Shares in the company fell over 51% after a patient lost vision in one eye after a high dose of gene therapy ADVM-022.
The vision loss occurred 30 weeks after initial treatment with a single intravitreal injection of the gene therapy, when the patient developed increased ocular pressure, inflammation, and loss of vision in the treated eye. The ADVM-022 phase II trial, known as INFINITY, comprises 36 patients with diabetic macular edema, and dosing was completed in December 2020.
Adverum has now announced its intention to immediately unmask the study in order to understand the event, and to identify and manage any similar risks to other patients. The company is also conducting a review of the data from the program and plans to report the findings.
“The safety of every patient who is participating in our clinical studies with our gene therapy is the utmost priority for us at Adverum,” said Laurent Fischer, chief executive officer of Adverum, in a press 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 (DMC), scientific advisory board, and healthcare authorities.”