Samsara Vision to Initiate a US PMA Supplemental Study of the SING IMT, a New-Generation Technology for AMD

Samsara Vision announced FDA approval to initiate a US-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 postoperative 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 20 clinical sites across the United States.

“What’s exciting about this new technology is that the SING IMT procedure is performed with a preloaded delivery system, which is designed to ensure consistent, predictable insertion of the device using a smaller corneal incision—an important innovation the company developed since first introducing its novel, FDA approved telescopic implant,” said Marc H. Levy, MD, a neuro-ophthalmologist and orbital surgery specialist at the Sarasota Retina Institute and a CONCERTO study investigator and surgeon.

“People living with late-stage AMD face a reduced quality of life and isolation as their impaired vision prevents them from engaging in the activities of daily living and significant unmet treatment needs remain. At Samsara Vision, we’re focused on bringing innovative, high-performance micro-optical devices to market that offer people living with severe vision disorders, like late-stage AMD, sustainable vision improvements,” said Hayley McKee, PhD, Vice President, Worldwide Clinical and Medical Affairs.

SING IMT – Innovation for Late-Stage AMD

Nearly invisible inside the eye, the SING IMT is a Galilean style telescope implant designed to improve visual acuity and quality of life for patients with late-stage AMD. It is implanted during typical, out-patient cataract surgery with a corneal incision range between 6.5 mm to 7.5 mm. Images seen in “straight-ahead” vision are magnified 2.7x and projected onto healthy, undamaged areas of the macula in the back of the eye, reducing the impact of the AMD “blind spot” on central vision. Already, the SING IMT is approved for late-stage AMD patients who are 55 years of age or older in CE Referenced Countries, but it is not currently FDA approved in the United States.

“The CONCERTO trial initiation advances our goal to bring our novel and life-changing technology to our United States-based ophthalmology partners and their patients,” said Thomas Ruggia, chief executive officer at Samsara Vision. “Clinical studies are the foundation of advancing medical breakthroughs. We look forward to sharing results from CONCERTO and working closely with the FDA to determine a timely pathway to bring the SING IMT to market in the United States.”

The Implantable Miniature Telescope for AMD

Samsara Vision’s first-generation device, the Implantable Miniature Telescope (IMT) by Isaac Lipshitz, was first approved in 2010 and has been implanted in more than 600 patients. The SING IMT has identical ultra-precision micro-optics employing first-of-kind bi-convex and bi-concave convergent and divergent micro-lenses, coupled with air lenses that combined with the patient’s cornea create a magnified image onto healthy retinal tissue surrounding the degenerated macula. In previous clinical studies, 90% of IMT-implanted eyes achieved at least a 2-line gain or better in either distance or near best-corrected visual acuity (BCVA) at 12 months, sustained to 24 months. Quality of life (NEI-VFQ-25) scores were also improved by clinically significant levels.

The IMT is not a cure for late-stage AMD. It will not return vision to the level a patient had before AMD, nor will it completely make up for vision loss. The most common risks of the IMT and SING IMT surgery include inflammatory deposits or precipitates on the device and increased intraocular pressure. Significant adverse events include corneal edema, vision-impairing corneal edema, corneal transplant, and decrease in visual acuity. There is a risk that having the telescope implantation surgery could worsen your vision rather than improve it. Individual results may vary.