Adverum has made the decision to scrap its gene therapy ADVM-022 in DME citing dose-limiting toxicity. In April, Adverum reported that a patient in its Phase 2 DME trial who received a high dose of the therapy had developed decreased ocular pressure, major inflammation and loss of vision in the treated eye.
Adverum has now disclosed that, despite close monitoring and aggressive treatment, five other recipients of the high dose suffered rapid, clinically relevant drops in intraocular pressure. These events occurred 16-36 weeks after treatment with the high dose
. The cases did not respond to steroids and required additional treatment. Three of the five patients required surgery to correct the pressure issue.
After Adverum's toxicity event was reported in April,
Evaluate suggested that it raised the question of why patients would take the risk of gene therapy for eye disease.
.Adverum Provides Update on ADVM-022 and the INFINITY Trial (globenewswire.com)https://www.fiercebiotech.com/biotech/gene-therapy-toxicity-drives-adverum-to-stop-dme-development
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