Objective:
To evaluate the safety and efficacy of tiespectus (MK-8748) in patients with branch retinal vein occlusion (BRVO) as part of the phase 1/2a RIOJA trial.
Approach:
- Study Design: An open-label dose-escalation study enrolling 12 treatment-naïve patients with macular edema secondary to BRVO, with four ascending-dose cohorts (1 mg, 4 mg, 7 mg, and 10 mg).
- Treatment Administration: Patients received intravitreal injections every 4 weeks for a total of 3 doses, with dose escalation proceeding only after safety assessments.
Key Findings:
- All dose levels were well tolerated with no drug-related safety concerns.
- Mean best-corrected visual acuity (BCVA) improved by 16.7 ETDRS letters at week 12.
- Mean central subfield thickness (CST) decreased by 157.8 µm across all dose cohorts.
- Improvements in vision and retinal anatomy were observed as early as 1 week after treatment.
Interpretation:
The study primarily aimed to evaluate safety, but significant improvements in visual acuity and retinal structure were noted.
Limitations:
- The study involved a small sample size of 12 patients.
- Long-term durability and efficacy assessments are ongoing.
Conclusion:
Tiespectus shows promise as a dual-pathway inhibitor for retinal vascular diseases, with ongoing studies in neovascular age-related macular degeneration (nAMD).
Sources:
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