Adverum Biotechnologies Inc (NASDAQ: ADVM) stock has cratered in reaction to a Suspected Unexpected Serious Adverse Reaction of hypotony (clinically-relevant decrease in ocular pressure).
The event was reported in the INFINITY Phase 2 trial evaluating ADVM-022 gene therapy to treat diabetic macular edema (DME).
The company said that a patient who received a high dose of their gene therapy experienced a loss of vision in a treated eye.
The patient was given a high dose (6 x 10^11 vg/eye) of ADVM-022, with a case of hypotony developing, characterized by a decrease in ocular pressure.
The company has immediately decided to unmask the 36-patient trial to determine if any other treated patients might have similar issues.
As of December 2020, the INFINITY study was fully enrolled, and all patients completed dosing of the single intravitreal (IVT) injection of ADVM-022.
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