Ocular Therapeutix begins enrollment for phase 3 SOL-R clinical trial for wet AMD

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Ocular Therapeutix announced the first patients have been enrolled in its Phase 3 SOL-R trial (NCT06495918) evaluating its axitinib intravitreal implant, also known as OTX-TKI (AXPAXLI) for the treatment of patients with wet age-related macular degeneration (wet AMD).

AXPAXLI, an axitinib intravitreal implant, is a bioresorbable, hydrogel implant incorporating axitinib. Axitinib is a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties.

Pravin U. Dugel, MD, executive chairman, president and CEO of Ocular Therapeutix commented on AXPAXLI and the company’s other phase 3 trial, SOL-1, in a press release.¹

“Our first Phase 3 trial, SOL-1, is intended to show that AXPAXLI can safely and durably maintain visual acuity in patients with wet AMD. SOL-R is intended to build on that by providing physicians with important evidence regarding the potential to re-dose AXPAXLI every 6 months, which better aligns with a likely ‘real world’ experience,” said Dugel.

Dugel commented on the trial design by saying, “SOL-R will initially enroll patients who do not qualify to be randomized in SOL-1. Subsequently, SOL-R will be opened to direct enrollment of patients who are treatment naïve or diagnosed with wet AMD within 3 months prior to enrollment. Patients enrolled in SOL-R are similar to those enrolled in our successful U.S. Phase 1 study, with further enrichment through multiple aflibercept loading doses. Further, these patients are evaluated to limit retinal fluid fluctuations between visits prior to randomization, increasing our confidence in the study’s potential success.”

The phase 3 SOL-R clinical trial will evaluate AXPAXLI in a multi-center, double-masked, randomized (2:2:1), 3-arm study. Goals of the study are to randomize approximately 825 patients globally who are treatment naïve or have been diagnosed with wet AMD within 3 months prior to enrollment.

The 1-year, non-inferiority study includes multiple loading doses of aflibercept and monitoring to exclude those with significant retinal fluid fluctuations. Patients in the first arm will be randomized to receive a single dose of AXPAXLI at Day 1 and will be re-dosed at Week 24. Patients in the second arm will receive aflibercept (2 mg) on-label every 8 weeks. While patients in the third arm will receive a single dose of aflibercept (8 mg) at Day 1 and will be re-dosed at Week 24, aligned to the AXPAXLI treatment arm for adequate masking.^1,2

The primary endpoint for the SOL-R clinical trial is non-inferiority in mean best corrected visual acuity (BCVA) change from baseline between the AXPAXLI and on-label aflibercept (2 mg) arms at one year.^1,2

References:

1. Ocular Therapeutix announces first patients enrolled in Phase 3 SOL-R wet AMD study. News Release. July 30, 2024. Accessed July 30, 2024. https://www.globenewswire.com/news-release/2024/07/30/2920887/0/en/Ocular-Therapeutix-Announces-First-Patients-Enrolled-in-Phase-3-SOL-R-Wet-AMD-Study.html

2. Study to evaluate the efficacy and safety of intravitreal OTX-TKI (axitinib implant) in subjects with neovascular age-related macular degeneration. NCT06495918. Accessed July 30, 2024. https://clinicaltrials.gov/study/NCT06495918?id=NCT06495918&aggFilters=status:not%20rec&rank=1&tab=table