Adverum Biotechnologies has announced a Suspected Unexpected Serious Adverse Reaction (SUSAR) of hypotony (clinically-relevant decrease in ocular pressure) in its Infinity clinical trial evaluating ADVM-022 gene therapy for the treatment of diabetic macular edema (DME). This event occurred 30 weeks after randomisation in one patient treated with a single intravitreal injection of the high dose (6 x 10^11 vg/eye) of ADVM-022 who has developed hypotony, with panuveitis and loss of vision in the treated eye.
In the interests of patient safety, Adverum has decided to immediately unmask the Infinity Phase II study to better understand this event and to help identify and manage any similar potential risk to other patients in this study, which completed patient dosing in December 2020. Additionally, the company is conducting a thorough review of data from the ADVM-022 program and plans to report its findings as the analysis progresses.
“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. “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.”
Image credit: Chris Curry