Samsara Vision Announces First Pseudophakic Surgery in the PERSPECTIVE Clinical Trial to Evaluate the Smaller-Incision New-Generation Implantable Miniature Telescope (SING IMT®) in Patients with Previous Cataract Surgery

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FAR HILLS, N.J.--(BUSINESS WIRE)--Oct 6, 2025--

Samsara Vision, a company focused on bringing vision and freedom back to patients with late-stage, age-related macular degeneration (AMD) through advanced visual prosthetic devices, today announced the initiation and the first surgery of the PERSPECTIVE clinical trial to evaluate the efficacy and safety of the Smaller-Incision New-Generation Implantable Miniature Telescope (SING IMT ® ) in pseudophakic patients. On September 30, 2025, Dr. John Conrath, a leading vitreoretinal and cataract surgeon at Centre Monticelli-Paradis, Marseille, France, conducted the first procedure.

Underway in CE referenced countries where the SING IMT ® is approved for use, surgeons participating in the PERSPECTIVE study are evaluating implantation of the SING IMT® in late-stage AMD patients with a previously implanted intraocular lens (IOL) used in cataract surgery. History of cataract surgery is currently contraindicated.

“Implanting the SING IMT in pseudophakic patients is just the beginning — structured visual rehabilitation is critical also for patients to adapt to their new vision,” said Dr. Conrath. “Through PERSPECTIVE, we aim to better understand how surgery and training together can restore meaningful function to patients with late-stage AMD.”

About PERSPECTIVE

PERSPECTIVE is a multicenter, randomized clinical trial being conducted across 3 CE referenced countries and is expected to enroll participants through 2026. The PERSPECTIVE study is the first of its kind to assess outcomes in pseudophakic eyes within a controlled, multinational setting. The inclusion of pseudophakic subjects is clinically significant because this subgroup represents a large proportion of individuals affected by late-stage AMD who are not eligible for any other interventions. The primary endpoints will assess safety, visual outcomes, patient selection criteria, and rehabilitation strategies.

“Most older adults experience immense benefits from routine cataract surgery with an intraocular lens implant. However, individuals with co-existing AMD who advance to late-stage disease with central vision loss, do not experience the same vision benefits from IOLs. Central vision restoration for these patients is a huge unmet medical need,” said Thomas Ruggia, CEO and president of Samsara Vision. “We’re excited to advance the PERSPECTIVE clinical trial to generate meaningful data to inform a possible label expansion so that we can offer our sight-enhancing device to many patients in CE referenced countries.”

To learn more about PERSPECTIVE, visit https://clinicaltrials.gov/study/NCT07164378

Addressing Unmet Treatment Needs in Late-Stage AMD

Age-related macular degeneration (AMD) is a leading cause of permanent vision loss for people age 50 and older, and the number one cause of blindness in people age 65 years and older. Approximately 67 million people in the European Union are affected by AMD and this number is expected to grow by 15 percent until 2050.

About SING IMT ®

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 for patients 65 years and older meeting specific eye health criteria. 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. Driving is contraindicated with the device. The most common risks of the SING IMT ® surgery include inflammatory deposits or precipitates on the device and increased intraocular pressure. Adverse events in the recent study include corneal edema, and one patient had a decrease in visual acuity. There is a risk that having the telescope implantation surgery could worsen vision rather than improve it. Individual results may vary.

About Samsara Vision

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 are intended to significantly improve vision and quality of life for individuals with untreatable retinal disorders. We believe that rejuvenating eyesight revives the spirit, allowing people to reconnect to the things in life that they love to see and do. Our approach includes working collaboratively with health care providers, researchers, payers, and advocates to ensure that people living with deteriorating vision have access to our novel technologies and support paths thereby better ensuring a future where they can see anew. Learn more at https://www.samsaravision.com.

Safe Harbor Statement

This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. Forward-looking statements include those about the potential benefits to be derived from the SING IMT™ and the intent to work closely with the FDA to determine a timely pathway to bring the SING IMT™ to market in the United States and the belief that rejuvenating eyesight revives the spirit, allowing people to reconnect to the things in life that they love to see and do. These forward-looking statements and their implications are based on the current expectations of the management of Samsara only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: claims by other companies and persons regarding ownership over intellectual property; changes in technology and market requirements; Samsara may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Samsara’s products may not be approved by regulatory agencies, Samsara’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Samsara may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Samsara’s process; Samsara’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Samsara’s patents may not be sufficient; Samsara’s products may harm recipients; changes in legislation may adversely impact Samsara; inability to timely develop and introduce new technologies, products and applications; the risk factors and uncertainties described in the Registration Statement on Form S-1, as amended (File No. 333-260742) filed with the U.S. Securities and Exchange Commission; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Samsara to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Samsara undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

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KEYWORD: NEW JERSEY UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: SCIENCE BIOTECHNOLOGY RESEARCH OPTICAL SURGERY HEALTH MEDICAL DEVICES CLINICAL TRIALS

SOURCE: Samsara Vision

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PUB: 10/06/2025 10:31 AM/DISC: 10/06/2025 10:32 AM

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