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

Drug Delivery Business

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

pSivida takes another stab at FDA approval for Iluvien

March 27, 2013 By drugdelivery

pSivida

Alimera Sciences

It’s been a rocky road for pSivida‘s (NSDQ:PSDV) Illuvien, a drug/device combination for diabetic macular edema, but the company hopes that new trial data will pave the way to regulatory approval in the U.S.

Watertown, Mass.-based pSivida, which licenses the Iluvien technology to Alimera Sciences (NSDQ:ALIM), said the 2 companies plan to re-submit a new drug application to the FDA by the end of this month.

pSivida and Alimera will use data from 2 completed Phase III trials from the FAME study, which failed to prove safety in previous approval submissions. The federal watchdog agency originally rejected Iluvien back in November 2011 because FAME did not prove that the treatment’s benefits outweigh its potential harm, sending shares sliding on Wall Street.

To glean positive results from the new FAME trials,pSivida focused on safety for patients with chronic diabetic macular edema who do not respond to conventional therapy – the same patient group that European regulators used to green-light the therapy there, according to a press release. pSivida said it’s waiting to hear from Germany’s Medicine & Health products agency to begin commercializing Iluvien.

pSivida suffered a blow in November, when the U.K.’s National Institute for Health and Clinical Excellence struck down Illuvien because of its expense. Alimera reported that a compromise patient access scheme is now under review by the U.K.’s regulatory agency and that it expects to begin shipments to the U.K. during the 2nd quarter for privately insured patients.

Filed Under: Drug-Device Combinations Tagged With: Alimera Sciences, New Drug Application (NDA), pSivida Corp.

IN CASE YOU MISSED IT

  • Medtronic enrolls first patient in study for Onyx liquid embolic system
  • BD issues voluntary recall on certain Alaris infusion pump modules
  • Sequel Med Tech expects full twiist launch in the fall
  • Insulet hires new chief HR officer from J&J
  • Breakthrough T1D, Mattel debut Barbie doll with type 1 diabetes

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

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.

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

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 | RSS