Use of autologous serum eyedrops for the treatment of ocular surface disease: first US experience in a large population as an insurance-covered benefit.

Abstract

A utologous serum eyedrops (ASEs) were first reported in the treatment of ocular disease in 1975 and have since been investigated in numerous ocular surface disorders. There are few studies from the United States, yet we know anecdotally that ASEs are used in tertiary care centers across the country. The lack of publicity about ASEs in the United States is, in large part, owing to unique barriers in implementing serum eyedrops as a standard treatment modality: laboratories must follow a manufacturing protocol in compliance with regulatory measures, patients must undergo phlebotomy, and patients must cover the cost. We report here a retrospective review of the first experience with ASEs in a large US patient population as an insurancecovered benefit. We conducted a retrospective record review of all Kaiser Permanente Northern California (KPNC) members (population base of 3.2 million) who began treatment with ASEs for various ocular surface disorders from July 1, 2009, to June 30, 2010, by 11 KPNC cornea specialists. This study population represented all patients who received ASEs for the first time during the initial year in which ASEs were a covered benefit. The serum was collected at approved KPNC laboratories and prepared by Leiter’s Compounding Pharmacy, San Jose, California. Institutional review board approval was granted by KPNC and the University of California, San Francisco Committee on Human Research. Of the 103 patients treated during the study period, 18 were excluded because of prior use of ASEs and 12 were excluded for insufficient medical records, leaving 73 patients included in the study. There were 55 women and 18 men, with a mean age of 65 years. Sixtynine patients received ASEs at a concentration of 100%. While many diseases were treated with ASEs, the leading indication for use was dry eye (Table). Among these patients with dry eye, who were typically recalcitrant to other treatments and often had concurrent indications, we identified 30 patients who had a follow-up visit within 90 days of initiating treatment with ASEs. In this group, 16 patients at the first follow-up visit and 11 at the last visit reported an improvement in symptoms with ASEs (average duration of treatment with ASEs, 8.8 months). Improved corneal staining was noted in 12 of these patients at the follow-up visit and in 13 at the last visit with ASEs. Additionally, topical lubrication use in this group decreased from 25 patients at the initial visit to 15 patients at the follow-up, and topical steroid use decreased from 10 patients to 5 patients (Figure). Seven of the 10 patients with persistent epithelial defects healed with the use of ASEs. The defect had been present for an average of 63 days prior to starting ASEs, and they healed within an average of 42 days. Of the 3 patients whose conditions did not resolve, 2 had perforation during the study period and 1 was lost to followup. We did not find a correlation between the duration of the defect prior to use of ASEs and the time to resolution (R = 0.07). Two patients reported transient discomfort with use of the ASEs. We believe this represents the first study in which ASEs have been introduced as an insurance-covered benefit to a large and diverse US patient population. Our review supports previous reports on the safety and efficacy of ASEs, as many patients with recalcitrant dry eye symptoms improved with treatment by ASEs and used fewer local treatments. The continued availability of ASEs may lower the threshold for KPNC members to receive ASEs, and further studies will provide us with information as to whether patients with less advanced disease or who re-