The FDA has rejected an investigational AbbVie drug for the “wet” form of age-related macular degeneration, dealing a setback to the company’s bid to wrest market share from blockbuster drugs currently used to treat the condition.
According to AbbVie (NYSE: ABBV), the FDA’s complete response letter states that the drug, abicipar pegol, caused a high rate of inflammation—a safety risk that the regulator concluded outweighs its benefits. The North Chicago, IL-based company said it plans to meet with the agency to discuss its comments and determine the next steps for the drug.
Age-related macular degeneration (AMD) causes blurriness and loss of focus in a person’s central vision. The “dry” form of the disorder is characterized by atrophy of a part of the eye called the macula. That form can progress to “wet” AMD, in which blood vessels grow in the area behind the retina and leak fluid. It’s also called neovascular AMD (nAMD).
Treatments for wet AMD include biologic drugs that block VEGF, a protein that contributes to blood vessel growth. Roche’s ranibizumab (Lucentis) and aflibercept (Eylea) from Regeneron Pharmaceuticals (NASDAQ: REGN) and Bayer are VEGF inhibitors that each generate blockbuster sales. But patients must receive these drugs via injections to the eye once a month or once every two months. Abicipar was developed for dosing once every three months, an easier regimen for patients.
The AbbVie wet AMD drug came to the company via its acquisition of Allergan, which worked with Molecular Partners to develop it. Abicipar emerged from Molecular Partners’ technology that makes biologic drugs based on natural proteins. The Swiss company says its proteins are smaller than a full-size antibody but are still able to bind to a target as well as an antibody drug can.
Eye inflammation is not a new problem for abicipar. In Phase 3 clinical trial results in 2018, Allergan and Molecular Partners reported that the drug showed efficacy comparable to treatment with ranibizumab. But the incidence of eye inflammation in the studies was markedly higher in the two groups dosed with abicipar compared to those who received ranibizumab.
Despite the FDA rejection, Michael Robinson, AbbVie’s vice president and global therapeutic area head of ophthalmology, says the company remains committed to the drug.
“We continue to believe in the need for treatment options that provide patients with reliable vision gains and less frequent dosing for the treatment of nAMD,” he said in a prepared statement.
AbbVie isn’t the only company trying to grab a piece of the AMD market. This week, Johns Hopkins University spinout AsclepiX Therapeutics announced a $35 million Series A round of funding to advance its peptide drug for wet AMD—intended for once-a-year-dosing—to human tests.