Ohr Pharmaceutical Inc starts phase III eye drug trials
The group reached an agreement on the special protocol assessment (SPA) with the US Food and Drug Administration (FDA) on the design of Phase III trials for its squalamine lactate ophthalmic solution 0.2% (OHR-102).
The two planned phase III global clinical studies will evaluate the efficacy and safety of OHR-102 for use against ophthalmic diseases.
The first of two randomized double-masked placebo-controlled trials will include around 165 centers in the US and Canada.
The endpoint of the trial is change in visual function after nine months.
'The initiation of our Phase III clinical program is a monumental achievement for the company and represents an important step in our mission to develop and commercialize therapeutics for unmet medical needs in ophthalmology' said chief executive Dr Jason Slakter.
Shares were up 7% on the news to US$3.05.
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