14 May Will Second Sight Medical Products Hit the Bull’s-Eye with Orion®?
Second Sight Medical Products, Inc. (NASDAQ: EYES), a developer of leading-edge implantable visual prosthetics, announced the results from a two-year study evaluating the feasibility of the Orion Visual Cortical Prosthesis (Orion).
The Orion® Visual Cortical Prosthesis System is a next-generation device that provides artificial vision to individuals suffering from blindness caused due to glaucoma, diabetic retinopathy, optic nerve injury or disease, or forms of cancer and trauma among others. The device can be implanted on the surface of the brain’s visual cortex and provides cortical stimulation by converting images captured by a miniature camera into electrical pulses, which are transmitted to an array of electrodes and provide light perception.
The results of the study held at UCLA and Baylor College of Medicine, which is a single arm study with six subjects enrolled, demonstrate that the majority of the participants benefited from the ORION. Out of the 6 subjects, five were able to locate a white square on a dark computer screen and four out of five were able to identify the direction of motion of a bar moving across a computer screen, significantly better with the Orion System on.
In addition, two subjects who were evaluated on the Functional Low-Vision Observer Rated Assessment (FLORA) were assessed as receiving mild positive or positive benefit in the real-world setting. The evaluation will continue for another 2 years and though there was only one serious adverse event during the early stages of the study, the same was resolved without hospitalization as per the Company.
Jessy Dorn, Vice President of Clinical and Scientific Research at Second Sight commented,
“We are excited to resume the study and see such promising results, especially after all visits were paused for several months due to COVID-19.”
Furthermore, the Company has received notice from the National Institutes of Health (NIH) intimating the release of year three funding of $1.4 million of the $6.4 million planned five-year grant for the ORION Trial. The funds from the trial will be utilized for paying UCLA and Baylor College of Medicine and supporting the continuation of the ORION trial.
Argus® II, the Company’s legacy product is an FDA approved electrical stimulation device for the retina, intended for patients with severe to profound retinitis pigmentosa, which has been implanted in 350+ individuals worldwide.
Second Sight Medical Products, Inc. (NASDAQ: EYES)
Market Cap: $ 143.45M; Current Share Price: 5.14 USD
Data by YCharts
Industry
The global ocular implants market size which was valued at USD 10.24 billion in 2016 is projected to grow at a CAGR of 6.7 percent from 2018 to 2025 as per a report by Grand View research. The rising incidences of glaucoma, diabetic retinopathy, trauma injuries and AMD are likely to drive the growth in the market. The advancement in science and technology has resulted in improved treatment options such as intraocular lenses, corneal implants, orbital implants, glaucoma implants, ocular prosthesis among others, which restore sight and sense of visual perception to a great extent.
The CDC’s Vision Health Initiative estimates that there are nearly 12 million people over the age of 40 who have vision impairment, including 1 million who are blind. In addition, over 4.2 million Americans suffer from uncorrectable vision impairment and the number is likely to double by 2050 due to growing incidence of diabetes, old age and other chronic diseases. According to an estimate, the direct cost of vision loss in North America is over $512.8 billion, and the indirect costs were $179 billion.
The American Academy of Ophthalmology defines cataract as the clouding of the lens through which light rays are refracted and is characterized by blurry or unclear vision, double images, sensitivity to light, difficulty in seeing well at night and seeing dull or faded color instead of natural colors. The growing geriatric population, improved life efficiency, chronic conditions such as diabetes and prolonged exposure to sun are some of the causes for growth in the number of cataracts.
Macular Degeneration is caused by the age-related deterioration of the central portion of the retina named Macula. Macula is responsible for focusing the central vision in the eye and regulates reading, driving, facial and color recognition abilities. It collates the images from the center of the field of vision, and sends it to the optic nerves, so that it can be relayed to the brain. Macular degeneration is characterized by wavy or blurred vision and loss of central vision eventually, though peripheral vision may still be working fine.
The disease is the leading cause of vision loss for people over 60 years in the U.S, affecting an estimated 11 million people in the United States, and is likely to reach epidemic proportions by 2050, affecting over 22 million Americans, in the absence of research and treatment breakthroughs.
Company
The Company has over 20 years of experience in creating cutting-edge neurostimulation devices for those with vision impairment. Second Sight has created the world’s first FDA approved and CE Mark device that provides artificial vision to people with late-stage retinitis pigmentosa (RP).
Second Sight is currently working on developing a cortical stimulation device that is capable of bypassing a diseased eye and provide vision to those who are visually impaired due to causes such as glaucoma, diabetic retinopathy, optic nerve injury or disease, or forms of cancer and trauma among others. The Company’s work is based on the partnership of Dr. Sam Williams, who suffered from retinitis pigmentosa and pioneering medical philanthropist Dr. Alfred Mann. The partnership was later extended to include Dr. Robert Greenberg, Aaron Mendelsohn and Gunnar Bjorg.
The Company achieved its first regulatory approval in 2011 and followed it up with an FDA approval in 2013 for its unique technology that was able to provide vision to people suffering from retinitis pigmentosa.
Argus®II is a Retinal Prosthesis System that combines a miniature eye implant along with a patient-worn camera and processor to provide the ability to interpret light patterns, identify basic outlines and shapes and provide easy mobility to those who are visually challenged. Second sight achieved the 100th Argus® II Implant in 2016 and followed it up with its +300th Argus®II Implant in 2018. The device also factors in programming flexibility and has provision for future hardware and software upgrades.
Key Takeaways
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
Click here to please visit our detailed disclosure
References
https://finance.yahoo.com/news/second-sight-medical-products-announces-100000099.html
https://www.grandviewresearch.com/industry-analysis/retinal-implant-market
https://www.massdevice.com/second-sights-merger-with-pixium-vision-may-fall-through/
No Comments