• 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

Ocular Therapeutix OTX-TP trial misses primary endpoint

May 22, 2019 By Danielle Kirsh

Ocular Therapeutix logo

A Phase 3 clinical trial of the ORX-TP eye insert made by Ocular Therapeutix (NSDQ:OCUL) failed to meet the primary endpoint of significant superiority in the reduction of intraocular pressure.

OTX-TP is an intracanalicular insert that delivers a preservative-free formulation of travoprost to reduce intraocular pressure.

The randomized, double-blind, placebo-controlled clinical trial took place across more than 50 sites with 554 subjects who had open-angle glaucoma or ocular hypertension in the full analysis set population. The primary efficacy endpoint was a statistically superior mean reduction of IOP compared with a placebo insert at nine times and three diurnal time points at two, six and 12 weeks.

The trial did not achieve the primary endpoint of statistically significant superiority in the reduction of IOP compared with placebo at all nine point times. The differences were statistically significant for eight of the nine time points, according to the company. Reductions from baseline ranged from 3.27 to 5.72 mm of mercury across all nine time points with higher intraocular pressure reduction at earlier time points in the trial.

Ocular Therapeutix said that the OTX-TP was generally well tolerated with no serious adverse events reported. The most common adverse effect was dacryocanaliculitis (7% in OTX-TP and 3% in placebo) and lacrimal structure disorder (6% in OTX-TP and 4% in placebo).

“We are encouraged by the results of this trial which shows OTX-TP’s ability to lower IOP out to 12 weeks with a single insert using this novel dosage form,” Dr. Michael Goldstein, chief medical officer, said in a press release. “In our opinion, this product candidate represents a new opportunity for treating glaucoma patients that has the potential to address one of the biggest issues we deal with in clinical practice, the challenges patients have in taking eye drops. We will continue to review the data from the trial, and we look forward to meeting with the FDA to discuss these results before determining the next steps in our clinical development plans.”

Filed Under: Clinical Trials, Featured, Optical/Ophthalmic Tagged With: Ocular Therapeutix

IN CASE YOU MISSED IT

  • Tandem Diabetes Care delivers 1 million insulin boluses using t:connect mobile app
  • Nuvo, Sheba Medical Center develop AI-powered gestational diabetes management platform
  • Verily’s Onduo, Sword Health collaborate on virtual diabetes care
  • Shareholder lawsuit over BD’s Alaris pumps recall moves forward
  • Embecta stock soars on first full-quarter results after BD spinoff

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.

Signup for the newsletter

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing & Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2022 · 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