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First patient enrolled in platelet lysate biologic trial for dry eye with graft-versus-host disease
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Cambium Medical Technologies has enrolled the first patient in a phase 1/2 study of its treatment for dry eye secondary to graft-versus-host disease, the company announced in a press release.
The randomized, multicenter, double-masked, placebo-controlled parallel study will enroll 60 patients at five U.S. sites to evaluate the safety and efficacy of Elate Ocular, a topical fibrinogen-depleted human platelet lysate biologic.
“To our knowledge, our study is the first to evaluate a standardized, cGMP processed, allogeneic vs. autologous, enriched platelet-rich-plasma lysate serum drop in a U.S. IND-sanctioned dry eye clinical trial,” Terence Walts, Cambium president and CEO, said in the release. “The industry already recognizes autologous and PRP serum as generally proven therapies to treat the symptoms of not only dry eye but numerous additional corneal diseases and conditions. To date, however, their use has been largely relegated to end-stage, failed meds status for inherent reasons unrelated to efficacy. Cambium believes, following approvals, its Elate Ocular product has potential as a main-stage, first-line therapy for many corneal diseases and conditions.”
Two sub-studies could increase the number of subjects in the overall study to 108, the release said.