Enrollment complete in Cambium dry eye study
The final patient has been enrolled in a phase 1/2 study of Elate Ocular topical fibrinogen-depleted human platelet lysate biologic for the treatment of dry eye secondary to graft-versus-host disease, Cambium Medical Technologies announced in a press release.
The randomized, multicenter, double-masked, placebo-controlled parallel study enrolled 66 patients at nine centers. There are two study biologic cohorts and a placebo cohort.
“Cambium remains on track for Elate Ocular to be the first standardized, cGMP processed, allogeneic, enriched platelet-rich-plasma lysate serum drop approved for any dry eye indication,” Terry Walts, president and CEO of Cambium, said in the release. “We selected oGvHD because of its need, because there is no approved therapeutic for oGvHD to date and to intentionally assess Elate Ocular among one of the severest of patient populations as a statement of the biologic’s potential. We believe a complex, multicomponent therapeutic like Elate Ocular may be required to better address the complex, multifactorial nature of dry eye.”