Adverum Biotechnologies provides update on the INFINITY trial evaluating ADVM 022 in patients with diabetic macular edema.

Adverum Biotechnologies, Inc. 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 randomization 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 INFINITY study is evaluating two doses of a single intravitreal (IVT) 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. As of December 2020, the INFINITY study was fully enrolled, and all patients completed dosing of the single IVT injection of ADVM 022. All patients continue to be evaluated regularly during the monitoring phase of this study. Adverum is working closely with the DMC and the study sites to proactively develop additional recommendations for patient monitoring and management. All clinical trial sites, as well as the FDA, have been advised of this case. About the INFINITY Phase II Trial of ADVM 022 in DR/DME : INFINITY is a Phase II, multi-center, randomized, double-masked, active comparator-controlled trial designed to assess a single intravitreal (IVT) injection of ADVM 022 in patients with diabetic macular edema (DME), the most common cause of vision loss in patients with diabetic retinopathy (DR). The INFINITY trial enrolled 36 patients and is designed to demonstrate superior control of disease activity following a single IVT injection of ADVM 022 compared to a single aflibercept injection, as measured by time to worsening of DME disease activity. Participants in this double-masked trial were randomized to one of three arms for their study eye treatment: Arm 1 received high dose (6 x 10^11 vg/eye) of ADVM 022, Arm 2 received low dose (2 x 10^11 vg/eye) of ADVM 022, and Arm 3 received aflibercept at a dose of 2 mg. Additional objectives include assessments of treatment burden, visual acuity, retinal anatomy, and safety outcomes. For additional information about the INFINITY trial, please visit www.clinicaltrials.gov using Identifier NCT#04418427 or www.INFINITYclinicaltrial.com.