New Data on RTH258 Show Promise

Parth Shah; Sophie J. Bakri, MD


August 24, 2016


With AMD being one of the leading causes of irreversible blindness in the world, it is encouraging to see the potential clinical implications of new therapies like RTH258. Not only did RTH258 achieve noninferiority in the primary efficacy endpoint for 4.5 mg and 6 mg, but there also was an increase in time to PBT. Both of these results are preliminary data that suggest that specific doses of RTH258 may be able to adequately manage neovascular AMD while reducing the number of physician visits, and thereby potentially improving disease progression and patient compliance.

Nevertheless, this study holds some limitations, including the small population size, a 99.5% white study population, and the fact that choice of time to PBT was at the discretion of the investigator. The study results are also based on a single intravitreal injection; it is unknown whether efficacy outcomes and patient tolerability can be maintained after multiple injections. Using BCVA instead of CSFT as the primary efficacy outcome also will become more important in longer studies of RTH258, because the MARINA, ANCHOR, and VIEW 1 and -2 trials all used BCVA as the 1-year primary endpoint.

It will be interesting to see the results of the phase 2 trial of RTH258 (OSPREY trial) and the phase 3 trial of RTH258, which has started enrolling patients.



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