Eye Drop to Treat Wet Macular Degeneration Granted Fast Track Designation by FDA
June 14, 2012
Last month, Ohr Pharmaceutical Inc (Nasdaq: OHRP) announced that its Squalamine Eye Drop formulation was awarded Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of the wet form of macular degeneration (wet-AMD).
According to Ohr’s CEO, the Fast Track designation underscores the importance of developing an eye drop designed for self-administration for the treatment of wet-AMD. Clearly, self-administrating eye drops to treat wet AMD is preferable over regular intravitreal injections of Roche/Genentech’s Lucentis(R) or Avastin(R), or Regeneron’s Eylea(R), directly into the eye.
Ohr recently presented data from a key study at the ARVO 2012 Annual Meeting, which highlighted the potential therapeutic value of the Squalamine eye drop program in treating wet-AMD and ophthalmic neovascular disorders. The preclinical testing demonstrated that the eye drop formulation is both safe to optical tissues and achieves in excess of target anti-angiogenic concentrations in the tissues of the back of the eye.
The company anticipates commencing a Squalamine Eye Drop phase II clinical trial in the third quarter of 2012.
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