Samsara Vision, Inc. announced FDA approval to initiate a U.S.-based, PMA supplemental study to evaluate improvements in visual acuity and the safety of its SING IMT™ (Smaller-Incision New-Generation Implantable Miniature Telescope) in people living with late-stage AMD. The CONCERTO trial will recruit older adults living with stable (non-active neovascularization), bilateral central scotomas (blind spots) due to late-stage AMD and fovea-involving geographic atrophy or disciform scar to receive a SING IMT™ in one eye. Study participants, aged 65 and older, cannot have had previous cataract surgery in the study eye and must agree to post-operative rehabilitation and training.

Both the operative and the non-study eye will be assessed pre- and post-operatively over a 12-month period (across five visits). The CONCERTO trial will include up to twenty clinical sites across the United States.