QL1207 (aflibercept biosimilar) / Qilu Pharma - LARVOL DELTA

A Clinical Study of QL1207H Injection Versus Aflibercept for Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P3 | N=356 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Biosimilar QL1207 Demonstrates Equivalent Efficacy and Safety in DME (Center for Biosimilars) - "The study found no statistically significant differences between groups in BCVA or CRT at baseline or at 1, 3, 6, or 12 months. Both groups demonstrated significant improvement in BCVA relative to their own pretreatment values, as well as substantial reductions in CRT (P < .05 for all within-group comparisons). At 12 months, mean CRT decreased from 447.1 µm to 280.4 µm in the reference group and from 441.0 µm to 290.3 µm in the QL1207 group. Injection burden was also similar, with mean injection counts of 3.58 in the reference group and 3.40 in the biosimilar group (P = .272)....Safety outcomes were consistent with the known safety profile of intravitreal anti-VEGF therapy."

Real-world • Diabetic Macular Edema

Efficacy and Safety of Biosimilar QL1207 vs. the Reference Aflibercept for Patients with Neovascular Age-Related Macular Degeneration: A Randomized Phase 3 Trial. (PubMed, Ophthalmol Ther) - P3 | "QL1207 has equivalent efficacy to aflibercept for nAMD with similar safety profiles. It could be used as an alternative anti-VEGF agent for clinical practice."

Clinical • Journal • P3 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study to Compare QL1207 to Eylea® in Subjects With Wet Age-related Macular Degeneration (wAMD) (clinicaltrials.gov) - P3 | N=366 | Completed | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration