Abstract
Adverum Biotechnologies acknowledged that a patient lost sight in the eye that was treated in a Phase II trial with the company's lead gene therapy candidate ADVM-022 (AAV.7m8-afiibercept) for diabetic macular edema (DME).
The company announced that the patient developed hypotony with panuveitis and loss of vision in the treated eye 30 weeks after the patient was randomized to receive a single intravitreal injection of the high dose (6 x 10^11 vg/eye) of ADVM-022.
Adverum said it responded to the Suspected Unexpected Serious Adverse Reaction (SUSAR) “in the interests of patient safety” by immediately unmasking the Phase II INFINITY trial (NCT04418427) to better understand what happened, “and to help identify and manage any similar potential risk to other patients in this study.” The INFINITY trial has been evaluating two doses of a single intravitreal injection of ADVM-022 gene therapy—either a high dose 6 x 10^11 vg/eye or low dose 2 x 10^11 vg/eye.
