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FDA allows Cambium dry eye study to proceed
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The FDA notified Cambium Medical Technologies that its phase 1 study of topical fibrinogen-depleted human platelet lysate for treatment of dry eye disease can proceed, according to a company press release.
Cambium filed an Investigational New Drug Application in late August for this potential early phase efficacy trial.
“We are delighted this study is about to start,” Terence Walts, president and CEO of Cambium, said in the release. “We continue to believe the potential for a standardized, commercialized, allogeneic (vs. autologous) and eventually FDA-approved growth-factor enriched biologic for dry eye remains significant. It is possible therapies with not one a.i. but numerous nutritive/regenerative components targeting not one but several dry eye etiologies will eventually help clinicians better address the often de-habilitating symptoms of dry eye and among a broader patient population.”
With support from AventaCell BioMedical Technology Corp., Cambium hopes to begin enrollment at up to five U.S. clinical sites later this year.