SING IMT Device Secures Positive 6-Month Data for Late-Stage AMD

Intermediate-term assessment of visual and safety outcomes found the implantation of the Smaller-Incision New-Generation Implantable Miniature Telescope (SING IMT) benefited distance and near vision in patients with late-stage age-related macular degeneration (AMD) at 6 months post-surgery.1

Announced by Samsara Vision on January 13, 2025, and simultaneously published in the journal Heliyon, the company indicated SING IMT demonstrated a low impact on corneal endothelium cell density (ECD), with an acceptable and reasonable level of complications and adverse events.

“This six-month review highlights the potential of SING IMT to restore meaningful vision to individuals blinded by AMD, while preserving long-term corneal health with its innovative design,” co-author Mario Damiano Toro, a professor in the eye clinic in the department of public health at the University of Naples Federico II, said in a statement.2

Late-stage AMD is typically linked to advanced neovascular (wet) AMD (nAMD) or any geographic atrophy (GA), representing the most common cause of severe vision loss in older individuals across developed countries.3 Approximately 11 million people in the US are affected by AMD, with nearly 2 million experiencing advanced forms of AMD, and the number is expected to double to 22 million by 2050.

SING IMT is an intraocular telescope designed to benefit the visual performance of patients with central vision loss due to AMD.1 The device has been approved for use in patients aged ≥55 years without previous cataract surgery in CE-Referenced countries in the European Union (EU) and is under investigation in the US.

This retrospective cohort study of SING IMT included 35 patients aged ≥55 years (mean age, 77.4 years) with late-stage AMD treated at two sites in Italy. Patients participated in a necessary rehabilitation program starting 6 weeks after surgery to strengthen skills, including visual abilities, reading, writing, visual motor integration, and mobility.

Outcomes measured at 6 months post-surgery included best-corrected distance (BCDVA) and distance-corrected near (DCNVA) visual acuity, intraocular pressure (IOP), anterior chamber depth (ACD), corneal ECD, and adverse events.

Analysis 6 months post-surgery showed the mean ± standard deviation change in BCDVA from baseline was –0.29 ± 0.142. Toro and colleagues identified at least 1-, 2-, and 3-line gains in BCDVA in 97.1%, 68.6%, and 51.4% of the operated eyes (n = 35), respectively.

Further analysis found the number of patients able to read at near distance expanded from 28.6% at baseline to 97.1% at 6 months post-surgery, for a mean improvement of –0.57 ± 0.206. Corrected near visual acuity also significantly improved by ~3 lines post-surgery, according to Samsara Vision.

Safety findings revealed no clinically meaningful change from baseline in intraocular pressure (IOP) or anterior chamber depth (ACD), with a 6-month mean change of –280.7 cells/mm2 (–11.4%) in corneal ECD. Most adverse events, including corneal edema (22.9%), were resolved by 6 months with topical medications.

Samsara Vision indicated some device-related events, including iris damage and pigment deposits, continued over time, but the overall safety profile of SING IMT implantation was acceptable. The company noted there is no cure for late-stage AMD and the SING IMT device does not completely make up for the loss of vision due to AMD.2

“We will continue monitoring these patients to ensure their improved vision translates into a better quality of life and enhanced daily functioning,” co-author Alfonso Savastano, a professor at La Libera Università Mediterranea, said in a statement.2

Samsara Vision cited the 19 CE-referenced countries in the EU that have implanted SING IMT in more than 400 patients, pointing to more than 63% of surgeons performing multiple procedures. The company indicated an increase in physicians' confidence in implantation marks a broader 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,” Thomas Ruggia, president and chief executive officer of Samsara Vision, said in a statement.2

References

1. Toro MD, Savastano A, Aroca F, D’Onofrio N, Costagliola C, Rizzo S. Smaller-incision new-generation implantable miniature telescope in late-stage age-related macular degeneration: 6 month outcomes. Heliyon. January 15, 2025. Accessed January 14, 2025. https://www.cell.com/heliyon/fulltext/S2405-8440%2824%2917147-2?
2. Samsara Vision announces positive six-month visual and safety outcomes from the SING IMT® (smaller-incision new-generation implantable miniature telescope). Samsara Vision, Inc. January 13, 2025. Accessed January 14, 2025. https://www.samsaravision.com/press-releases/detail/73/samsara-vision-announces-positive-six-month-visual-and.
3. Chaudhuri M, Hassan Y, Bakka Vemana PPS, Bellary Pattanashetty MS, Abdin ZU, Siddiqui HF. Age-Related Macular Degeneration: An Exponentially Emerging Imminent Threat of Visual Impairment and Irreversible Blindness. Cureus. 2023;15(5):e39624. Published 2023 May 29. doi:10.7759/cureus.39624