Adverum Biotechnologies (ADVM) announced Suspected Unexpected Serious Adverse Reaction of hypotony in its INFINITY clinical trial evaluating ADVM-022

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Adverum Biotechnologies Provides Update on the INFINITY Trial Evaluating ADVM-022 in Patients with Diabetic Macular Edema

April 28, 2021 4:01 PM EDT

REDWOOD CITY, Calif., April 28, 2021 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM) 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... More