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

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Ocugen kicks off dry eye disease trial for nanoemulsion eye drop

October 1, 2018 By Sarah Faulkner

Ocugen logo - updatedOcugen said today that it launched a Phase III trial designed to evaluate its twice-daily 0.2% brimonidine tartrate eye drop in patients with dry eye disease.

Ocugen plans to run two identical Phase III trials of OCU310, enrolling 240 participants per study. The company said it will assess safety and efficacy results after just 28 days of treatment, due to the early potential therapeutic benefits of brimonidine tartrate that Ocugen observed in the Phase II study.

The Phase III trials’ primary endpoints are the change from baseline to four weeks in symptom assessment in dry eye (SANDE) score and the change in lissamine green conjunctival staining scores.

The company said it expects topline data in the second half of 2019.

“We believe OCU310 could be an important treatment option for the management of DED, based on brimonidine’s multiple modes of action, our OcuNanoE formulation technology, and the favorable results of our recent Phase II study,” CMO Dr. Daniel Jorgensen said in prepared remarks.

“We are pleased to advance our second lead product candidate into Phase III clinical development,” chairman, CEO & co-founder Shankar Musunuri added. “OCU310 has the potential to improve the signs and symptoms in patients with DED as early as 28 days as opposed to existing therapies.”

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Optical/Ophthalmic, Pharmaceuticals Tagged With: ocugen

IN CASE YOU MISSED IT

  • Surmodics’ DCB shown non-inferior to Medtronic’s In.Pact Admiral
  • How continuous glucose monitors have transformed the diabetes landscape
  • Biden’s COVID-19 response will make manufacturers busy
  • Mylan must face EpiPen racketeering lawsuit
  • EmblemHealth to provide coverage for Senseonics’ Eversense CGM

Primary Sidebar

MEDTECH 100 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.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Tweets by DrugDeliveryNow

Footer

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Design & Outsourcing
Medical Tubing + Extrusion

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery News
Advertise with us
About
Contact us
Privacy
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2021 · 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.

Advertise | Privacy Policy | RSS