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Ocata receives EMA guidelines for Stargardt macular degeneration trial
Ocata Therapeutics received written formal guidance from the European Medicines Agency to initiate a clinical trial for its Stargardt macular degeneration program, according to a press release.
The company intends on enrolling approximately 100 patients in the trial and including an untreated control arm based on guidance from the FDA.
Ocata was previously granted advanced therapy medicinal product designation for its retinal pigment epithelium treatment for macular degeneration and has orphan status in Europe and the U.S. for the Stargardt macular degeneration program, the release said.
“We are pleased with the guidance we’ve received from the European Medicines Agency, which means that our [Stargardt macular degeneration] program can be initiated as a pivotal clinical trial, potentially allowing us to apply for marketing authorization upon its completion,” Paul K. Wotton, president and CEO of Ocata, said in the release.