Ophthalmology Drug Futures

Published Date: 12/04/2011
Category: Therapies & Markets

Research Report Decription

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THREE ELADING OCULAR CONDITIONS AGE-RELATED MACULAR DEGENERATION,  GLAUCOMA & DRY EYE SYNDROME HAVE BEEN A MAJOR FOCUSE FOR PHARMACEUTICAL R&D. The market for drugs used to treat wet age-related macular degeneration (AMD) is estimated to be worth US$3.3 billion. There are relatively few players and an increasing patient pool; continued growth is expected over the medium term. The current standard of care for wet AMD is Lucentis (ranibizumab), marketed by Roche in the US and Novartis elsewhere. Growth has been impressive since its launch in 2006; global sales amounted to US$3 billion in 2010. The cost of treatment is high, however, and there is some competition from off-label use of Roche’s Avastin (bevacizumab), which is significantly cheaper. In the US, the National Eye Institute is conducting a major Phase III comparative study of Avastin and Lucentis for the treatment of AMD. But there is new competition expected on the market. Glaucoma affects around 65-70 million people worldwide and is the second leading cause of blindness, after cataracts. The WHO estimates that glaucoma was responsible for around 12.3% of world blindness in 2002, affecting around five million people.  Undoubtedly, generic companies will claim a significant share of the US$4.9 billion glaucoma market over the next few years. Pfizer’s US patent for the market leader, Xalatan (latanoprost) expired in March 2011 and the first generics have been approved. Alongside glaucoma and AMD, dry eye is a growing problem and one that also increases with age. While this condition is widely treated with artificial tear products that are available over the counter, the prescription market is currently worth around US$1.5 billion.

Key Questions Answered:

The US$14 billion global ophthalmology sector faces both commercial challenge and clinical opportunity, and this report answers key questions:

• Why are we interested in chronic eye diseases?
• Driven by ageing populations, which markets are expected to see the highest growth in the 65+ age groups?
• Which sectors of the market are anticipated to contract by value over the next five years?
• What new products will be launched over the next 5 years and what impact will they have on the market?
• Which companies are set to improve their market share?
• What novel products are in development for Wet Age-related Macular Degeneration (AMD)?
• Dry AMD – large unmet clinical need, but what is the potential?
• What potential benefits does Bayer’s VEGF Trap‐Eye Regeneron have over existing treatments?
• Merck’s NDA for Saflutan was submitted to FDA in March 2011 – what impact on the market could this product have?Why are new treatments needed for dry eye?

Paper Highlights:

• The most advanced developmental treatment for AMD is Bayer and Regeneron’s VEGF Trap-Eye. Following positive top-line results from Phase III trials, regulatory filings have been planned in the US and EU in 2011. If approved, it is expected that this product will be quickly taken up in the market-place. It appears to have similar efficacy to Lucentis with less frequent dosing, which is likely to prove popular among patients and healthcare providers alike.
• Drugs to treat glaucoma are also set to lose exclusivity over the next few years. Dependent on the outcome of patent litigation, Alcon’s Travatan Z (travoprost) could face generic competition in the US as early as December 2011. Allergan’s US patents for Lumigan (bimatoprost) will expire in 2012 and 2014, while the European patents are set to expire in various markets between 2013 and 2017. In the short term, there may be new competition in the US if Merck & Co is successful in gaining approval for Saflutan (tafluprost). Merck & Co has a licensing agreement for the product with Santen Pharmaceutical who market it in some Asian/European markets. 
• Beyond new formulations and combination products in Phase III, the most advanced novel agents have yet to progress beyond Phase II.There are relatively few prescription pharmaceuticals to treat more severe cases; in the US, Allergan’s Restasis (ciclosporin) ophthalmic emulsion is currently the only product approved to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation. Competition may be on the horizon, however, from ISTA Pharmaceuticals’ Remura (bromfenac), which is in Phase III for the condition.