Adverum unmasks phase 2 DME trial after patient loses vision
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 therapy is the utmost priority for us at Adverum,” Laurent Fischer, MD, CEO of Adverum, said in the release. “We are fully committed to thoroughly assessing this case and ongoing monitoring of this patient and all patients treated with ADVM-022 with our investigators, data monitoring committee, scientific advisory board and health care authorities.”
Adverum has unmasked the study to investigate the event while managing risk for other patients in the trial, the release said.
INFINITY enrolled patients to receive a high dose or low dose (2 × 1011 vg per eye) injection of ADVM-022. Enrollment and patient dosing concluded in December 2020.
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