LAUSANNE, Switzerland, April 6, 2016 /PRNewswire/ --
Second Sight Medical Products, Inc. (Nasdaq: EYES) ('Second Sight'), a developer, manufacturer and marketer of implantable visual prosthetics to restore useful vision to blind patients, announces today that, following a positive recommendation from health professionals who advise the UK Government's healthcare funding authority for specialized services in England, a Public Consultation on a new policy on the NHS funding of Argus II for patients suffering with Retinitis Pigmentosa has been issued.
The Public Consultation allows stakeholders including would-be and previously implanted Argus II patients, doctors and blindness charities the opportunity to comment on a new draft policy to fund the treatment through NHS England, in order that severely blind patients in England can have access to a technology that is now available in many other parts of Europe. These stakeholders have 30 days to comment on the draft policy guidance. The draft policy can be found at: https://www.engage.england.nhs.uk/consultation/clinical-commissioning-wave8.
The Public Consultation on the new policy follows a positive recommendation based on the efficacy, safety, quality of life benefit and cost-effectiveness of the Argus II Retinal Prosthesis by the Clinical Reference Group for Specialized Ophthalmology Services, a group of senior healthcare professionals who advise NHS England on the benefit of funding new specialist services for eye disease, and the Rare Diseases Advisory Group which advises NHS England on treatments for uncommon conditions.
Following the 30-day consultation period, the draft policy will be reviewed. The draft policy proposes that Argus II is not funded routinely, and suggests that Argus II will instead be funded under the Commissioning through Evaluation (CtE) programme. This is usually recommended when NHS England believes a treatment can offer clinical benefits but wants to collect more evidence on the best way to realize those benefits. The new evidence is used when the initial policy is reviewed. CtE funding is allocated for a defined period and involves collecting more detailed data on the outcomes of treatment than is typical in health care. Other countries have similar funding programs under which a new promising technology is made available to patients while being further evaluated, such as the "Forfait Innovation" (national innovation funding) program in France under which Argus II has been reimbursed since 2014. The Argus II has been also available and reimbursed for patients in USA, Germany and parts of Italy for the past two years.
If as a result of the consultation, Argus II is recommended for funding under the CtE programme, NHS England's Clinical Priorities Advisory Group, chaired by Sir Nick Partridge, makes recommendations to NHS England's Directly Commissioned Services Committee on the prioritisation and commissioning of new services. Following this, the Board of NHS England makes the final decision on whether, how and when to fund the treatment.
Grégoire Cosendai, VP of Europe for Second Sight Medical Products, Inc, says: "Second Sight is delighted by this very positive development. This is a pivotal moment in our six-year mission to make Argus II available in the NHS in England.
"The contribution of English patients and English surgeons was key to our success in having Argus II approved and funded elsewhere in Europe and in the USA. It is right that RP patients who have not been treated in England, should have access to this technology like patients elsewhere in the world.
"We fully support the CtE program, and look forward to working with the NHS on this life changing initiative for RP patients in the UK."
Professor Paulo Stanga, Consultant Ophthalmologist & Vitreoretinal Surgeon, Manchester Royal Eye Hospital, University of Manchester and Manchester Vision Regeneration (MVR) Lab at NIHR/Wellcome Trust Manchester CRF, says: "I have worked in ophthalmology for 25 years and the Argus II has been one of the most successful technologies I have worked with during this time. Having been working with and implanting Argus II patients myself since 2009, I have seen at first hand how beneficial and life changing this technology has been to people with no other treatment options. We depend so heavily on visual clues, so it is reassuring and life affirming for a person who is completely blind to experience the visual world that surrounds them, using this system. For the first time, perhaps in decades, they don't feel isolated. For patients' families, it is also a life changing treatment, because their loved ones are less dependent."
Lyndon da Cruz, MD PhD, Consultant Retinal Surgeon at Moorfields Eye Hospital NHS Foundation Trust, says: "I welcome this consultation on a new policy on the NHS Funding of Argus II. As a surgeon who has trialled this treatment, I have seen first-hand the positive outcomes it can have for patients. If the treatment is made available on the NHS in England, it will bring hope to the many patients with profound vision loss from Retinitis Pigmentosa, who could experience the real, and, in some cases, life changing, benefits of the prosthesis."
Notes to editors:
- The Argus II® Retinal Prosthesis System (RPS) is the world's only routinely implanted, stable, effective photoreceptor replacement device implanted for life for severely blind patients.
- A cost effectiveness analysis of Argus II carried out by NHS England has shown that its cost per Quality Adjusted Life Year (QALY), when taken over the remaining lifetime of a patient, is £11,000 - £24,000, well under the NICE threshold of £20,000 - £30,000 for recommending new treatments for funding in the NHS (and even further below the higher threshold NICE can use for rare diseases).
- NHS England considers that the Argus II clinical data shows that, on average, patients with the Argus II RPS activated had an improved visual acuity from Bare Light Perception (only being able to see if the light is on or off) to at least Hand Motion detection, and possibly Counting Fingers, when the RPS was active.
- In the first group, 29 of 30 subjects (97%) successfully achieved localisation tasks. In the second group, 16 of 30 subjects (57%) successfully achieved motion discrimination tasks, in addition to the localisation tasks. In the third group 7 of 30 subjects (23%) achieved a repeatable acuity score with a grating visual acuity test, again in addition to improvements in both localisation and motion discrimination tasks.
- The improvement in functional vision was large and approximately twice as big as a clinical meaningful change, based on data collected on a benchmark of 3,000 visually challenged subjects with variable visual impairment.
About the Argus® II Retinal Prosthesis System
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 are intended to stimulate the retina's remaining cells, resulting in the perception of patterns of light in the brain. The patient then learns to interpret these visual patterns, thereby regaining some visual function. The Argus II is the first artificial retina to receive widespread approval. It is offered at approved centers in Canada, France, Germany, Italy, the Netherlands, Saudi Arabia, Spain, Switzerland, Turkey, the United Kingdom and the US.
About Second Sight
Second Sight's mission is to develop, manufacture and market innovative implantable visual prosthetics to enable blind individuals to achieve greater independence. Second Sight developed and manufactures the Argus® II Retinal Prosthesis System. Enrollment has been completed in a trial to test the safety and utility of the Argus II in individuals with Dry Age-Related Macular Degeneration. Second Sight is also developing the Orion™ I Visual Cortical Prosthesis to restore some vision to individuals who are blind due to causes other than preventable or treatable conditions. US Headquarters are in Sylmar, CA, and European Headquarters are in Lausanne, Switzerland. For more information, visit http://www.secondsight.com
Toll-free number: UK 0800-520-0925
Safe Harbor
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange and Exchange Act of 1934, as amended, which are intended to be covered by the "safe harbor" created by those sections. All statements in this release that are not based on historical fact are "forward looking statements." These statements may be identified by words such as "estimates," "anticipates," "projects," "plans," or "planned," "seeks," "may," "will," "expects," "intends," "believes," "should," "potentially," "objectives," and similar expressions or the negative versions thereof and which also may be identified by their context. While management has based any forward looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our Annual Report on Form 10-K as filed on March 11, 2016 and our other reports filed from time to time with the Securities and Exchange Commission. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
Gloucester Road Communications UK
Amanda Hayhurst
Amanda@amandahayhurst.com
Tel: +44(0)772-0205581