Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Novozymes Biopharma’s Recombinant Human Albumin Helps Dry Eye Therapy Move into Clinical Trials

Published: Wednesday, May 22, 2013
Last Updated: Wednesday, May 22, 2013
Bookmark and Share
A novel ophthalmic solution from R-Tech Ueno (Tokyo, Japan) made using Novozymes Biopharma’s recombinant human albumin has recently obtained FDA approval to undergo Phase I/II clinical trials in the United States.

Novozymes Biopharma has announced that an ophthalmic solution made using its recombinant human albumin, has been approved for Phase I/II development by the FDA.

Designed by R-Tech Ueno, RU-101 ophthalmic solution is being trialled as a therapy for severe dry eye, for which no effective treatment is currently available.

The recombinant human albumin is part of Novozymes Biopharma’s albumin range. Novozymes Biopharma has a strong reputation in the industry for helping customers in the safe and successful commercialization and approval of new products.

The prevalence of severe dry eye, where patients suffer from instability of the tear film, continues to increase. It is the most diagnosed of all ophthalmic disorders and estimates put the market at approximately 1.5 billion USD.

The trials for RU-101 ophthalmic solution will move ahead in two stages, the first of which will assess safety using a placebo control, and allow confirmation of the maximum dose.

The second stage will then use this maximum dose for 12 weeks to evaluate the safety and effectiveness of RU-101 ophthalmic solution.

Dermot Pearson, Marketing Director at Novozymes Biopharma said, “Novozymes is dedicated to supporting our customers in the drug development and testing stages, and in assisting with the optimization of their pathways through regulatory approval procedures. We are therefore delighted that RU-101 ophthalmic solution has been approved for clinical testing.”

Novozymes Biopharma’s recombinant albumin is designed to provide quality performance benefits when included in drugs developed by our customers.

It was selected as a key component of this novel therapy back in 2011, due to its proven high quality and enhanced safety profile.

Animal-free, with an exceptional purity profile and convenient liquid format at room temperature, recombinant albumin delivers consistent levels of quality, leading to reduced lot testing and vendor auditing.

All Novozymes’ recombinant human albumins deliver stable, safe and regulatory compliant ingredients for drug delivery and formulation, and are compliant with the National Formulary (NF) rAlbumin human monograph published by the United States Pharmacopeia (USP).


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,000+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Novozymes Starts Commercial Supply of New and Improved Hyaluronic Acid from Q7 cGMP Facility
Hyasis sets a new standard for hyaluronic acid offering unprecedented safety, consistency and performance.
Friday, May 11, 2012
Scientific News
Advanced Lymphoma in Remission After T-Cell Therapy
63% of trial participants who recieved two-drug combination chemo plus intermediate dose of engineered T cells went into complete remission.
New Treatment for Immune Cancers
Clinical trial shows new drug holds promise for treating advanced mastocytosis.
Sickle Cell Gene Therapy Passes Test
Researchers found a precision-engineered gene therapy virus reduced sickle-induced red-cell damage in mice with sickle cell disease.
Opening Door to Oesophageal Cancer Targeted Treatments
Scientists have discovered that oesophageal cancer can be classified into three different subtypes.
Inovio Launches Zika Vaccine Trial
Inovio launches Zika vaccine trial in midst of Puerto Rico epidemic to explore early signals of vaccine efficacy.
Vitamin C May Boost Leukemia Treatment
Studies show that supplementing an epigenetic cancer drug with vitamin C enhanced the drug's effectiveness.
New Hope for Zika Treatment Found in Large-Scale Screen of Existing Drugs
Johns Hopkins researchers join collaborative group to screen 6,000 existing drugs in hopes of finding treatments for Zika Virus infection
FINCH Filgotinib Phase 3 Program Initiated
Galapagos NV reports the initiation of the FINCH global Phase 3 program in rheumatoid arthritis patient populations.
Stem Cell Therapy Heals Injured Mouse Brain
A team of researchers has developed a therapeutic technique that dramatically increases the production of nerve cells in mice with stroke-induced brain damage.
Zika Vaccine Testing in Humans
The NAAID has initiated a clinical trail of a vaccine candidate for the prevention of the Zika virus infection.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!