Patients with diabetic macular edema who switched from reference aflibercept to the biosimilar aflibercept MYL-1701P maintained safety, efficacy, and immunogenicity profiles comparable to those of patients who continued MYL-1701P during a 20-week extension of the phase 3 INSIGHT trial.
The open-label extension enrolled 52 patients from 15 sites in India who completed the 52-week global INSIGHT trial and continued to require intravitreal anti–vascular endothelial growth factor therapy. Twenty-nine patients continued MYL-1701P, while 23 switched from reference aflibercept to MYL-1701P. All patients received three additional 2 mg intravitreal injections over 20 weeks, with follow-up through week 76 of the parent study. The primary endpoint was safety, assessed by treatment-emergent adverse events, while secondary endpoints included immunogenicity, best-corrected visual acuity (BCVA), central subfield thickness (CST), and visual acuity letter gains. Forty-six patients completed the extension.
Treatment-emergent adverse events occurred in 9 of 29 patients who continued MYL-1701P in 7 of 23 patients who switched from reference aflibercept. Most events were mild or moderate, and no deaths were reported. One serious adverse event, cerebral infarction, occurred in the switch group and was considered possibly related to treatment. Ocular adverse events occurred with comparable frequencies between the treatment groups.
No treatment-induced or treatment-boosted antidrug antibodies or neutralizing antibodies were detected during the extension study. Investigators also found comparable immunogenicity profiles between the continuation and switch groups throughout follow-up.
The visual and anatomic improvements achieved during the parent trial were maintained through week 76. Changes in BCVA and CST remained comparable between patients who continued MYL-1701P and those who switched from reference aflibercept. Likewise, the proportions of patients gaining at least 5, 10, or 15 Early Treatment Diabetic Retinopathy Study letters were generally similar between groups, although investigators noted expected numerical differences at individual visits because of the small sample size.
The researchers acknowledged several limitations, including the open-label design, enrollment from a single geographic region, the relatively small study population, and the limited number of postswitch exposures. They noted that these factors should be considered when interpreting the findings despite the consistency of the extension results with those of the parent phase 3 trial.
Overall, the findings suggest that switching from reference aflibercept to MYL-1701P may maintain functional and anatomic improvements in patients with diabetic macular edema without new safety or immunogenicity signals during an additional 20 weeks of follow-up.
“The efficacy, safety and immunogenicity profile of the switch arm was consistent with the continuous MYL-1701P therapy,” wrote lead study author Rohan Chauhan, of Rising Retina Clinic, Ahmedabad, India, and colleagues.
Disclosures: The study was funded by Biocon Biologics Limited. Several authors reported financial relationships with Biocon Biologics, Viatris, and other ophthalmology companies.
Source: BMJ Open Ophthalmology
