FDA Grants Fast Track Designation to Ohr Pharmaceutical's Squalamine Eye Drops for the Treatment of Wet AMD
Monday, May 14, 2012 | Retina
Ohr Pharmaceutical, Inc., announced that its Squalamine Eye Drops, a potent inhibitor of multiple growth factors implicated in angiogenesis, has been awarded fast track designation by the FDA for the potential treatment of wet AMD. Ohr recently presented data from a key biodistribution and safety study at the ARVO annual meeting, which highlighted the potential therapeutic value of the Squalamine eye drop program in treating wet-AMD and ophthalmic neovascular disorders. The results indicated the following:
• Rapid uptake to the posterior sclera/choroid ocular tissues with slow tissue clearance
• Sustained Squalamine concentrations well above threshold anti-angiogenic levels, which persist throughout the period in between doses ("trough level")
• Safety to ocular tissues with no signs of ocular adverse clinical findings, consistent with previous longer term toxicity studies
• Negligible systemic uptake which minimizes the potential for systemic adverse events
In an interview with Eyewiretoday.com, Irach Taraporewala, President and CEO of Ohr, talked about the unique characteristics and benefits of Squalamine.
“The drug actually diffuses from the front of the eye to the back without going through the aqueous humor, so it doesn’t penetrate all the corneal layers in going to the aqueous humor. And that is important because on long-term use, the drug would not contact the lens of the eye, and therefore not have the propensity to cause cataracts,” Dr. Taraporewala said. “Additionally, since the drug is not intravitreally injected, it would essentially remove all the inherent risks that come with current standards of therapy.”
The fast track designation is designed to facilitate the development and expedite the review of drug candidates intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
Dr. Taraporewala said that a phase 2, randomized placebo-controlled study examining Squalamine is slated to begin in the third quarter of 2012.
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