Business Wire12.05.17
Second Sight Medical Products Inc., a developer, manufacturer, and marketer of implantable visual prosthetics that are intended to create an artificial form of useful vision to blind patients, has received U.S. Food and Drug Administration (FDA) Expedited Access Pathway designation for the Orion Cortical Visual Prosthesis System (Orion). This designation is given to a few select medical devices in order to provide more effective treatment of life-threatening or irreversibly debilitating diseases or conditions. This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review.
The FDA has also released a draft guidance document for a Breakthrough Devices Program, which, when finalized, will supersede the Expedited Access Pathway. FDA has indicated that all devices which have EAP designation will gain Breakthrough Device designation when the guidance document is finalized.
With this designation, Orion will have the following advantages during the FDA review process:
“These advantages potentially allow the FDA to approve Orion with fewer patients and with a shorter follow-up timeline, thus facilitating a faster entry of Orion into the commercial market. We are delighted about the opportunity for patients to have expedited access to Orion, once approved,” stated Will McGuire, president and CEO of Second Sight.
Second Sight Chairman Dr. Robert Greenberg added, “FDA’s Expedited Access Pathway is a game changer for nearly all blind individuals in the U.S. who currently have no treatment options. We look forward to moving the program ahead and working with the FDA in the coming months to map out the most efficient path to market for this therapy, which has the potential to treat most causes of blindness.”
Blind patients interested in the Orion clinical trial can contact Second Sight customer service at 855-756-3703 for further information or referral to a clinical trial site.
A proof-of-concept clinical trial at UCLA demonstrating the viability of stimulation of the human visual cortex with a commercially available device from a different manufacturer was announced in Q4 2016. First-in-human clinical studies with the Orion are planned to begin in 2017.
Like the Argus II, the idea behind Second Sight’s Orion is to convert images captured by a miniature video camera mounted on the patient's glasses into a series of small electrical pulses. The Orion is designed to transmit these electrical pulses wirelessly to an array of electrodes implanted on the surface of the visual cortex, intended to result in the perception of patterns of light. By bypassing the retina and optic nerve and directly stimulating the visual cortex, a cortical prosthesis system has the potential to restore useful vision to patients completely blinded due to many reasons, including glaucoma, diabetic retinopathy, or forms of cancer and trauma—many fold more patients than for the current Argus II indications. No clinical data is yet available for the Orion.
Second Sight's Argus II System provides electrical stimulation that bypasses the defunct retinal cells and stimulates remaining viable cells inducing visual perception in individuals with severe to profound Retinitis Pigmentosa. The Argus II works by converting images captured by a miniature video camera mounted on the patient's glasses into a series of small electrical pulses, which are transmitted wirelessly to an array of electrodes implanted on the surface of the retina. These pulses stimulate the retina's remaining cells, intending to result in the perception of patterns of light in the brain. The patient must learn to interpret these visual patterns, having the potential to regain some visual function. The Argus II was the first artificial retina to receive widespread commercial approval, and is offered at approved centers in Canada, France, Germany, Italy, Russia, Saudi Arabia, South Korea, Spain, Taiwan, Turkey, the United Kingdom, and the United States.
Second Sight's mission is to develop, manufacture and market implantable visual prosthetics to enable blind individuals to achieve greater independence. Second Sight has developed, and now manufactures and markets the Argus II Retinal Prosthesis System. Enrollment has been completed in a feasibility trial to test the safety and utility of the Argus II in individuals with dry age-related macular degeneration. New hardware and software to improve the quality of the vision produced is underway. A clinical trial to study the Argus II in better-sighted subjects earlier in the disease was recently approved in Germany. Second Sight is also developing the Orion Visual Cortical Prosthesis to restore some vision to individuals who are blind due to causes other than preventable or treatable conditions. The company's U.S. headquarters is in Sylmar, Calif., and its European headquarters is in Lausanne, Switzerland.
The FDA has also released a draft guidance document for a Breakthrough Devices Program, which, when finalized, will supersede the Expedited Access Pathway. FDA has indicated that all devices which have EAP designation will gain Breakthrough Device designation when the guidance document is finalized.
With this designation, Orion will have the following advantages during the FDA review process:
- Greater interactive review both for the Investigational Device Exemption and Premarket Approval application;
- Greater reliance on post-market vs. pre-market data collection and greater acceptance of uncertainty in the benefit-risk profile at the time of approval;
- Priority review (i.e., review of the submission is placed at the top of the review queue and receives additional review resources); and,
- Senior FDA management involvement and assignment of a cross-disciplinary case manager
“These advantages potentially allow the FDA to approve Orion with fewer patients and with a shorter follow-up timeline, thus facilitating a faster entry of Orion into the commercial market. We are delighted about the opportunity for patients to have expedited access to Orion, once approved,” stated Will McGuire, president and CEO of Second Sight.
Second Sight Chairman Dr. Robert Greenberg added, “FDA’s Expedited Access Pathway is a game changer for nearly all blind individuals in the U.S. who currently have no treatment options. We look forward to moving the program ahead and working with the FDA in the coming months to map out the most efficient path to market for this therapy, which has the potential to treat most causes of blindness.”
Blind patients interested in the Orion clinical trial can contact Second Sight customer service at 855-756-3703 for further information or referral to a clinical trial site.
A proof-of-concept clinical trial at UCLA demonstrating the viability of stimulation of the human visual cortex with a commercially available device from a different manufacturer was announced in Q4 2016. First-in-human clinical studies with the Orion are planned to begin in 2017.
Like the Argus II, the idea behind Second Sight’s Orion is to convert images captured by a miniature video camera mounted on the patient's glasses into a series of small electrical pulses. The Orion is designed to transmit these electrical pulses wirelessly to an array of electrodes implanted on the surface of the visual cortex, intended to result in the perception of patterns of light. By bypassing the retina and optic nerve and directly stimulating the visual cortex, a cortical prosthesis system has the potential to restore useful vision to patients completely blinded due to many reasons, including glaucoma, diabetic retinopathy, or forms of cancer and trauma—many fold more patients than for the current Argus II indications. No clinical data is yet available for the Orion.
Second Sight's Argus II System provides electrical stimulation that bypasses the defunct retinal cells and stimulates remaining viable cells inducing visual perception in individuals with severe to profound Retinitis Pigmentosa. The Argus II works by converting images captured by a miniature video camera mounted on the patient's glasses into a series of small electrical pulses, which are transmitted wirelessly to an array of electrodes implanted on the surface of the retina. These pulses stimulate the retina's remaining cells, intending to result in the perception of patterns of light in the brain. The patient must learn to interpret these visual patterns, having the potential to regain some visual function. The Argus II was the first artificial retina to receive widespread commercial approval, and is offered at approved centers in Canada, France, Germany, Italy, Russia, Saudi Arabia, South Korea, Spain, Taiwan, Turkey, the United Kingdom, and the United States.
Second Sight's mission is to develop, manufacture and market implantable visual prosthetics to enable blind individuals to achieve greater independence. Second Sight has developed, and now manufactures and markets the Argus II Retinal Prosthesis System. Enrollment has been completed in a feasibility trial to test the safety and utility of the Argus II in individuals with dry age-related macular degeneration. New hardware and software to improve the quality of the vision produced is underway. A clinical trial to study the Argus II in better-sighted subjects earlier in the disease was recently approved in Germany. Second Sight is also developing the Orion Visual Cortical Prosthesis to restore some vision to individuals who are blind due to causes other than preventable or treatable conditions. The company's U.S. headquarters is in Sylmar, Calif., and its European headquarters is in Lausanne, Switzerland.