A suspected unexpected serious adverse reaction has occurred in the phase 2 INFINITY trial investigating ADVM-022 gene therapy for the treatment of diabetic macular edema, according to a press release from Adverum Biotechnologies.
The event occurred 30 weeks after randomization in a patient treated with a single high-dose intravitreal injection, the release said. The patient developed “hypotony, with panuveitis and loss of vision in the treated eye.” The dose was 6 × 1011 vg per eye.
“The safety of every patient who is participating in our clinical studies with our gene