Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

Shire Receives Long-Awaited Approval For Dry Eye Drug

XTALKS VITALS NEWS

Eye

While patients with dry eye disease already have multiple treatment options – including Allergan’s Restasis (cyclosporine) – Shire says that its drug is the only treatment that addresses both the signs and symptoms of the condition.

Tweetables from this article:

Tweet: Shire’s dry eye disease drug lifitegrast has finally received #FDA approval http://ctt.ec/H1Bx3+Shire’s dry eye disease drug lifitegrast has finally received FDA approval.

Tweet: Shire's dry eye drug could reach annual sales of $1 billion per year http://ctt.ec/fhpbB+Shire's dry eye drug could reach annual sales of $1 billion per year.

Share this!

July 13, 2016 | by Sarah Massey, M.Sc.

Almost one year after being rejected by the US Food and Drug Administration (FDA), Shire’s dry eye disease drug, lifitegrast, has finally received regulatory approval. The biopharmaceutical company is now looking ahead to the drug’s blockbuster sales potential.

In October of 2015, the FDA issued a complete response letter to Shire, requiring the company to perform more clinical trials before the drug could be considered for approval. At the time, Shire was already conducting a Phase III clinical trial which concluded just before the end of the year.

The company used this data to file a quick resubmission for lifitegrast to the FDA. Now that the drug has gained regulatory approval for the indication of treating the signs and symptoms associated with dry eye disease, Shire will market lifitegrast under the name Xiidra.

Analysts have already begun to estimate the drug’s annual sales at a potential $1 billion per year at its peak. This potential blockbuster drug will be launched in the third quarter of this year.

“The approval of Xiidra marks a new day in treatment options for patients with dry eye disease, with the only prescription eye drop approved in the U.S. specifically to treat both the signs and symptoms of the condition,” said Flemming Ornskov, CEO of Shire. “As Shire’s first FDA-approved medicine in ophthalmics, this significant milestone advances our goal of becoming the global leader in this category, where there are unmet patient needs. We have a robust ophthalmics pipeline, and we look forward to leveraging Xiidra as our entrée into the space as we continue to develop additional innovative eye care treatment options.”



Common symptoms of dry eye disease including eye dryness, stinging, burning, blurred vision and general eye discomfort. According to Shire, approximately 16 million people in the US are affected by the eye condition.

While patients with dry eye disease already have multiple treatment options – including Allergan’s Restasis (cyclosporine) – Shire says that its drug is the only treatment that addresses both the signs and symptoms of the condition. Despite their late entry onto the market, Shire hopes the drug will be a best-seller.

Auven Therapeutics is also looking to enter the dry eye disease space with its reformulated version of Allergan’s Restasis. While the drug is still in clinical trials, Auven has high hopes for the treatment as Allergan’s version brings in about $1.3 billion in sales every year.

Auven anticipates that it will be filing for FDA approval sometime in 2017, as a Phase III clinical trial of the drug is still underway. Shire’s dry eye drug approval is a big win for the company’s Ophthalmics Business Unit (OBU), which was established two years ago.


Keywords: FDA, Blockbuster, Eye Disease


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
IBS Patients Taking Viberzi May Be at Increased Risk of Pancreatitis

March 22, 2017 - According to a recent drug safety communication issued by the US Food and Drug Administration (FDA), patients with irritable bowel syndrome (IBS) with diarrhea should not be treated using Viberzi (eluxadoline), if they do not have a gallbladder.

Featured In: Drug Safety News


PTC to Acquire Marathon’s Recently Approved Duchenne Muscular Dystrophy Drug

March 17, 2017 - Amid a drug pricing controversy, PTC Therapeutics has agreed to buy Marathon Pharmaceuticals’ Duchenne muscular dystrophy (DMD) drug, Emflaza.

Featured In: Pharmaceutical News


Memphis Meats Produces World’s First Poultry from Animal Cells

March 17, 2017 - Silicon Valley-based food manufacturing company, Memphis Meats, has produced the world’s first “clean poultry” by growing chicken and duck cells outside the animals.

Featured In: Food News

LEAVE A COMMENT
 
  
THE XTALKS VITALS LIFE SCIENCE BLOG

Will Pharmaceutical Serialization Solve All of Our Drug Counterfeiting Problems?

REGISTER FOR THESE WEBINARS

How to Improve the Speed and Efficiency of Your Clinical Trials


High Performance Computing for High Content Screening - A Case Study


The FDA Guidance on the Assessment of Abuse Potential of Drug – A Critical Review


Treatment of Psoriasis: Improvements Through Clinical Trials


Copyright © 2016-2017 Honeycomb Worldwide Inc.