Topical Fibrinogen-Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs. Host Disease

For patients who do not find relief from other modes of therapy, autologous serum tears have been used as an alternative therapy since the mid-1980s. Limitations such as the need for periodic blood draws, the lack of standardization in the preparation of AST and platelet-enriched plasma tears, the unknown shelf life of AST preparations, the use of non-preserved multi-dose packaging and the practical difficulties patients face in storing these products frozen or refrigerated have hindered their widespread use for treating GvHD and other forms of severe tear deficiency. To address these shortcomings, Cambium Medical Technologies, LLC has developed a proprietary method of standardizing and manufacturing a fibrinogen-depleted standardized platelet lysate using pooled human platelet lysates (phPL) collected from qualified healthy donors (CAM-101). Because Cambium's proprietary manufacturing process depletes pooled human platelet lysates of fibrinogen (the key clotting protein in platelets), the remaining product contains enriched levels of several key nutritive and regenerative components than are normally found in non-standardized AST as well as healthy tear film. Given the multi-factorial nature of DED, the enriched levels of numerous key nutritive components in CAM-101 may well prove to be superior to artificial tears and certain single active ingredient products which treat only one cause or contributor of dry eye (e.g., inflammation) and other forms of tear deficiency.