Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Issues "Complete Response" On Alimera's Iluvien; Eyes More Data

This article was originally published in The Pink Sheet Daily

Executive Summary

The ophthalmology company received a “complete response” for lead product Iluvien.

You may also be interested in...



Alimera Resubmits Iluvien In U.S. As It Begins EU Launch

The Atlanta-based ophthalmology company hopes to succeed in third try with FDA, but must split its focus with Europe as it tries to roll out launches in several countries at once.

Alimera To Resubmit Iluvien With No New Studies

FDA has twice rebuffed Alimera’s marketing application for the intravitreal insert, which releases a corticosteroid to treat chronic diabetic macular edema, citing a bad risk/benefit balance. But after meeting with the agency in the second quarter, the company is confident a reanalysis of pivotal data will satisfy the agency.

Alimera’s Iluvien Suffers Same Demise As Lucentis; NICE Rejects For DME

Triumphant in Europe at the regulatory stage, Alimera finds that health technology assessment is a different ball game, as NICE turns down Iluvien for diabetic macular edema on two counts.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS071661

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel