Samsara Vision Announces First US Surgeries of the SING IMT for AMD as Part of the CONCERTO Study

Samsara Vision announced the completion of the first US surgeries of its SING IMT (Smaller-Incision New-Generation Implantable Miniature Telescope), as part of the CONCERTO clinical study, a US-based FDA study to evaluate improvements in visual acuity and safety of the device in people living with late-stage AMD. David RP Almeida, MD, MBA, PhD, from Erie Retinal Surgery (PA), and Marc H. Levy, MD, from the Sarasota Retina Institute (FL), performed the first procedures using the SING IMT in late June.

“The SING IMT procedure represents a potential technological leap forward and the surgery, using the preloaded delivery system, allowed for not only a smaller corneal incision, but also a consistent and predictable insertion of the device,” Dr. Levy said in a company news release.

The CONCERTO trial will recruit 100 adults aged 65 and older 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. In addition, candidates cannot have had previous cataract surgery in the study eye and must agree to postoperative comprehensive visual rehabilitation and training.

“The surgery went well. I’m pleased that the SING IMT telescopic micro-optical device allows for ease of insertion and centration. It's wonderful to see the excitement of eligible phakic patients with severe vision loss and—as these patients adapt and learn to use their new vision during visual rehabilitation—I believe we will see a significant interest and demand for this important intervention," Dr. Almeida said.

“It’s highly encouraging that our first surgeries went smoothly. We look forward to working with the eye health community across the country during the CONCERTO study. Our goal is to bring our new technology to people blinded by late-stage AMD across the United States,” said Thomas Ruggia, CEO at Samsara Vision. “We intend to work closely with the FDA to determine a timely pathway to bring the SING IMT to market in the United States.”

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 apparent impact of the AMD “blind spot” on central vision.

To learn more about the CONCERTO study, visit www.concertostudy.com.