Roche Holding Ltd. (ADR) (RHHBY), Novartis AG (ADR) (NVS): Should You Keep an Eye on These Eye Treatment Biotechs?

The main criticism is that Ampio Pharmaceuticals Inc (NYSEMKT:AMPE)’s “Phase III” trials should actually be classified as Phase II trials, due to the efficacy and safety data gathered from the trial. In addition, Ampio’s planned clinical study for Ampio is intended for a 12-week period on 450 DME patients. To date, the FDA has never approved a DME treatment based on the results of a 12-week trial.

Lucentis was only approved as a DME treatment after two Phase III studies showed significant improvement in patients. Regeneron Pharmaceuticals Inc (NASDAQ:REGN)’s Phase III trials for using Eylea as a DME treatment are measuring vision improvement over a two-year period. Therefore, Ampio Pharmaceuticals Inc (NYSEMKT:AMPE)’s statement that a 12-week trial would eventually lead to FDA approval is a very weak claim.

A Foolish final thought

It’s a fact that the number of AMD and DME cases will increase annually as a result of an aging world population and rising diabetes rates. However, it’s unknown if any of these new treatments can offer any real advantages over Avastin. The slowdown in Eylea sales last quarter indicates that many patients are switching over to the cheaper alternative instead. Yet, that discouraging data hasn’t stopped companies like Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Ampio Pharmaceuticals Inc (NYSEMKT:AMPE) from betting heavily that these expensive treatments could become a reliable source of future revenue growth.

In closing, investors should carefully watch the fluctuation in demand between the angiogenesis inhibitors (Lucentis and Eylea) and Avastin to see if these eye treatments are truly worth all the Wall Street hype that has been showered upon them.

Leo Sun has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned.

The article Should You Keep an Eye on These Eye Treatment Biotechs? originally appeared on Fool.com.

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