Abstract
Purpose :
AIV007 is a potent, broad-spectrum multi-kinase inhibitor with dual action against angiogenesis and fibrosis. It possesses a novel mechanism of action that may be critical in improving treatment effectiveness in AMD and DME. Its novel JEL™ technology formulation is engineered for prolonged drug release. The ongoing phase 1 trial aims to assess the safety, duration of effect, and pharmacokinetics of AIV007 through a single periocular injection in patients with nAMD or DME.
Methods :
AIV007-E02 (NCT05698329) is an ongoing, multicenter, open-label, dose-escalation study enrolling eligible nAMD or DME patients with a history of response to anti-VEGF treatment. The primary endpoint is the rate of adverse events (AE) and serious adverse events (SAE). The secondary endpoints include mean change from baseline in best-corrected visual acuity (BCVA) and in central subfield thickness as measured by spectral domain optical coherence tomography (SD-OCT). Safety and efficacy assessments are performed at 28-day intervals throughout 168 days after a single AIV007 administration.
Results :
During the abstract submission, the trial remains in progress. Six subjects (5 DME & 1 nAMD) with a history of persistent retinal fluid following anti-VEGF treatment are currently enrolled. Four subjects completed the study and exited at 6 months post-treatment. Preliminary findings indicated a favorable safety profile, with mild or moderate ocular AEs and no reported drug-related SAE or systemic AEs. Notable improvements in BCVA were evident, with up to a 16-letter gain by 84 days (about 3 months) and up to 4 letters gained over 168 days (about 6 months) post AIV007 administration. At 168-day exit (n=4), the improved or stable central subfield thickness (CST) was noted.
Conclusions :
AIV007 holds the potential as a safe and effective treatment for patients with nAMD and DME through a less invasive and durable treatment approach. Our approach in clinical development is to leverage the AIV007’s novel mechanism of action, simple route of administration, and sustained release formulation to improve visual outcomes and eliminate the need for frequent intravitreal injections.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.