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CNV reduced with ICON-1 treatment in phase 2 trial

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BOSTON — Choroidal neovascularization was reduced at 6 months in patients with age-related macular degeneration who were treated with ICON-1, according to a study presented here at the American Society of Retina Specialists meeting.

Christine R. Gonzales, MD, reported the results of the phase 2 EMERGE study of ICON-1 (Iconic Therapeutics), an anti-tissue factor immunoconjugate protein, being studied to determine its biological effect on choroidal neovascularization.

“The phase 2 trial is designed to evaluate the safety of repeated intravitreal injections of ICON-1 and to further explore the biological signals that we noted in the phase 1 trial,” Gonzales said.

The prospective, randomized, double-masked, active control study included 88 patients. Thirty patients received intravitreal injections of 0.3 mg ICON-1. Thirty patients received 0.3 mg of the study drug in combination with 0.5 mg Lucentis (ranibizumab, Genentech), and 28 patients received 0.5 mg ranibizumab monotherapy.

Three initial monthly injections were given and up to three additional injections were potentially given, as needed.

Primary endpoints included safety signals, as well as best corrected visual acuity and change in central retinal thickness (CRT). Outcomes were comparable in the combination arm and the ranibizumab control arm with regard to BCVA and CRT at months 3 and 6, she said.

“We did note a more favorable anatomic outcome in the combination group at 6 months compared to the ranibizumab group, with fewer re-treatments and a longer treatment-free interval,” she said. “This improved control of CNV was noted in terms of reduction of CNV area, greater proportion with complete drying of the retina and a greater proportion with resolution of sub-RPE fluid.”

There were no unexpected safety signals. – by Patricia Nale, ELS

Reference:

Gonzales CR. A phase 2 study (EMERGE) evaluating repeated intravitreal administration of ICON-1 in patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration. Presented at: American Society of Retina Specialists 35th Annual Meeting, Aug. 11-15, 2017; Boston.

Disclosure: Gonzales reports she is a consultant for and has received research and travel support from Iconic Therapeutics.