A Comprehensive Guide to Clinical Investigations: Content and Modifications in the EU – MDCG Guidance

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Pixium Vision reveals findings from a 48-month trial on Severe Atrophic AMD

Pixium Vision, a leading company in the field of visual prosthetics, has recently unveiled the findings from a groundbreaking 48-month trial on Severe Atrophic Age-Related Macular Degeneration (AMD). This trial has provided valuable insights into the potential of Pixium’s innovative technology to restore vision in patients suffering from this debilitating condition.

Age-Related Macular Degeneration is a progressive eye disease that affects millions of people worldwide, particularly those over the age of 50. It is characterized by the deterioration of the macula, a small area in the center of the retina responsible for sharp and detailed vision. Severe Atrophic AMD is the most advanced stage of this disease, where the macula becomes severely damaged, leading to significant vision loss and impairment.

Pixium Vision’s trial aimed to evaluate the safety and efficacy of their novel visual prosthetic system, known as PRIMA, in patients with Severe Atrophic AMD. PRIMA is an implantable device that works by stimulating the remaining functional cells in the retina, bypassing the damaged macula and transmitting visual information to the brain.

The trial involved 10 patients with advanced AMD who had no remaining central vision. Over the course of 48 months, these patients underwent surgery to have the PRIMA device implanted in one eye. The device consists of a miniaturized wireless photovoltaic chip that is placed beneath the retina and connected to a pair of glasses equipped with a mini-camera.

The results of the trial were highly encouraging. The study demonstrated that PRIMA was safe and well-tolerated by all participants, with no serious adverse events reported. Moreover, the device showed promising efficacy in restoring visual perception in these patients. Over time, participants reported improvements in their ability to perceive light, shapes, and even recognize letters.

One of the most remarkable findings was that some patients were able to regain functional vision, allowing them to perform daily activities such as reading, recognizing faces, and navigating their surroundings. This breakthrough has the potential to significantly improve the quality of life for individuals suffering from Severe Atrophic AMD, who previously had no treatment options available to them.

Dr. Yannick Le Mer, Chief Scientific Officer at Pixium Vision, expressed his excitement about the trial’s results, stating, “We are thrilled with the outcomes of this 48-month trial. The PRIMA system has demonstrated its potential to restore visual perception in patients with Severe Atrophic AMD, offering new hope for those affected by this devastating condition.”

Pixium Vision’s PRIMA system represents a significant advancement in the field of visual prosthetics. While it is not a cure for AMD, it has the potential to provide a meaningful improvement in the quality of life for patients with severe vision loss. The company is now planning to conduct larger-scale clinical trials to further evaluate the safety and efficacy of the PRIMA system and seek regulatory approval for its commercialization.

In conclusion, Pixium Vision’s 48-month trial on Severe Atrophic AMD has revealed promising findings regarding the potential of their PRIMA visual prosthetic system. This innovative technology has shown to be safe and effective in restoring visual perception in patients with advanced AMD, offering new hope for those affected by this debilitating condition. With further research and development, Pixium Vision aims to bring this groundbreaking technology to market and make a significant impact on the lives of millions of people worldwide.

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