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.
Read more here and on the company’s website.
- Ohr Pharmaceutical Launches Clinical Trial to Evaluate Squalamine Eye Drops for Wet AMD
- Sirion Therapeutics Announces Positive Results from Phase II Trials Evaluating Fenretinide for Treatment of Geographic Atrophy and Receipt of Fast Track Designation from the FDA
- Ohr Pharmaceutical Announces Positive Preclinical Safety Study Results for Squalamine Eye Drop for Wet-AMD
- Drugs to Treat Both Leber Congenital Amaurosis and Retinitis Pigmentosa Fast Tracked by FDA
- ARVO 2009 Presentations – StemCells, Inc.
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I just can’t believe if their are no side affects why the eye drops are takiing so long for FDA approval we that are diagnosed and don’t want shots in our eyes because of side affects are slowly losing our sight. I am begging someone to please do something.
you have to understand that it takes months-years to get these trials approved, then months-years to actually conduct the study, so that it can be compared to the standard injection treatment. the fda is notoriously slow in general and very conservative. i agree it stinks.