Innovent phase 2 wet AMD treatment trial meets primary endpoint 

Key Takeaways

• Patients with wet AMD experienced visual benefits and anatomic improvements in a phase 2 clinical trial of IBI302. 
• Most patients who received IBI302 were able to extend dosing to every 12 weeks.

Neovascular age-related macular degeneration, (also known as wet AMD), is a condition where abnormal blood vessels grow beneath the macula, leading to rapid vision loss. IBI302 (efdamrofusp alfa) is a first-in-class therapy that targets both vascular endothelial growth factor (VEGF), a signal protein produced by cells that stimulates the formation of new blood vessels, and a part of the immune system called the complement system that is thought to play a role in the pathogenesis of AMD.  It is delivered through injection into the vitreous, a space in the back of the eye that is filled with a jelly-like fluid. 

In a second phase 2 clinical trial of IBI302, 132 Chinese patients were randomly assigned to receive IBI302 6.4 mg, IBI302 8 mg, or the anti-VEGF drug aflibercept 2 mg. Dosing intervals for IBI302 were adjusted depending on the response to the loading therapy.

Patients in the trial experienced visual benefits and anatomic improvements with IBI302, according to a press release from Innovent Biologics. This result was achieved with extended dosing intervals of IBI302. Eighty-one percent of patients in the 6.4 mg group and 88% of patients in the 8 mg group were able to extend dosing to every 12 weeks. Based on this, Innovent added an every 16 week dosing interval regimen to the phase 3 STAR clinical study of IBI302 8 mg. 

The safety profile of IBI302 was favorable, and the study identified no new safety signals (adverse effects of a treatment).

Edited by Suditi Kedambadi and Miriam Kaplan, PhD

Source: Healio Ocular Surgery News, March 22, 2024; see source article