Strategic statistical consulting for vision-critical devices
BSC delivers regulatory-ready statistical strategies for ophthalmic devices, addressing FDA's specific expectations for visual endpoints and bilateral data. Our approach minimizes regulatory risk while maximizing your clinical evidence's persuasive power.
Opthamology
Overview
BSC provides statistical expertise for ophthalmic devices and therapeutics, including intraocular lenses (IOLs), refractive surgery systems, glaucoma treatments, and retinal disease management technologies. Our experience spans both surgical and diagnostic ophthalmology devices.
Specialized Capabilities
Visual acuity endpoint design (ETDRS, logMAR). Handling of inter-eye correlation in bilateral studies. Non-inferiority margin justification for ophthalmic devices. Intraocular pressure modeling for glaucoma devices. Retinal imaging endpoint assessment.
Regulatory Experience
We understand ophthalmology division expectations for vision endpoint assessment, including appropriate vision testing protocols, handling of fellow-eye effects, and long-term safety monitoring for implantable devices. Our team has successfully navigated discussions around appropriate comparators and study designs.
Representative Studies
Intraocular lenses, IOLS, (monofocal, multifocal, toric)
Glaucoma drainage devices and minimally invasive procedures
Laser refractive surgery systems
Retinal treatment devices and drug delivery systems
Ophthalmic diagnostic imaging devices