Ocugen doses second cohort in trial of OCU410 for geographic atrophy
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Ocugen has announced that dosing is complete in the second cohort of its phase 1/2 ArMaDa clinical trial to assess the safety of OCU410, a modifier gene therapy candidate for geographic atrophy.
“We are very enthusiastic about the potential of OCU410 as a one-time, gene-agnostic option for the treatment of GA,” Huma Qamar, MD, MPH, Ocugen’s chief medical officer, said in a company press release. “OCU410 regulates multiple pathways involved with the disease, including lipid metabolism, inflammation, oxidative stress and membrane attack complex (complement) with a single subretinal injection.”
According to the release, the trial’s first phase is an open-label study conducted at up to 13 U.S. retinal surgery centers to evaluate the safety of 2.5×1010 vg/mL, 5×1010 vg/mL and 1.5 ×1011 vg/mL doses of OCU410. The second phase is a dose-expansion study in which participants will be randomized to one of two treatment groups or an untreated control group. Three participants in phase 1 have received 200 mL single subretinal administration of the medium dose (5×1010 vg/mL) to complete dosing of the second cohort.
A review of the 4-week safety data for the medium-dose cohort will be conducted in May before investigators advance to administration of the high dose, the release stated.
“Currently we have two FDA-approved, anticomplement therapies for GA targeting a single pathway of the disease, which has multifactorial and complex etiology,” lead trial investigator Syed M. Shah, MD, vice chair of research and digital medicine and director of retina service at Gundersen Health System, said in the release. “The limited benefit comes with the burden of continued multiple intravitreal injections spanning over several years. This novel modifier gene therapy has the potential to transform the therapeutic landscape in GA treatment.”
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