Pixium Vision (EPA:PIX) said today it won approval from France’s regulatory agency to launch a feasibility clinical study of its next-gen Prima sub-retinal implant in patients with advanced dry age-related macular degeneration.
The Prima system is a next-gen wireless implant with a micro photovoltaic chip designed to be implanted under the retina to convert pulsed near-infra-red invisible light received from external glasses with an integrated mini-camera into electrical signals transmitted to the brain through the optic nerve, the company said.
The system is designed to treat retinal dystrophies with a focus on advanced atrophic dry-AMD, though the company has plans to evaluate the system at a later date for treating patients with retinitis pigmentosa.
“The approval of the clinical study is a significant advance for the Prima system, our next generation wireless sub-retinal implant system, as well as for Pixium Vision. Conceived initially by the researchers at Stanford University, and successfully developed through to clinical stage by our team at Pixium Vision in close collaboration with numerous physicians and scientists, Prima enters an exciting phase of its development, with a first patient expected to be implanted before year end. With aging population dynamics, advanced dry-AMD is a leading cause of irreversible vision loss1 with currently estimated over 4 million people without approved treatment option making it a significant unmet medical need,” CEO Khalid Ishaque said in a prepared statement.
The clinical study is slated to recruit 5 patients with evaluations at 6 months and 36 months, exploring tolerance of the Prima system and evaluating evoked central visual perception amongst patients who’ve lost their sight due to dry age related macular degeneration, the France-based company said.
The study will be conducted at Paris’ Fondation Ophtalmologique Rothschildand Hôpital des Quinze-Vingt by principal investigator Dr. Yannick Le Mer.
Pixium Vision said it is engaged in conversations with the FDA as it seeks to launch a feasibility study of the Prima in the US.
In February, Pixium Vision said its Iris II ‘bionic eye’ won NUB 1 reimbursement status from the German Institute for the Hospital Remuneration System.