Clinical Scorecard: How Vorolanib Could Shift the DME Landscape

At a Glance

Key Highlights

• Phase 2 VERONA trial showed vorolanib intravitreal insert (EYP-1901) extended time to first supplemental anti-VEGF treatment compared to aflibercept.
• Vorolanib demonstrated clinically meaningful BCVA improvements (~7 letters gain) and CST reduction (>75 µm) at 24 weeks after a single injection.
• Vorolanib is delivered via a sustained-release intravitreal insert with zero-order kinetics, providing continuous drug release for at least 6 months.

Guideline-Based Recommendations

Diagnosis

• Diagnosis of DME should include assessment of best-corrected visual acuity (BCVA) and central subfield thickness (CST) via OCT.

Management

• Initial treatment in the VERONA trial included a single aflibercept injection followed by vorolanib intravitreal insert or sham.
• Supplemental anti-VEGF injections are administered based on prespecified criteria including BCVA reduction and CST increase.
• Vorolanib may be considered for sustained-release treatment to reduce injection frequency.

Monitoring & Follow-up

• Monthly follow-up visits to assess BCVA and CST changes.
• Supplemental treatment criteria include BCVA loss of 5-9 letters with CST increase >75 µm on two consecutive visits, BCVA loss ≥10 letters, or CST increase ≥100 µm from baseline.
• Starting at week 12, lack of ≥10% CST reduction from baseline is also a criterion for supplemental treatment.

Risks

• Vorolanib intravitreal insert demonstrated a favorable safety profile with no ocular or systemic serious adverse events reported in over 190 patients.

Patient & Prescribing Data

Patients with previously treated diabetic macular edema

A single intravitreal injection of vorolanib insert can provide extended durability with 73% of patients in the 2.7 mg arm remaining free of supplemental treatment at 24 weeks, and vision gains sustained over this period.

Clinical Best Practices

• Use a single initial aflibercept injection followed by vorolanib insert to evaluate durability and efficacy.
• Monitor patients monthly with BCVA and OCT to guide supplemental anti-VEGF treatment decisions.
• Consider vorolanib’s intracellular VEGF receptor inhibition as complementary to extracellular anti-VEGF therapies.
• Leverage sustained-release intravitreal inserts to potentially reduce treatment burden and injection frequency.
• Evaluate patient adherence and visit attendance closely, as missed visits may impact visual outcomes.

References

• VERONA Phase 2 Clinical Trial Data
• EyePoint Pharmaceuticals Press Release on VERONA Results