**********Ocular Therapeutix SOL-1 Phase 3 Week 52 Data for AXPAXLI in Wet AMD** [developing]** [developing]** [developing]** [developing]** [developing]
Key Questions
What are the key Week 52 post-hoc findings from the SOL-1 Phase 3 trial for AXPAXLI in wet AMD?
The analyses showed median 39/46 weeks to CSFT ≥30/75µm rise with AXPAXLI versus 16/24 weeks with aflibercept, indicating a 30-50% lower risk of worsening. Visual acuity gains were notable, especially +11.8 letters in low-vision patients, and 81% of patients were rescue-free at Week 24.
How does AXPAXLI compare to aflibercept in delaying CSFT worsening?
SOL-1 data demonstrate AXPAXLI delays central subfield thickness (CSFT) worsening, with median times of 39/46 weeks to ≥30/75µm rise versus 16/24 weeks for aflibercept. This reflects a 30-50% lower risk and supports extended disease control.
Does the SOL-1 Week 52 data support an NDA submission for AXPAXLI?
Yes, the positive post-hoc analyses, including delayed fluid rebound, reduced rescue needs, and sustained visual acuity benefits, support a single-trial NDA for AXPAXLI as a durable wet AMD therapy.
Positive Wk52 post-hocs show median 39/46wks to CSFT ≥30/75µm rise vs aflib 16/24wks, 30-50% lower risk, VA gains esp +11.8 letters in low-vision, 81% rescue-free Wk24; supports single-trial NDA for durable wet AMD therapy.