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How is the Age-Related Macular Degeneration Space Faring Now?

The Age-Related Macular Degeneration (AMD) space has been in the spotlight of late due to a number of developments. Earlier in the month, Swiss pharma company Roche Holdings AG RHHBY suffered a setback when its ophthalmology candidate, lampalizumab, failed to achieve the primary endpoint in late-stage studies. The candidate was being evaluated for the treatment of geographic atrophy (GA), an advanced form of AMD.  Lampalizumab did not reduce mean change in GA lesion area compared to sham treatment for 1 year (48 weeks).

Last month, Ophthotech Corporation OPHT also announced disappointing results from a phase III study, OPH1004. The study evaluated its pipeline candidate Fovista (an anti-PDGF therapy) in combination with Regeneron Pharmaceuticals, Inc.’s REGN Eylea (aflibercept) or Roche’s Avastin (bevacizumab) for the treatment of wet AMD.

AMD and its Types

AMD is a disorder of the central portion of the retina, known as the macula, which might lead to blindness. There are two forms of AMD — dry AMD and wet AMD. Dry AMD can lead to wet AMD. GA is a progressive and irreversible form of AMD.

Per American Academy of Ophthalmology, dry AMD occurs when parts of the macula get thinner with age and tiny clumps of protein grow. Although dry AMD is the most common form of AMD, there are no approved therapies in the United States and Europe to treat this condition.

On the other hand, wet AMD occurs when new, abnormal blood vessels grow under the retina, which in turn leak blood or other fluids, scarring of the macula. Anti-VEGF drugs help in treating wet AMD by reducing the number of abnormal blood vessels in the retina apart from laser therapy.

Drugs Available

A number of drugs have been made available to treat this disorder. The leading among them is Regeneron’s Eylea.  The drug is approved for the treatment of wet AMD, diabetic macular edema (DME), macular edema following retinal vein occlusion among others. Sales of the drug in the United States came in at $3.3 billion in 2016, up from $2.7 billion in 2015 which highlights the huge market potential of this indication. Regeneron currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Novartis AG’s NVS/Roche’s Lucentis is also an anti-VEGF therapy approved for various ocular indications, which includes neovascular age-related macular degeneration, visual impairment due to DME among others. Novartis currently carries a Zacks Rank #3 (Hold).

Roche’s Avastin is also used for wet AMD. Roche currently carries a Zacks Rank #3. 

Pipeline Candidates

Given the huge potential of the market, several companies have a host of candidates lined up in their pipelines. Novartis is developing RTH258 (brolucizumab) for wet AMD. The candidate is expected to pose competition to Eylea. Earlier in 2017, Novartis released positive data on RTH258. The candidate met the primary and key secondary endpoints in two phase III studies, HAWK and HARRIER. However, Novartis expects to complete the pharmacokinetic study with the final manufacturing process to enable filing in 2018. Hence, the candidate is not likely to hit markets before 2019 giving Eylea a breather.

Allergan plc AGN is also developing Abicipar pegol (anti-VEGF-A-DARPin) for wet AMD and related conditions.  The company also has other candidates like bimatoprost SR, brimonidine SR for dry AMD. Allergan currently carries a Zacks Rank #3.

Meanwhile, Ophthotech is also developing Zimura in combination with an anti-VEGF drug for the treatment of wet AMD in treatment-naïve patients.  Ophthotech currently carries a Zacks Rank #3.

 

Medical Sector 5YR % Return

Medical Sector 5YR % Return

Bottom Line

Given the potential in the AMD market, and the number of companies developing treatments for the same, we expect investors to keep an eye on new approvals.

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Roche Holding AG (RHHBY) : Free Stock Analysis Report
 
Allergan PLC. (AGN) : Free Stock Analysis Report
 
Novartis AG (NVS) : Free Stock Analysis Report
 
Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report
 
Ophthotech Corporation (OPHT) : Free Stock Analysis Report
 
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