Over the weekend at Euretina, Novartis announced its TALON trial, a phase 3b study evaluating brolucizumab vs aflibercept in two primary endpoints. 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 study, which involves approximately 176 sites and almost 700 patients, uses a treat-to-control regimen that allows physicians to extend treatment intervals up to 16 weeks based on response to disease.
Phase IIIb TALON clinical trial’s two primary endpoints are superiority for brolucizumab in treatment interval duration and non-inferiority in change in visual acuity. Secondary endpoints will examine durability and anatomical outcomes, including retinal fluid resolution and CST fluctuation.
Dirk Sauer, Development Unit Head, Novartis Ophthalmology said, “The initiation of TALON underscores our confidence in brolucizumab as we reimagine the treatment journey for people with wet AMD and their caregivers. Brolucizumab is a critical part of our continued dedication to delivering treatments that may help reduce the symptoms, burden and progression of eye diseases.”
The study is summarized in ClinicalTrials.gov:
“The study is a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with nAMD (neovascular age related macular degeneration) who have not previously received anti-VEGF (vascular endothelial growth factor) treatment. Patients who consent will undergo screening assessments to evaluate their eligibility based on the inclusion and exclusion criteria.”
Clinical trial information: https://clinicaltrials.gov/ct2/show/NCT04005352