Clinical Scorecard: Axpaxli Superior to Aflibercept in Wet AMD Trial
At a Glance
| Category | Detail |
|---|---|
| Condition | Neovascular (wet) age-related macular degeneration (nAMD) |
| Key Mechanisms | Axpaxli is a bioresorbable intravitreal hydrogel delivering axitinib, a tyrosine kinase inhibitor with antiangiogenic activity |
| Target Population | Treatment-naïve patients with wet AMD |
| Care Setting | Ophthalmology clinics with intravitreal injection capability |
Key Highlights
- Axpaxli demonstrated superior visual acuity maintenance compared to aflibercept at weeks 36 and 52 in the phase 3 SOL-1 trial
- Axpaxli showed better anatomic control of central subfield thickness and sustained fluid control on OCT imaging
- Safety profile was favorable with no treatment-related serious ocular adverse events reported
Guideline-Based Recommendations
Diagnosis
- Diagnosis of wet AMD should be confirmed with clinical examination and optical coherence tomography (OCT) imaging to assess fluid and retinal thickness
Management
- Consider intravitreal Axpaxli insert as a treatment option for treatment-naïve wet AMD patients to maintain visual acuity and control retinal fluid
- Follow an 8-week loading regimen prior to maintenance dosing as per SOL-1 trial protocol
Monitoring & Follow-up
- Monitor visual acuity and central subfield thickness regularly using ETDRS letter scoring and OCT imaging
- Assess for need of rescue therapy based on functional and anatomic changes
Risks
- Monitor for ocular adverse events although Axpaxli showed no treatment-related serious ocular events including endophthalmitis or retinal vasculitis in the trial
Patient & Prescribing Data
Treatment-naïve patients with neovascular AMD enrolled in the SOL-1 trial
Single intravitreal Axpaxli injection after loading showed higher rates of vision maintenance and fluid control versus aflibercept, with good tolerability and potential for predictable, durable disease control
Clinical Best Practices
- Prioritize anatomic control via OCT imaging as an early indicator of disease progression and future vision loss
- Utilize Axpaxli for sustained fluid control and visual acuity maintenance to potentially alter current wet AMD treatment paradigms
- Ensure safety monitoring consistent with intravitreal therapies, noting the favorable safety profile observed in SOL-1
References
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