Product information and disease description Product description Product information Dosing and administration

Dosage

5 evidence topics · 4 sources

SOL-1: single dose after aflibercept loading, with redosing at Weeks 52 and 76

“Subjects who achieve best corrected visual acuity (BCVA) of 20/20 at Day 1 (baseline) or gain at least 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at Day 1 along with a CSFT of ≤350 μm were then randomized to receive a single dose of AXPAXLI (0.45 mg) or a single dose of aflibercept (2 mg). At Week 52 and at Week 76, all subjects are re-dosed with their respective initial treatment of AXPAXLI (0.45 mg) or aflibercept (2 mg).” (opens the source at this quote in a new tab)

SOL-R: dosing every 24 weeks

“Subjects in the first arm of the SOL-R trial received a single dose of AXPAXLI 450 μg at Day 1 and are re-dosed with AXPAXLI 450 μg at Weeks 24, 48, and 72.” (opens the source at this quote in a new tab)

SOL-X: long-term dosing every 24 weeks

“According to the trial design, all subjects will be given AXPAXLI every 24 weeks, starting at Day 1 (after completion of the Week 104 visit in SOL-1, or Week 96 visit in SOL-R), and again at Weeks 24, 48, 72, 96, and 120.” (opens the source at this quote in a new tab)

U.S. phase 1 trial: single 600 µg first-generation implant with one aflibercept injection

“The U.S.-based Phase 1 clinical trial is a prospective, multi-center, randomized, controlled study in subjects previously treated with anti-VEGF therapy that is evaluating a 600 μg dose of OTX-TKI in a single implant, with a 2 mg aflibercept injection four weeks after the implant, compared to 2 mg aflibercept injections administered every 8 weeks.” (opens the source at this quote in a new tab)

Redosing interval informed by bioresorption and disease reactivation

“Four subjects received rescue therapy for the first time at Month 12, indicating the waning of OTX-TKI’s therapeutic effect and potential disease reactivation, which helps establish a re-dosing timeline for patients.” (opens the source at this quote in a new tab)

“Terminal drug release at bioresorption creates a flexible redosing period” (opens the source at this quote in a new tab)

Proposed labeled dose, dosing interval, and dose modification

No evidence found.