Kodiak Sciences has announced follow-up outcomes from the APEX study, which showed sustained clinical effect of KSI-101 through week 20 in patients with macular oedema secondary to inflammation.
In the study, more than 90% of subjects achieved absence of intraretinal and subretinal fluid.
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Macular oedema secondary to inflammation comprises a heterogeneous group of severe retinal diseases that threaten vision, characterised by visual impairment and macular oedema caused by disruption of the blood-retinal barrier and inflammatory processes.
Current treatment options are often limited by tolerability issues and side effects, underscoring the need for effective and safer alternatives.
KSI-101 is an investigational antibody-based therapy with a concentration of 100mg/mL. It employs a bispecific mechanism targeting vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6).
Participants in the trial were dosed at weeks zero, four, eight and 12. The therapy remained well tolerated with an encouraging safety profile.
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By GlobalDataKodiak Sciences chairman and CEO Dr Victor Perlroth said: “These week 20 follow-up results suggest even more strongly the potential for KSI-101 to become a cornerstone therapy for the treatment of macular oedema secondary to inflammation.
“The data show that achieving complete retinal drying, meaningful visual acuity gains and normalisation of visual acuity is possible for most patients with macular oedema secondary to inflammation. Most importantly, we can achieve this with a safe profile.”
The company concluded enrolment in its dose-finding Phase Ib APEX study, which is designed to assess KSI-101 in two groups.
Cohort 1 includes subjects with diabetic macular oedema and Cohort 2 will evaluate the therapy in patients with macular oedema secondary to inflammation.
The two highest dose levels from APEX, KSI-101 at 5mg and 10mg, have progressed to Phase III PEAK and PINNACLE pivotal studies, which are currently in the process of actively enrolling participants.
