Cambium Medical Technologies (Cambium) has announced new receipt of results from a Phase I/II study of its Elate Ocular® topical fibrinogen-depleted human platelet lysate. The biologic was tested among dry eye patients with Ocular Graft-vs-Host Disease (oGvHD). In the coming months, Cambium will be presenting study results and a clinical study report will be submitted to the FDA.
Cambium’s current study was a Phase I/II randomized, double-masked placebo-controlled parallel trial enrolled a total of 66 patients at nine U.S. eye centers. It aimed to determine safety and exploratory efficacy in patients with dry eye secondary to oGvHD. Two drug cohorts and a placebo were involved in the study.
The FDA had granted Cambium’s platelet lysate last month with the Orphan Drug Designation, a special status to drugs or biologics demonstrating promise for the treatment of rare conditions.
“Our Elate Ocular® biologic significantly exceeded expectations,” said Terry Walts, Cambium’s President and CEO. “These results are especially impressive given the severe nature of oGvHD. The study’s primary objective was safety. Our results suggest our biologic is very well tolerated. The study also assessed efficacy on an exploratory basis. Of note, we exceeded expectations on many efficacy measures, particularly impressive given safety studies are not generally powered to determine efficacy statistical significance.”
Cambium believes these results, along with orphan drug designation, continue to support Elate Ocular’s® potential for dry eye going forward.