• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Presbia touts 6-month data for Flexivue microlens

Presbia touts 6-month data for Flexivue microlens

May 18, 2016 By Fink Densford

Presbia pivotal Microlens trial nears endPresbia (NSDQ:LENS) today reported interim data from a U.S. pivotal trial of its Flexivue microlens, touting an average gain of 5 lines of uncorrected near visual acuity and 99% maintenance of binocular uncorrected distance vision.

The company reports a total of 421 subjects have been implanted with the Flexivue microlens in the trial, which is being carried out as the company seeks FDA premarket approval. Presbia said it is planning for a final PMA module submission in September 2017.

An average gain of 5 lines of uncorrected near visual acuity in treated eyes, as well as a 99% rate of maintained binocular uncorrected distance vision, according to an SEC filing.

Presbia said it is currently focusing on commercialization efforts in South Korea, with a Korean Presbia certified surgeon slated to present 1-year patient results in mid-June this year.

Last August, Presbia said it is nearing completion of enrollment in a pivotal trial of its Flexivue Microlens implant. The Dublin-based company said it had enrolled 300 patients at the time and submission of its final PMA module would come after the 24-month follow-up of the subjects.

Last February, Presbia received FDA clearance to enroll patients in the 2nd stage of a pivotal study for its Flexivue Microlens for treating presbyopia.

A month earlier Presbia raised less than the $50 million midpoint it set for its initial public offering, pricing its 4.2 million-share IPO at $10 rather than $11 to $13. Total proceeds were $42 million. LENS shares closed at $6.67 apiece yesterday, up 0.6%.

The Presbia lens won CE Mark approval in the European Union in December 2009.

Filed Under: Clinical Trials, Optical/Ophthalmic Tagged With: Presbia

More recent news

  • Medtronic reports first patient treated in study of multi-organ denervation for hypertension
  • Baxter turns to an automation company for its new CEO
  • Pristine Surgical appoints new CFO
  • Boston Scientific wins expanded FDA nod for Farapulse PFA
  • FDA warns on issue with J&J Abiomed pump controllers related to 3 deaths

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy