Accessibility Statement Skip Navigation
  • Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All Public Company News
      • All Multimedia News
      • View All News Releases

      • Regulatory News

      • D/A/CH Regulatory News
      • UK Regulatory News
      • View All Regulatory News

  • Business & Money
      • Auto & Transportation

      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalisation
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls & Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defence
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers & Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines & Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics & Personal Care
      • Fashion
      • Food & Beverages
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewellery
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Overview
  • Distribution
  • Paid Placement
  • Multimedia
  • Disclosure Services
  • SocialBoost
  • Rooms
    • MediaRoom
    • ESG Rooms
  • AI Tools
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Hamburger menu
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO
    • Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • News in Focus
    • Browse News Releases
    • Regulatory News
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
    • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • Overview
  • Distribution
  • Paid Placement
  • Multimedia
  • Disclosure Services
  • Cision Communications Cloud®
  • AI Tools
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists

NICE Recommends OZURDEX(R), an Innovative Treatment for Retinal Vein Occulsion (RVO), a Common Cause of Vision Loss


News provided by

Allergan

05 Jun, 2011, 23:01 GMT

Share this article

Share toX

Share this article

Share toX

MARLOW, England, June 6, 2011 /PRNewswire/ --

Allergan announces today that the National Institute for Health and Clinical Excellence (NICE) has recommended OZURDEX(R) (dexamethasone 0.7mg intravitreal implant in applicator) for the treatment of macular oedema due to central retinal vein occlusion (CRVO) and also for branch retinal vein occlusion (BRVO) where laser photocoagulation is neither beneficial nor appropriate.

RVO is an eye condition that can lead to severe damage to the retina, visual impairment and even blindness. The visual impairment that often results from RVO can significantly impact on patients' quality of life and ability to do everyday things, such as reading a newspaper, watching a film or driving.[1] Up to 25,000 patients in the UK every year suffer from macular oedema associated with RVO and may be suitable for treatment with OZURDEX.[2]

OZURDEX is an innovative, first-of-its-kind biodegradable intravitreal implant containing dexamethasone, a highly potent corticosteroid, administered via a specially designed, single use applicator.[3,4] Dexamethasone is slowly released from the implant into the eye and acts locally to control oedema, reduce inflammation around the occlusion and improve vision. A single injection can offer long lasting improvement with benefits demonstrated to last for up to six months.

Mr. Ian Pearce, Consultant Ophthalmologist and the Clinical Expert representative of the Royal College of Ophthalmologists said: "The availability of a licensed, effective and now NICE recommended treatment is a significant step forward for management of RVO patients in England and Wales and we look forward to ophthalmologists providing the treatment ASAP."

"RVO is the second most common cause of reduced vision due to retinal vascular disease. The decision announced today represents the first NICE recommendation for a licensed treatment for macular oedema associated with RVO and with it NICE has made available to retinal specialists and their patients an important treatment for this potentially devastating condition," said Mr. Douglas D. Ingram, Executive Vice President, President, Allergan, Europe, Africa and the Middle East. "We look forward to working with retinal specialists, hospitals and commissioning groups in the UK to support the National Health Service in rapidly adopting this cost effective solution to maximise patient benefits and to minimise premature vision loss as a result of RVO."

"We are really pleased with this decision from NICE to recommend that suitable patients with RVO are treated with OZURDEX on the National Health Service. As with many other eye conditions, it is really important that RVO is treated as early as possible. Anyone noticing any change in their vision should have their eyes checked as soon as possible," said Barbara McLaughlan, Policy and Campaigns Manger for the Royal National Institute of Blind People (RNIB).

OZURDEX clinical data

The efficacy of OZURDEX was assessed in two 6-month, prospective, double-masked, parallel-group studies in which 1267 patients with macular oedema due to either branch or central retinal vein occlusion (BRVO or CRVO) were randomised to receive either OZURDEX or a sham (placebo) procedure. Clinically significant improvement in vision (defined as [greater than or equal to]15 letters or 3 lines on an eye chart) was seen after 2 months in up to 30% of patients with macular oedema due to RVO following just one injection of OZURDEX. In some patients this improvement was maintained for up to 6 months.[5] Importantly, up to 80% of patients had an improvement or no worsening in vision over the 6 months (defined as >0 letters on an eye chart).[6] The most frequently reported adverse reactions in patients who received OZURDEX(R) were increased intraocular pressure (24.0%) and conjunctival haemorrhage (14.7%).[7]

Notes to Editor

About Retinal Vein Occlusion

RVO is an important and common cause of vision loss,[8] affecting 5 in every 1,000 people over the age of 30.[9] It is estimated that more than 200,000 people suffer from RVO in the UK.[9,10]

RVO occurs when a retinal vein in the eye becomes blocked (occluded). [5] This blockage in the retinal vein leads to an inflammatory response, resulting in a build up of fluid in the retina and thickening of the macula (called macular oedema).[11] Macular oedema is a leading cause of vision loss in patients with RVO.[12,13] OZURDEX is the only approved medicine for the treatment of macular oedema in RVO. Other interventions include surgery and laser photocoagulation therapy, although these are not universally effective.[14,15] RVO can cause significant direct healthcare costs, as well as indirect costs to patients and society, such as loss of income and costs to adapt a person's home.[16,17]

About Macular Oedema Caused by Retinal Vein Occlusion (RVO)

Macular oedema is a common consequence of a number of retinal diseases, with inflammation playing a significant role.[3,8,18] Macular oedema is an excessive build up of fluid in the retina and thickening of the macula.[11] Macular oedema can lead to vision impairment if left untreated and it is the primary cause of vision loss in patients with branch RVO (occlusion in a branch retinal vein),[12] and is one of the leading causes of visual loss in patients with central RVO (occlusion in a central retinal vein).[13] Macular oedema is a common complication of diabetic retinopathy and is the leading cause of vision loss in patients with diabetes.[9] Uveitis can lead to macular oedema through an inflammatory process[19] and macular oedema is one of the main reasons for visual loss in uveitis.[20]

References

---------------------------------

[1] Deramo VA, Cox TA, Syed AB, et al. Vision-related quality of life in people with central retinal vein occlusion using the 25-item National Eye Institute Function Questionnaire. Arch Opthalmol 2003;121:1297-302.

[2] Data on File, Allergan, Inc.

[3] Kuppermann BD, Blumenkranz MS, Haller JA, et al. Randomized controlled study of an intravitreous dexamethasone drug delivery system in patients with persistent macular edema. Arch Ophthalmol 2007;125:309-17.

[4] Haller JA, Dugel P, Weinberg DV, et al. Evaluation of the safety and performance of an applicator for a novel intravitreal dexamethasone drug delivery system for the treatment of macular edema. Retina 2009;29:46-51.

[5] Haller JA, Bandello F, Belfort R et al. .Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology 2010,117:1134-46.

[6] Data on File 4B-65, Allergan, Inc.

[7] OZURDEX(R) Summary of Product Characteristics, July 2010.

[8] Royal College of Ophthalmologists. Retinal Vein Occlusion (RVO) Interim Guidelines. February 2009.

[9] Rogers S, McIntosh RL, Cheung N, et al. The prevalence of retinal vein occlusion: pooled data from population studies from the United States, Europe, Asia and Australia. Ophthalmology. 2010;121:1297-302.

[10] United Nations. World population prospects: the 2008 revision. Population database. Accessed 11 January 2010.

[11] Johnson MW. Etiology and treatment of macular edema. Am J Ophthalmol 2009;147:11-21.

[12] Margolis R, Singh RP, Kaiser PK. Branch retinal vein occlusion - clinical findings, natural history, and management. Compr Ophthalmol Update 2006;7:265-76.

[13] Weinberg , DV, Seddon JM. Venous occlusive diseases of the retina. In: DM Albert, FA Jakobiec. Principles and Practice of Ophthalmology. Philadelphia: WB Saunders Company,1994;2:735-46.

[14] The Branch Vein Occlusion Study Group. Argon laser photocoagulation for macular edema in branch vein occlusion. Am J Ophthalmol 1984;98:271-82.

[15] The Central Vein Occlusion Study Group M report. Evaluation of grid pattern photocoagulation for macular edema in central vein occlusion. Ophthalmology 1995;102:1425-33.

[16] Future Sight Loss UK (1): The economic impact of partial sight and blindness in the UK adult population. Executive summary. RNIB June 2009

[17] Lafuma A, Brezin A, Lopatriello S, et al. Evaluation of non-medical costs associated with visual impairment in four European countries. France, Italy, Germany and the UK. Pharmacoeconomics 2006;24:193-205.

[18] Tranos PG, Wickremasinghe SS, Stangos NT et al. Macular edema. Surv Opthalmol 2004;49;470-90.

[19] Forrester JV. Uveitis:pathogenesis. Lancet 1991;338:1498-501.

[20] Durrani OM, Tehrani NM, Marr JE et al. Degree, duration, and causes of visual loss in uveitis. Br J Opthalmol 2004;88:1159-62.

Modal title

Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT
  • General Enquiries
  • Media Enquiries
  • Partnerships

Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United States
  • Vietnam

My Services

  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
  • Data Privacy

Do not sell or share my personal information:

  • Submit via Privacy@cision.com 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 PR Newswire Europe Limited. All Rights Reserved. A Cision company.