This article is more than 5 years old. Information may no longer be current.
AKB-9778, anti-VEGF combination therapy yields favorable results in TIME-2 trial
Click Here to Manage Email Alerts
WAIKOLOA, Hawaii — AKB-9778 in combination with an anti-VEGF agent for the treatment of patients with diabetic macular edema yielded favorable results in the phase 2 TIME-2 study, according to a speaker here.
“TIME-2 results support future development of AKB-9778 in combination with anti-VEGF therapy for the treatment of DME,” Peter K. Kaiser, MD, said at Retina 2016.
Peter K. Kaiser
In the TIME-2 clinical trial, 46 patients with DME were treated with AKB-9778 (Aerpio Therapeutics), 47 patients were treated with Lucentis (ranibizumab, Genentech), and 48 patients were treated with a combination of AKB-9778 and ranibizumab.
AKB-9778 alone did not affect retinal thickness, but the combination with ranibizumab significantly reduced central subfield thickness.
At month 3, central subfield thickness increased 6 µm in the AKB-9778 group, decreased 110 µm in the ranibizumab group and decreased 164 µm in the combination group, Kaiser said.
“There was a pretty consistent improvement in terms of the combination patients vs. those patients receiving ranibizumab alone, so it is not one or two patients that is driving that first analysis,” he said.
At 3 months, 11.4% of patients in the combination group had greater than a two-step improvement on the diabetic retinopathy severity scale compared with 10% in the ranibizumab group and 8.8% in the AKB-9778 group.
“We looked at the fellow eye to see if we saw a similar effect, and the fellow eye effect was almost identical in terms of more than a two-step change in reduction in diabetic retinopathy severity score, which is what is clinically relevant,” Kaiser said.
AKB-9778 is the first systemic product to demonstrate clinical benefit in combination with an anti-VEGF agent in DME, he said.
“A phase 3 study still needs to be done,” Kaiser said. – by Nhu Te
Reference:
Kaiser PK. Steroids for diabetic macular edema. Presented at: Retina 2016; Jan. 18-22, 2016; Waikoloa, Hawaii.
Disclosure: Kaiser reports he is a consultant for Aerpio Therapeutics and Regeneron.