gms | German Medical Science

Since 1995 a subretinal implant for blind patients with retinitis pigmentosa has been developed in Germany, first supported by public research funds and as of 2003 by private investors. After 3 clinical trials (Zrenner et al. 2011; Stingl et al. 2015, 2017) the RETINA IMPLANT Alpha AMS with 1600 pixel and approximately 5 years of life time received the CE mark in 2016, was registered as medical device on the market, and reimbursed by the public health care system in Germany. Further centers in UK, France and Italy had started to establish this treatment within their national health care system. Thirty patients have received the RETINA IMPLANT Alpha AMS produced and distributed by Retina Implant AG (Reutlingen, Germany). Unfortunately, the economic potential achievable with today's electronic retinal implants in the small market of the rare disease retinitis pigmentosa (RP) is not enough for a viable economic perspective. Thus commercial returns were insufficient for the continuation of Retina Implant AG (Reutlingen, Germany). As a result, the development, production and supply to hospitals of Retina Implant Alpha AMS has been discontinued in March 2019 and Retina Implant AG has concluded its business activities. Production of the epiretinal Implant ARGUS II, developed and marketed by Second Sight (Sylmar CA, USA) has been stopped as well, according to press releases. Nevertheless, continuing care for patients who have received retinal implants in recent years will be provided by clinical partners. We see several reasons for such developments:

1.

After many clinical studies, numerous implantations and demanding visual training, it is now clear that the expectations of most candidates for electronic implants cannot be met regarding the improvement of visual quality and the associated everyday benefits. Improvements of visual functions by today’s retinal implants for handling activities of daily living are considered by most interested patients as too small. Although some patients with Retina Implant Alpha were able to read letters and words (Zrenner et al. 2011) and even identify facial expressions, only a fraction of patients (40%-50%) had some benefit in typical daily living tasks (Stingl 2015, 2017). Preoperatively it cannot be predicted what patients will be the ones who will benefit.

2.

Regulatory processes take too long in implementing lab-tested technical improvements into modified devices approved for marketing. Even small modifications require clinical trials with high financial commitments.

3.

Achieving coverage of costs for retina implant surgery by health care insurance systems is different and cumbersome in each and every country. Although binding general contracts are in place with the central association of all German public health insurances the individual insurance of the patient hesitates to accept cost coverage for the recommended treatment.

4.

Alternative solutions are provided by the rapidly increasing number of convenient and easy to handle smartphone apps that translate visual tasks into information accessible to blind people especially dedicated to daily living tasks.

5.

All of the above requires readiness for investors to face relatively high risks – with financial returns not to be expected for many years.

6.

Time consumption and complexity of retinal surgery is demanding and needs to be reduced significantly.

It has become clear that for continued market success retinal implants need to be improved considerably to meet the expectations of patients, ophthalmologists, investors and health care insurances. Main functional requirements are: larger visual fields, a higher spatial resolution, an improved contrast, and a higher number of simultaneously discernible gray levels, ideally including chromatic information. Equally important are protocols for the electrical stimulation of the degenerating and continuously remodeling retina to provide long-term stable and reliable perceptions throughout the