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OT-551 Development
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Re: OT-551 Development
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MrBill
Re: OT-551 Development
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Apr 24 06 1:13 PM
Here's what Othera told me about OT-551:
I am pleased to inform you that Othera started a small study last fall in patients who have had a vitrectomy during retina surgery, removal of vitreous humor in the back of the eye. Followup of patients after surgery requires one year.
At that time, Othera will be able to make an assessment regarding the effect of OT-551 on development of surgery-related cataracts. Regulatory agencies require that a small study be conducted first to determine the effects of new drugs. When those results become available, pharmaceutical companies generally conduct two larger studies. Such large studies would also require long-term followup of patients. Results of all three studies are then submitted to the FDA regulatory agency for review and a determination is made whether to grant marketing approval.
For Othera, OT-551 results could become available in 2007 for the small study. Studies to support marketing approval or commercialization could be initiated thereafter. And then several years would be needed to obtain results, submit them to a regulatory agency for review, and so forth.
Another study for the treatment of age-related macular degeneration will start shortly. This study will be conducted by the National Institute of Health.
Unless you qualify for participation in one of the described clinical studies, unfortunately the time frame to get the product to the market is not likely to be helpful in your case.
Thank you for your interest in Othera Pharmaceuticals. I hope this information is helpful to your understanding of the process for getting new drugs to the market.
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OT-551 Development
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