Objective:
To evaluate the safety, efficacy, and immunogenicity of switching from reference aflibercept to the biosimilar MYL-1701P in patients with diabetic macular edema.
Approach:
- Study Design: An open-label extension of the phase 3 INSIGHT trial involving 52 patients who completed the 52-week trial and required continued anti-VEGF therapy.
- Patient Groups: 29 patients continued MYL-1701P, while 23 switched from reference aflibercept to MYL-1701P.
- Treatment Administration: All patients received three additional 2 mg intravitreal injections over 20 weeks.
- Endpoints: Primary endpoint was safety assessed by treatment-emergent adverse events; secondary endpoints included immunogenicity, BCVA, CST, and visual acuity letter gains.
Key Findings:
- Treatment-emergent adverse events occurred in 9 of 29 patients continuing MYL-1701P and 7 of 23 patients who switched.
- Most adverse events were mild or moderate; no deaths reported.
- One serious adverse event (cerebral infarction) occurred in the switch group, possibly related to treatment.
- No treatment-induced or treatment-boosted antidrug antibodies or neutralizing antibodies were detected.
- Visual and anatomic improvements from the parent trial were maintained through week 76.
Interpretation:
Switching from reference aflibercept to MYL-1701P did not present new safety or immunogenicity signals.
Limitations:
- Open-label design.
- Enrollment from a single geographic region.
- Relatively small study population.
- Limited number of postswitch exposures.
Conclusion:
The efficacy, safety, and immunogenicity profile of the switch arm was consistent with continuous MYL-1701P therapy.
Sources:
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