Pixium Vision Gets Green Light for US Study of PRIMA Retinal Implant in Atrophic Dry AMD

January 5, 2018: By Jon Swedien

Pixium VisionPixium Vision has received approval from the US FDA to begin a clinical feasibility study for PRIMA, a miniaturized wireless photovoltaic subretinal implant, in patients with atrophic dry age-related macular degeneration (AMD), the company announced Jan. 4.

The clinical feasibility study for the PRIMA implant will be conducted at the University of Pittsburgh Medical Center, Pixium said. It will recruit up to five patients with vision loss resulting from atrophic dry AMD. The primary endpoint is restoration of visual perception and safety at a 12-month follow-up, with a longer-term follow-up at 36 months, Pixium said.

The Paris-based company said it expects to start the US study in the first half of 2018.

Need Deeper Analysis? Sign up for Market Scope's monthly newsletter to get in-depth coverage of the ophthalmic market, including quarterly procedure volumes based on survey data and meeting coverage from around the world.

Recent Ophthalmic News

US Health Secretary Alex Azar Takes Aim at Rebates in US Senate Hearing

Beyeonics Surgical Raises $11.5 Million in Initial Funding Round

MeiraGTx Raises $75 Million in Initial Public Offering

GenSight to Pursue Approval for LHON Gene Therapy Candidate, Despite Phase III Setback

Optovue Receives FDA Clearance for AngioAnalytics, First OCT Angiography Metrics

Nexy Robotic Retinal Imaging System Receives FDA Clearance

Ocutrx Receives US Patent for Oculenz AR Glasses for Macular Degeneration

Allergan’s Bimatoprost SR Demonstrates Noninferiority to Timolol in Phase III Glaucoma Study

KKR to acquire Envision Healthcare, Including Amsurg ASC Business

Ophthalmologist Carmen Puliafito, MD, Seeks to Regain Medical License

Avedro Gains J Code for Photrexa Formulations in Preliminary CMS Decision

EyeGate Seeks to Study Ocular Bandage Gel in Punctate Epitheliopathy

Nicox, Ironwood to Collaborate on Novel Ophthalmic Treatments

US FDA Approves MDGH’s Moxidectin for Treatment of River Blindness

Bausch + Lomb Enrolls First Patient in Trial for enVista MX60EF Trifocal IOL

Cincinnati Eye Institute Partners with Private Equity Firm to Pursue National Expansion

Ophthotech Enters Gene Therapy Deals with University of Florida, University of Pennsylvania

Teva’s Launches Generic Version of Restasis in Canada

Clearside’s Phase II Trial for DME Candidate Meets Primary Endpoint

Orasis Raises $13 Million in Series B Financing

Coming soon

2018 Optical Coherence Tomography Report: A Global Market Analysis for 2017 to 2023