Benzinga | Apr 29, 2021 05:32AM EDT

Adverum's Stock Crashes After DME Gene Therapy Trial Derails On One Patient's Serious Adverse Event

* 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.

* Price Action: ADVM shares crashed 47.6% at $5.32 in the premarket session on the last check Thursday.