In the phase 3b TALON clinical trial, Novartis announced that the two primary endpoints are superiority for brolucizumab in treatment interval duration and noninferiority in change in visual acuity. Secondary endpoints will examine durability and anatomical outcomes, including retinal fluid resolution and CST fluctuation, according to a Novartis statement.
TALON is a 64-week, two-arm, randomized double-masked study assessing the efficacy and safety of brolucizumab 6 mg compared to aflibercept 2 mg. The trial will use a treat-to-control regimen allowing physicians to extend treatment intervals up to 16 weeks based on response to disease.
TALON involves approximately 176 sites and almost 700 patients.
“The initiation of TALON underscores our confidence in brolucizumab as we reimagine the treatment journey for people with wet AMD and their caregivers,” Dirk Sauer, Development Unit Head, Novartis Ophthalmology, said in the statement. “Brolucizumab is a critical part of our continued dedication to delivering treatments that may help reduce the symptoms, burden and progression of eye diseases.”
More information can be found on clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT04005352