Pixium Vision Discovered Novel Prima System for Dry Age-Related Macular Degeneration

Pixium Vision discovered novel Prima System for the treatment of dry age-related macular degeneration (AMD).

Prima System seems to hold great promise for the treatment of dry age-related macular degeneration (AMD). By utilising a photovoltaic substitute for photoreceptors, the Prima System aims to restore vision partially in patients with atrophic dry AMD.

The PRIMAvera study, based on positive results from a French feasibility study, is designed to evaluate the efficacy and safety of the Prima System.

The primary efficacy endpoint of the study is the proportion of subjects who experience an improvement in visual acuity of logMAR 0.2 or more from baseline after 12 months. The primary safety endpoint focuses on monitoring the number and severity of device and procedure-related serious adverse events at the 12-month follow-up.

The Prima System in the clinical setting is indeed encouraging, and it brings hope for individuals with dry AMD who may benefit from this innovative treatment approach.

U.S. Food and Drug Administration (FDA) grants Breakthrough Device Designation to the Prima System.