Samsara Vision has announced positive intermediate-term visual and safety results from the implantation of the Smaller-Incision New-Generation Implantable Miniature Telescope (SING IMT) in late-stage age-related macular degeneration (AMD) patients six months post-surgery.
According to the company, the implantation demonstrated significant improvements in both distance and near vision, with manageable safety outcomes and minimal impact on corneal endothelium cell density.
The study reported substantial gains in best-corrected distance visual acuity (BCDVA), with 97.1%, 68.6%, and 51.4% of operated eyes experiencing at least one, two, and three-line improvements, respectively.
The subjects’ ability to read at a near distance increased from 28.6% at baseline to 97.1% at six months. Corrected near visual acuity also improved by approximately three lines after surgery.
The retrospective study, which supported the use of implantation in CE Mark-referenced countries, involved 35 subjects aged 55 years or older.
The patients were treated at the University Federico II in Naples, or the Policlinico Gemelli Hospital in Rome, Italy.
Subjects underwent a rehabilitation programme to “optimise” visual outcomes, which included eight 90-minute sessions over six months. The programme focused on enhancing various visual skills.
The study also found no significant changes in intraocular pressure or anterior chamber depth, with the mean change in corneal endothelial cell density at six months being -280.7 cells/mm².
Samsara Vision CEO and president Thomas Ruggia said: “Already, 19 CE-referenced countries have implanted the SING IMT in more than 400 patients, with greater than 63% of surgeons performing multiple procedures, signalling increasing physician confidence and enthusiasm for the procedure.
“We’re gratified that this study confirms the effectiveness and safety of the SING IMT and believe our novel device will become the standard of care for patients blinded in their central vision by AMD.”
SING IMT is approved for subjects aged 55 years and older in CE-referenced countries and is under investigation in the US.
