Acucela Drug for Macular Degeneration Passes Early Safety Test
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earlier-generation compounds from a class of retinoid drugs, Kubota says. The newer drug candidate is a non-retinoid compound, he says.
“We could slow down the accumulation of toxic byproducts in the retina,” Kubota says. “This is a groundbreaking result.”
There are other companies that hope to make similar claims. Tampa, FL-based Sirion Therapeutics announced last month that its experimental drug, fenretinide, was able to reduce the growth rate of lesions in a Phase II clinical trial of patients after six months, and the effect increased over time. Othera Pharmaceuticals of Exton, PA also has generated some buzz in the ophthalmology world, with positive results from a trial that suggested its eye drop for the dry form of macular degeneration was able to help slow down the rate of vision loss.
Acucela is planning its next steps to amass the kind of convincing evidence ACU-4429 will need to become a competitive treatment, Kubota says. Acucela, along with its partner, Japan-based Otsuka Pharmaceuticals, plan to start a preliminary Phase II clinical trial this summer of 30 to 40 patients that will examine whether the treatment can slow down the visual cycle, a measurement thought to be an early indicator of whether a drug can successfully help preserve vision. Then, the company will advance to a larger Phase II trial that will run 18 to 24 months to get a more compelling read on the drug’s effectiveness, Kubota says.
Past years at this meeting have focused mainly on innovation in the wet form of age-related macular degeneration (AMD), although Kubota says he thinks that’s starting to change. “It’s blooming now in the world of dry AMD as well,” he says. “Wet AMD is being targeted now, and the next big thing is dry AMD.”