Topical Solution Shows Promise for Dry Eye Secondary to GvHD

Journal Highlights

Ophthalmology Science, September 2022

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In a pilot trial, Sugar et al. evaluated the safety and tolerability of two concen­trations of a topical ophthalmic solu­tion for the treatment of dry eye disease secondary to graft-versus-host disease (GvHD). They found that the solution, known as CAM-101, was well tolerated and showed no significant toxicity.

CAM-101 is a fibrinogen-depleted human platelet lysate solution prepared from pooled human platelet apheresis products. For this phase 1/2 study, 64 participants from nine U.S. centers were randomized 1:1:1 to placebo control (n = 22) or to 10% (n = 20) or 30% (n = 22) CAM-101. Drops were administered four times daily, one drop in each eye, for 42 days. Primary out­comes were ocular and systemic adverse events and the number of participants with any abnormal clinically significant findings at day 42, as compared with baseline. Secondary outcomes were effi­cacy endpoints, including reductions in ocular discomfort from baseline to day 42 and findings on fluorescein corneal and lissamine green conjunctival stain­ing and tear break-up time. Following this, those in the control group were offered 42 days of open-label treatment with CAM-101 30%.

Of the 64 participants initially enrolled in the trial, 54 completed the study according to the protocol. For the 10 who dropped out, the primary rea­son given for withdrawal was a change in systemic medications indicated by a change in their underlying GvHD.

Results showed that both concentra­tions of CAM-101 were safe and well tolerated, with no indications of tox­icity. Statistically significant improve­ment in some dry eye symptoms were observed in those treated with the 30% concentration. The objective findings of corneal and conjunctival staining were not statistically significant, although there was improvement in tear break-up time.

The original article can be found here.