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:

• BMJ Open Ophthalmology