The U.S. Food and Drug Administration (FDA) has seen fit to award Fast Track status to Ohr Pharmaceutical’s Squalamine Eye Drops, according to a press release detailing the situation.
The press release noted that the biotechnology company’s promising drug got the FDA’s nod on account of its potential as a medication for those diagnosed with the wet type of age-related macular degeneration (AMD).
Commenting on the recent development, Ohr Chief Executive Officer Dr. Irach B. Taraporewala said in the press release that the FDA’s decision to grant Fast Track designation to the Squalamine Eye Drops demonstrates just how crucial it is to come up with new ways to help those living with wet AMD.
He added in the press release that Ohr’s eye drop drug not only could meet a need among a formidable and increasing population living with wet AMD, but also could prove particularly beneficial to people who presently have to undergo chronic intravitreal injections of either Regeneron’s Eylea or Roche/Genentech’s Lucentis directly into their eyes. He added that the company is excited about how the program is going and is looking forward to commencing a phase II Squalamine Eye Drop clinical trial during the third quarter of this year.
According to the press release, Ohr, while at the ARVO 2012 Annual Meeting recently, presented findings for an important safety and bio-distribution study. The data focused on the therapeutic potential of Ohr’s eye drop initiative in helping those with wet AMD conditions and ophthalmic neovascular issues.
Some of the results the company presented follow:
- Quick uptake to posterior sclera/choroid ocular tissues with less-than-quick tissues clearance
- Scant systemic uptake, which lessens possibility for systemic negative events
According to the press release, the FDA’s Fast Track designation was designed to aid the development and quicken the review of medicine options created to treat conditions thought to range from critical to life-threatening. Drug candidates must also demonstrate reasonable prospect of filling an unmet medical need. Any drug that warrants Fast Track status also qualifies for Accelerated Approval and Rolling Review, which provides for the submission of separate New Drug Application sections.