Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

EMA

Oxervate gets EMA approval for rare degenerative eye disease

The European Medicines Agency (EMA), which evaluates medicinal products for use in Europe, has recommended Oxervate (marketed by Dompé) for marketing authorisation for the treatment of moderate or severe neurotrophic keratitis.

The eye disease results from damage to the trigeminal nerve and subsequent progressive degeneration of the cornea. In severe cases it can lead to blindness.

There are currently no specific pharmacological treatments for the eye disease, which is often managed with artificial tears and antibiotics, as well as surgery, in some cases.

Oxervate, whose active ingredient is cenegermin, is a recombinant form of human nerve growth factor, delivered via eye drops, and is intended to recover an adequate nerve response to preserve and heal the cornea.

The EMA recommendation was based on data from two phase II clinical trials involving 204 patients with moderate and severe disease. In both studies, more Oxervate-treated patients achieved complete corneal healing after eight weeks compared with placebo-treated patients.

The most common adverse reactions included eye and eyelid pain, eye inflammation, increased tear production and a foreign-body sensation in the eye.

Oxervate was reviewed under the EMA’s accelerated assessment programme, intended to increase access to treatments that address unmet medical needs, after receiving orphan designation in 2015. Neurotrophic keratitis is thought to affect between 1 and 5 people out of every 10,000.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202842

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Disease Management

    Disease Management

    Disease Management covers the diseases commonly encountered in primary care by system, with common therapeutic issues. Includes case studies and self-assessment sections.

    £52.00Buy now
  • Minor Illness or Major Disease

    Minor Illness or Major Disease

    This established textbook helps you differentiate between minor illnesses which can be safely managed in the pharmacy, and major diseases.

    £42.00Buy now
  • Biological Therapeutics

    Biological Therapeutics

    An introduction to the treatment of disease using biological medicines derived from living plant and animal tissues.

    £32.00Buy now
  • Sampson's Textbook of Radiopharmacy

    Sampson's Textbook of Radiopharmacy

    This well-established textbook provides specialised information on the use of radiopharmaceuticals in the detection and treatment of diseases.

    £79.00Buy now
  • Zoonoses

    Zoonoses

    An accessible textbook covering zoonotic diseases, which affect humans but are contracted from animals.

    £47.00Buy now
  • Drugs and the Liver

    Drugs and the Liver

    Drugs and the Liver assists practitioners in making pragmatic choices for their patients. It enables you to assess liver function and covers the principles of drug use in liver disease.

    £37.00Buy now

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Site powered by Webvision