Adverum Halts Phase II Gene Therapy Trial After Patient’s Vision Loss

Slated to begin a Phase III later this year of ADVM-022 in wet AMD, Adverum had to scuttle a Phase II study of the gene therapy in DME after a patient suffered ocular hypotension, panuveitis and vision loss in the treated eye.

Adverum's significant adverse event is the latest setback in gene therapy development

The timing of a planned Phase III of Adverum Biotechnologies, Inc.’s gene therapy ADVM-022 in wet age-related macular edema (AMD) is in doubt after the company revealed on 28 April that it halted a Phase II study of ADVM-022 in diabetic macular edema (DME) following one patient losing vision in one eye.

The AMD trial was slated to begin in late 2021.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

Chinese Biotechs Sweep ADC Plus PD-(L)1/VEGF Bispecific Combos Into Phase II

 

Chinese firms Junshi, Minghui and RemeGen rank among the world’s few players progressing antibody-drug conjugates combined with PD-(L)1/VEGF bispecific antibodies in Phase II trials for various cancers.

Alkermes To Advance Alixorexton After Positive Phase II Narcolepsy Results

 

The biotech company is planning for Phase III based on positive topline results from Vibrance-1 in narcolepsy type 1 and remains optimistic about type 2 disease.

Pipeline Watch: Five Approvals And Twelve Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Genentech Gets Columvi Complete Response Following ODAC’s No

 
• By 

Seeking to move Columvi into second-line DLBCL, Genentech got an FDA letter saying the Phase III STARGLO study’s benefits may have been driven by results in Asian enrollees.

More from R&D

Genentech Gets Columvi Complete Response Following ODAC’s No

 
• By 

Seeking to move Columvi into second-line DLBCL, Genentech got an FDA letter saying the Phase III STARGLO study’s benefits may have been driven by results in Asian enrollees.

BMS’s Reblozyl Misses Primary Endpoint In Myelofibrosis Anemia

 

The drugmaker announced topline results from the Phase III INDEPENDENCE trial, which did meet key secondary endpoints.

Insmed’s New R&D Site Focused On ‘Synthetic Rescue’

 

A new small-molecule approach to turning on beneficial genes to counteract disease-causing mutations is being pioneered by Insmed’s UK-based scientists.