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Can Patients Switch to Biosimilar Aflibercept?
A 20-week INSIGHT extension suggests that switching from reference aflibercept to MYL-1701P maintained comparable safety, visual, and anatomic outcomes in patients with diabetic macular edema.
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.
Presenting results from the DME AWARE Delphi Study at the Association for Research in Vision and Ophthalmology (ARVO) meeting in Denver, Baruch D. Kuppermann, MD, PhD, director of the Gavin Herbert Eye Institute at the University of California, Irvine, described a set of consensus findings that point to unmet needs across the continuum of DME management, with particular emphasis on early intervention and noninvasive treatment options (Figure 1).
