Life-Saving Eye Technologies; TechBullion Q&A Interview With Thomas Ruggia, President and CEO, Samsara Vision

My name is Thomas Ruggia, and I am the President and CEO of Samsara Vision since July 2020. Samsara Vision was a great fit given my nearly two decades of experience in the ophthalmology business, with a focus on developing and commercializing vision products, domestically and internationally.

Before joining Samsara Vision, I spent five years at Johnson  & Johnson as Vice President WW Customer Experience and Ocular Surface Disease, where I led global commercial teams in customer strategy and service. I also spent fourteen years at Alcon, a division of Novartis, in various sales and marketing roles, progressively advancing in responsibility. My commitment to disruptive thinking and embracing challenges continues to drive my leadership and innovation at Samsara Vision.

Tell us more about Samsara Vision and the unique solutions you provide?

At Samsara Vision, our mission is to help our patients reconnect to the people and activities in life that they love through improved vision. Our primary technology is the Smaller-Incision, New Generation Implantable Miniature Telescope (SING IMT®), already approved in key global markets, and under investigation in the United States, for late-stage, age-related macular degeneration (AMD). The SING IMT® offers meaningful innovations compared to our first device, the Implantable Miniature Telescope (IMT), the first and only U.S. Food and Drug Administration (FDA) approved intraocular device demonstrated to improve vision and quality of life for people with late-stage AMD. 

Unlike other companies that focus on treatments that may slow the progression of AMD, we aim to restore vision. Our approach involves careful patient selection, a simple outpatient procedure followed by necessary low-vision therapy. We’ve seen patients return to activities they love, such as playing cards, painting, and reading. They are seeing the faces of their grandchildren and friends. The SING IMT® has already been used in over 350 procedures in Europe by 100 retina or cornea surgeons in 17 countries of whom 60 percent have completed multiple procedures, signaling adoption of the technology.

Could you give us an insight into the Implantable Miniature Telescope (IMT) market, the technology behind this innovation and why this is in demand?

A 2017 study published in JAMA Ophthalmology revealed that a large number of AMD cases go undetected and undiagnosed in the primary eye care setting. This is a problem because AMD is the leading cause of irreversible visual loss in the United States, with variable degrees of age-related macular changes occurring in more than 10 percent of the population aged 65-74 years and 25 percent of the population older than 74 years. As many as 20 million people in the United States have some form of age-related macular degeneration and we estimate that around eight million are potential candidates for our device. 

Our approach at Samara Vision includes working collaboratively with health care providers, researchers, payers, and advocates to ensure that people living with late-stage AMD have access to our novel technologies and support paths thereby better ensuring a future where they can see anew. We estimate that the Treatable Addressable Market (TAM) is worth $40B, which will double in the event that our device is approved in the future for pseudophakic patients, or those who already have an artificially implanted lens following cataract surgery. The device is not available to those patients, presently. 

The SING IMT® is a Galilean intraocular telescope designed to improve visual acuity and quality of life for patients with late-stage AMD. The design improves upon a 1st-generation miniature telescope device implanted in more than 600 patients in that it has a new foldable haptic design that enables enhanced stability and centration during the out-patient procedure. In addition, there is a new Tsert SI™ delivery system, which is designed to ensure consistent, predictable delivery of the device. Combined, this reduces the length of the surgical procedure and the number of sutures, which hastens recovery.

How it works is that while using natural eye movements, images seen in straight-ahead, central vision are projected and enlarged 2.7 times onto healthy photoreceptors surrounding the macula in the back of the eye. This reduces the impact of the AMD “blind spot” in central vision and allows patients to see images that may have been unrecognizable before.

While there are traditional external optical or video magnifiers that can help to enlarge vision at a particular distance or for a single activity, there is nothing like the SING IMT® that allows people to use their new vision for seeing things at all distances and for performing multiple activities in ways similar to natural vision. 

Eligible patients undergo out-patient surgery in only one eye, while the other remains as is to preserve that eye’s peripheral vision. Importantly, 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 also 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. 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.

Congratulations on the successful launch of the SING IMT® in Europe. Tell us more about SING IMT®, the key milestones that Samsara Vision achieved during this process, some of the biggest challenges you faced during the development and launch of the SING IMT® in the European market, and how you overcame them?

Thank you! We’re thrilled about the successful launch of the SING IMT® in Europe. We focused on Europe due to the high prevalence of late-stage AMD in the region, aligning with our approach to prioritize areas with the greatest need.

During the launch process, we faced typical regulatory challenges, mostly related to medical device category characterization and pricing. We were able to overcome that obstacle by engaging in open, collaborative discussions, in which we emphasized mutual benefits and demonstrated the SING IMT’s positive impact on the patients’ quality of life. 

The European launch and practical implementation of our holistic treatment program that includes rehabilitation to promote functional vision use already has produced positive results that reinforce the SING IMT’s important place in the AMD treatment paradigm. For example a post-launch retrospective study published in Ophthalmology and Therapy found that the majority of patients with late-stage AMD monocularly implanted with the SING IMT® (n=11) had improved functional vision after participating in a 24-week rehabilitation program focused on real-world tasks such as reading, writing, visual motor integration and mobility. Reading speed nearly doubled between the first and the second to last session. This is important because reading performance is one of the best predictors of patient-reported visual ability and vision-related quality of life.

These results are an important follow-up to a study reporting 3-month Best Corrected Visual Acuity (BCVA) outcomes following the SING IMT® procedure. Notably, that study reports that improvements in device design (compared to the first-generation model) resulted in considerably lower endothelial cell density (ECD) loss while maintaining the visual acuity outcomes achieved with the first-generation device. 

In Europe, we’ve onboarded teams in Italy, Germany, France, and thirteen other countries to offer patients local options. Given how important the vision therapy is post-procedure, having geographic options for patients so that they can easily access their health care team is vital to ensure optimal outcomes in each patient. 

How does the SING IMT® differ from the earlier version of the IMT that has been available in the United States since 2010? What have been the most significant impacts or lessons from the European launch of SING IMT® that you plan to apply to the upcoming U.S. launch? 

The SING IMT® represents a significant advancement over the earlier versions of the IMT. One of the most notable improvements is the use of our Tsert SI, pre-loaded delivery system. This system allows for a much smaller incision size—approximately  7 mm—which is nearly half the size required for earlier procedures and requires only 3 sutures compared to 11-12, earlier. This smaller incision, along with the now foldable haptics on the telescope implant, enables a less invasive procedure. The outpatient surgery time has been dramatically reduced from about 60 minutes to approximately 30 minutes. Combined, the procedure is now more efficient and less burdensome for both patients and surgeons, and patients are noticing an effect days after the procedure as their eye heals more quickly. 

From our European launch, we’ve learned that the reduced procedural time and smaller incision have shown significant benefits in patient recovery and overall satisfaction. This will help guide our strategy in the U.S., as we work closely with the FDA to bring our technology to American patients. We want to offer them the most cutting-edge solutions to improve their vision and quality of life.

Key to success will be identifying and training surgeons in the United States because we are using a surgery that was originally designed for the physiology of the front of the eye (cataract surgery technique) to treat a disease located in the back of the eye. 

Notably, the SING IMT® procedure will be covered by well covered by Medicare under the same existing code as our original device, which will remove a barrier to patients accessing the device.

In terms of regulatory hurdles, how does the process of bringing a medical device to market in Europe compare to that in the United States and how is Samsara Vision planning to educate and train ophthalmologists and optometrists in the U.S. about the benefits an proper implementation of the SING IMT®

Bringing a medical device to the market in the United States has different regulatory hurdles when compared to the European market. In Europe, the process involves obtaining a CE mark, which is more streamlined compared to the U.S. FDA approval process. The CE mark approval we received for the SING IMT® in 2020 allowed us to quickly introduce our innovative technology to the European market. Meanwhile, the FDA process in the U.S. is much more rigorous and can take longer due to requiring more extensive clinical trials and data requirements to ensure safety and efficacy. 

With that being said, we’re working with the FDA to submit a supplemental PMA, which allows us to add data to our existing file with the FDA, which approved our first-generation device.  We are actively working with the FDA to navigate this pathway and bring the SING IMT® to American patients as soon as possible through our ongoing CONCERTO trial.

To ensure the successful introduction of the SING IMT® in the U.S., we plan to focus on comprehensive education and training for ophthalmologists and cornea surgeons. This will include detailed training sessions, hands-on workshops, and digital resources that highlight the benefits and proper techniques for implanting the SING IMT®. Further, we’ll ensure that the surgeons and referring ophthalmologist have a network of low visions specialists trained to provide the rehabilitation required for patients to learn to use their new vision. Our goal is to equip the entire health care team with the knowledge and skills they need to provide the best care for patients with late-stage AMD, ensuring they can fully benefit from this groundbreaking technology. We believe that the SING IMT® will be an attractive treatment options for our U.S. providers given its improved ease of use and generous, existing Medicare reimbursement.

Can you share some success stories or patient testimonials from those who have used the SING IMT® in Europe and looking forward, what are Samsara Vision’s next steps and goals for the SING IMT® in the U.S. market?

When people lose their vision, they often become more isolated.

That’s why I’m constantly inspired to learn about how our patients use their new vision to reengage with their hobbies, families, and the activities important to them in daily living. Consider this accomplishment: We have a Greek patient whose central vision was completely blocked, but now he can watch English language movies and read the closed captions. The words update rapidly against a constantly changing background, but he can follow along. This may seem like a small change, but for someone who was unable to see much straight ahead, it’s a life-changing improvement. We’ve got patients who are reading, watching TV, dancing with their partners, painting, and more. They can open their front door and safely see who is on the other side. Even something as simple as picking out ripe fruit at the market stand is easier and more enjoyable with improved central vision. 

In the United States, we are actively recruiting patient candidates for the CONCERTO trial and invite people to visit the website to determine if their loved one might be a candidate. Upon completion, we will share the data with the FDA and apply for the device to be approved for use, hopefully in 2026. 

Do you have any available opportunities for investors and partnerships at Samsara Vision, are there any specific timelines or milestones you aim to achieve? 

While Samsara Vision is backed by a private equity firm, we are actively speaking with investors, seeking to raise capital to support our U.S. trials, addition European expansion, expansion in China through our partnership with Lansheng Medical, and a possible label expansion to include patients who have previously undergone cataract surgery, which is presently contraindicated and would effectively double our addressable target market. Our goal is to achieve FDA approval in the U.S. by 2026, with commercialization possible that same year.

How do you envision the future of Samsara Vision in the broader ophthalmic device industry, and what role do you see the SING IMT® playing in the treatment of untreatable retinal disorders globally?

Too often, companies focus on improving existing technologies. However, incremental changes are risk averse and neglect areas where investment in true innovation can change lives.

At Samsara Vision, we believe that our novel intraocular telescope will play a pivotal role in transforming the treatment landscape for late-stage AMD globally. As we expand our reach in Europe and work towards FDA approval in the U.S., our goal is to establish the SING IMT® as the standard of care. Soon, we will also launch clinical trials in China, expanding our global footprint. 

By continuing to push the boundaries of what’s possible in ophthalmic devices, we aim to rejuvenate eyesight and revive the spirit of countless individuals, enabling them to reconnect with the world around them.

Do you have more tips to share with our readers today?

Age-related macular degeneration has no cure. Despite the availability of vitamins, routine injections, and other treatments, inevitably some people progress to late-stage AMD where they are blinded in their central vision. At Samsara Vision, our innovative technology provides a treatment option that upends what people thought was possible. We’re excited that we can help patients see what is important to them and will work hard to improve access to our remarkable device around the world. I invite you to learn more at 

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