“We are pleased to have FDA agreement on the primary endpoint for Phase 3 pivotal trials of APX3330 which we believe is the most advanced oral therapy currently in development for diabetic retinopathy,” said George Magrath, M.D, MBA., M.S.,...
The purpose was to determine the efficacy of oral administration of APX3330 to reduce lesion size in a laser-induced choroidal neovascularization (L-CNV) mouse model and to develop a physiological-based pharmacokinetic (PBPK) model for retinal delivery of APX3330 to confirm dosing for a Phase ...
“We look forward to working with the FDA to confirm the Phase 3 study design and advancing APX3330 towards a potential NDA submission,” Rodgers concluded in the release. At the meeting, David Lally MD, will present ZETA-1 Phase 2 Trial Efficacy Results for APX3330: a Novel...
Safety and Efficacy of an Oral Therapeutic APX3330 from ZETA-1 Phase 2 Trial in Patients with Diabetic Retinopathy, was delivered by David Lally, M.D. F.A.S.R.S. at the Clinical Trials at the Summit (CTS) 2023 meeting in Park City, Utah on Saturday, June 10. ...
The inclusion criteria and scale used in this post-hoc analysis will be used in future APX3330 Phase 3 studies Results : Results of the primary endpoint were presented at ARVO last year (Su et al, 2023; IOVS 64(8):3753). A post-hoc analysis of 68 subjects with 2 qualified eyes ...
timing and occurrence of an End-of-Phase 2 meeting with the FDA, the potential of a Phase 3 registration path for APX3330, the success and timing of planned regulatory filings, business strategy, cash runway...
ZETA-1 was a multi-center, placebo-controlled, double-masked Phase 2 trial. Subjects were randomized 1:1 to receive APX3330 (total 600 mg/day) or placebo BID for 24 weeks. Eligible subjects had non-proliferative DR (NPDR) or mild proliferative DR, corresponding to DR severity scale (DRSS...
“forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning the End-of-Phase 2 meeting with the FDA to confirm Phase 3 registra...
“forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning the End-of-Phase 2 meeting with the FDA to confirm Phase 3 r...