Adverum Biotechnologies Halts Gene Therapy Development for Diabetic Macular Edema Due to Adverse Events

Adverum Biotechnologies Halts Gene Therapy Development for Diabetic Macular Edema Due to Adverse Events

For the inherited retinal disease (IRD) community, news from the broader ocular gene therapy landscape is always significant. While this specific development from Adverum Biotechnologies concerns diabetic macular edema (DME) and wet age-related macular degeneration (wet AMD)—conditions distinct from most IRDs—it underscores the complexities and challenges inherent in developing novel gene therapies for eye diseases. Understanding the progress and setbacks in related fields can offer valuable insights into the rigorous safety standards and scientific hurdles that all ocular gene therapies, including those for IRDs, must overcome to reach patients.

Adverum Biotechnologies has announced a significant shift in its clinical development plan for its investigational gene therapy candidate, ADVM-022 (now known as ixoberogene soroparvovec or Ixo-vec). The company will no longer pursue the development of ADVM-022 for diabetic macular edema (DME) due to adverse events observed in clinical trials.

Key Facts from the Development:

• Program Halted for DME: Adverum has ceased further development of ADVM-022 for diabetic macular edema (DME). This decision was made following a review of data from the INFINITY clinical trial.
• Adverse Events: The halt was prompted by a