Positive Visual and Safety Outcomes Linked to Samsara’s SING IMT

Samsara Vision is reporting encouraging intermediate-term visual and safety outcomes with its SING IMT (Smaller-Incision New-Generation Implantable Miniature Telescope) in patients six months after surgery.

Overall, researchers found that SING IMT implantation improved distance and near vision in age-related macular degeneration patients, with a low impact on the corneal endothelium cell density and manageable safety outcomes. The results are published in the journal Heliyon.

At six months post-surgery, researchers found at least one-, two-, and three-line gains in best-corrected distance (BCDVA) were achieved in 97.1%, 68.6%, and 51.4% of operated eyes, respectively (n=35), with the mean ± standard deviation (SD) change in BCDVA from baseline – 0.29 ± 0.142. The percentage of patients able to read at near distance increased from 28.6% at baseline to 97.1% at six months. In addition to distance vision, the study also found that corrected near visual acuity also significantly improved by ⁓3 lines six months after surgery.

“Already, 19 CE referenced countries have implanted the SING IMT in more than 400 patients, with greater than 63% of surgeons performing multiple procedures, signaling increasing physician confidence and enthusiasm for the procedure,” Samsara Vision President/CEO Thomas Ruggia stated. “We’re gratified this study confirms the effectiveness and safety of the SING IMT and believe our device will become the standard of care for patients blinded in their central vision by AMD.”

Approved for use in CE Mark referenced countries, the retrospective SING IMT study included 35 patients (55 years or older) with late-stage AMD, treated at either the University Federico II in Naples, Italy, or the Policlinico Gemelli hospital in Rome, Italy. To optimize the visual outcomes, patients participated in a required rehabilitation program starting six weeks after surgery, attending eight 90-minute sessions every two-to-three weeks for six months. The program included exercises to strengthen skills such as visual abilities, reading, writing, visual motor integration, and mobility.

Notably, there was no clinically meaningful change from baseline in intraocular pressure or anterior chamber depth (ACD) and the mean (SD) change from baseline in corneal endothelial cell density (ECD) at six months in operated eyes was -280.7 (315.9) cells/mm2 (-11.4 %). Importantly, no new complications occurred between the three- and six-month follow-ups. Most expected adverse events, such as corneal edema (22.9%), resolved by six months with the use of topical medications, while some device-related events (e.g., iris damage, pigment deposits) persisted, indicating an acceptable safety profile for SING IMT implantation.

“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 design,” said professor Mario Toro, study co-author from University Hospital Federico II.

Among several studies published in 2024, was a pertinent one (small retrospective—[n=11]) published in Ophthalmology and Therapy that evaluated functional vision approvements following SING IMT implantation. The study reported significant improvement in real-world tasks such as reading, writing, visual motor integration and mobility, a key predictor of patient-reported visual ability and vision-related quality of life.

“We will continue monitoring these patients to ensure their improved vision translates into a better quality of life and enhanced daily functioning,” stated study co-author Prof. Alfonso Savastano, of Regional Hospital “F. Miulli”, Acquaviva delle Fonti (BA), Italy.

Age-related macular degeneration (AMD) is a leading cause of permanent vision loss for people age 50 and older, and the top cause of blindness in people age 65 years and older. As many as 11 million Americans are affected by some form of macular degeneration and this number will increase to 22 million by 2050. Nearly 2 million Americans have advanced forms of AMD with associated vision loss. Similarly, approximately 67 million people in the European Union are affected by AMD and this number is expected to grow 15% annually through 2050. While treatments exist to try to slow the progression of AMD, and there are assistive devices that can help people with reduced vision see better with magnification, many patients will progress in their disease. The SING IMT is an intraocular telescope approved for use in patients without previous cataract surgery and 55 years and older in CE Referenced countries and is under investigation in the United States.

There is no cure for late-stage AMD and the SING IMT does not return vision to the level a patient had before AMD, nor will it completely make up for vision loss.

Samsara Vision is a privately held specialty medical device company headquartered in the United States and engaged in the research, development, manufacture, and marketing of proprietary implantable ophthalmic devices and technologies that aim to significantly improve vision and quality of life for individuals with untreatable retinal disorders. The company works collaboratively with healthcare providers, researchers, payers, and advocates to ensure that people living with deteriorating vision have access to its technologies and support paths.