AXPAXLI (axitinib intravitreal implant)

Expected outcomes are based on one completed phase 3 trial (SOL-1, Week 52) and two phase 1 trials; no peer-reviewed publication of phase 3 results and no repeat-dosing efficacy data are available. In SOL-1, among treatment-naive participants who responded to aflibercept loading, 74.1% of participants treated with a single 450 µg implant maintained vision (loss of fewer than 15 letters) at Week 36 versus 55.8% with a single aflibercept 2 mg injection, and 65.9% versus 44.2% at Week 52; 68.8% versus 47.7% were rescue-free at Week 52 under the SOL-1 rescue criteria. In a post hoc analysis applying SOL-R rescue criteria, the sponsor estimated a 72% reduction in injection burden (56% including loading doses) versus projected on-label aflibercept 2 mg every 8 weeks over 60 weeks. In the U.S. phase 1 trial of the first-generation 600 µg implant in previously treated participants, 60% were rescue-free through Month 12 and treatment burden was reduced by 89%. Expected adverse effects include vitreous floaters (12.4% versus 1.2% with aflibercept through Week 52), which the sponsor attributes to hydrogel bioresorption, and mild or moderate intraocular inflammation (9 events in 7 participants); no endophthalmitis or retinal vasculitis was reported in the implant arm. Long-term effects on fibrosis, macular atrophy, and vision beyond 2 years are unknown and are being evaluated in SOL-X (estimated 850 participants, primary completion 2030) and at Week 96 in SOL-R.