Press Release

Okuvision GmbH successfully completed the conformity assessment procedure in accordance with the EU Medical Device Regulation (MDR) for OkuStim® 2 on December 2, 2025. With the CE marking granted, the company confirms that the medical device meets current European requirements for safety and performance. OkuStim® 2 is a consistent evolution of the established OkuStim® system and enables patients to carry out transcorneal electrical stimulation independently at home. This therapy can slow the progression of visual field loss in Retinitis pigmentosa, thereby supporting the preservation of vision over a longer period. The CE marking, which required extensive technical and clinical evidence, marks an important milestone for the Reutlingen-based company.

OkuStim® 2: A new standard in the treatment of Retinitis pigmentosa

The medical device OkuStim® 2 is designed for the treatment of patients with Retinitis pigmentosa – one of the most common causes of progressive blindness in the working-age population, affecting approximately 1 in 4,000 people worldwide. No causative treatment is currently available.

“With OkuStim® 2, we are setting a new standard for the application of transcorneal electrical stimulation (TES),” says Dr. Alfred Stett, CEO of Okuvision GmbH. “The system combines technical precision with a consistent focus on the user and is an expression of our commitment to preserving the vision of people with degenerative retinal diseases for as long as possible. In addition to Retinitis pigmentosa, we see great potential for transcorneal electrical stimulation in the treatment of glaucoma and age-related macular degeneration.”

The OkuStim® 2 system consists of the programmable neurostimulator and the ultra-thin, silver-coated OkuEl® M electrodes. The neurostimulator impresses with its ergonomic design, which facilitates handling and underlines the high standards of precision and safety. OkuStim® 2 was awarded the German Design Award 2026 in Gold in the Medical, Rehabilitation and Healthcare category for this. Software-supported patient workflows simplify procedures in clinics and practices, while flexible settings for stimulation parameters and pulse shapes open up new possibilities for research and clinical trials in ophthalmology and neuromodulation.

TES: A guideline-compliant therapy option

As a form of physical therapy, transcorneal electrical stimulation works via a fine electrode filament placed on the lower eyelid. Weak electrical impulses are targeted at the eye to stimulate the retina. The individually adjustable current intensity – safely below one milliampere – ensures precise and controlled application. Typically, the therapy is performed once a week for 30 minutes in the home environment. Thus, the OkuStim® 2 system combines therapeutic precision with a high degree of safety and comfort for patients.

Transcorneal electrical stimulation is listed as a possible therapy option for Retinitis pigmentosa in the guidelines of the German Ophthalmological Society (DOG), the Professional Association of Ophthalmologists in Germany (BVA), and the Retinological Society (RG). Its long-term efficacy is currently being investigated as part of a multicenter Trial study (according to § 137e SGB V) commissioned by the Federal Joint Committee (G-BA) at 17 German eye clinics, in order to prepare for the inclusion of the treatment in the benefit catalog of statutory health insurance funds.

About Okuvision

Based in Reutlingen, Okuvision GmbH has been developing and manufacturing medical technology solutions to preserve visual function in degenerative retinal diseases since 2007. With the OkuStim® system, the company is considered a pioneer of transcorneal electrical stimulation in ophthalmology. Twenty specialized employees combine expertise from medical technology, neurobiology, ophthalmology, and regulatory affairs, pursuing a common goal: to preserve the vision of people with degenerative retinal diseases for as long as possible.