consistently for 6 months. - Jay Duker, President, Chief Executive Officer
Q: What are the plans for initiating a Phase 3 trial in DME, and would you consider partnering for this indication? A: We currently have no plans to initiate a pivotal trial in DME in 2025, aiming for 2026. We would welcome a partner, but it would need to be part of a larger structured partnership. - Jay Duker, President, Chief Executive Officer
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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