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

  • Adverum Biotechnologies Inc 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.

Posted In: Briefsgene therapyBiotechNewsHealth CareSmall CapFDAGeneral

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