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Product offers improvement in objective dry eye disease measures, providing relief.
This article was reviewed by Neera S. Jagirdar, MD, MPH
Topical fibrinogen-depleted human platelet lysate (FDhPL; Elate Ocular; Cambium Medical Technologies) is safe, well tolerated and provides symptom relief for patients with dry eye disease secondary to graft-vs-host disease, according to Neera S. Jagirdar, MD, director of Medical, Clinical and Regulatory Affairs at Cambium Medical Technologies in Smyrna, Georgia.
Ocular graft-vs-host disease is a severe form of tear deficiency that develops in approximately 60% to 90% of patients with chronic graft-vs-host disease following allogeneic hematopoietic stem cell transplantation.
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Autologous serum tears (AST) and platelet-rich plasma have been used for decades as treatments, but they are associated with a number of disadvantages, such as high cost, no insurance coverage, need for periodic blood draws, and lack of standardization in treatment preparation.
In addition, the shelf life of these preparations is unknown, and they need nonpreserved, multidosed packaging, resulting in practical difficulties regarding storage, freezing, and refrigeration.
These factors have prevented the widespread use of these treatments, she explained.
This formulation provides consistent product quality, ease of use and storage, convenience, and noninvasiveness, Jagirdar said. It is a cell-free preparation that uses pooled human platelet lysates collected from qualified healthy donors.
The manufacturing process depletes pooled human platelet lysates of fibrinogen; the final product contains enriched levels of key nutritive and regenerative components normally found in nonstandardized AST and healthy tear film.
“The enriched levels of these key components may prove to be superior to artificial tears and certain single active ingredient therapies that treat only 1 cause of or contributor to dry eye and other forms of tear deficiency,” Jagirdar said.
After a 2-week run-in, 64 patients were enrolled and randomized to receive 1 drop in each eye of 30% FDhPL (n = 22), 10% FDhPL (n= 20), or control vehicle (n = 22) 4 times daily in a phase 1/2 randomized, placebo-controlled 42-day study. Patients were evaluated on days 21 and 42.
On day 42, the respective numbers of patients that completed the study were 19, 17, and 18, respectively. Following this, 17 patients randomly assigned to the control group were rolled over into an open-label group to receive the 30% FDhPL for another 42 days.
The safety and tolerability of the 2 concentrations of the active treatment compared with the controls in patients with dry eye secondary to graft-vs-host disease.
The secondary outcome was the efficacy of the 2 concentrations compared with each other for treating these patients in the Ocular Surface Disease Index (OSDI) scores, visual analog scale (VAS), and fluorescein and lissamine green conjunctival staining.
Jagirdar reported that the 30% and 10% formulations were safe; only 2 treatment-related ocular events occurred: burning and stinging on instillation with the 10% concentration and the vehicle control.
On day 42, using the 0-to-100 scale of the VAS, on which 0 indicates “never” and 100 “constantly,” 30% FDhPL yielded key decreases in the frequency of eye discomfort (mean decrease [MD], 30.2; P < 0.001), dryness (MD, 25.92; P = 0.020), pain (MD, 16.97; P = 0.044), photophobia (MD, 35.53; P = 0.0125), grittiness (MD, 14.06; P = 0.0185), burning and stinging (MD, 26.62; P = 0.045), and ocular discomfort (MD, 20.73; P = 0.018) compared with the control.
Itching and foreign-body sensation also were reported to decrease but not significantly so. Changes also were seen in the active treatment groups in the total OSDI scores, tear film break time, and tear osmolarity.
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The percentages of patients who showed improvement on day 42 in the 30% treatment groups among the various parameters studied were as follows: tear break-up time, 59.1%; VAS itching, 72.7%; VAS eye discomfort, 90.9%; VAS grittiness, 63.6%; ocular discomfort, 77.3%; and global examination, 72.7%.
“The study showed that the drug, and especially the 30% concentration, compared to the vehicle, was safe, tolerated, provided symptom relief, trended toward improvement in objective dry eye disease measures—and may be a convenient, consistent alternative to autologous serum and plate-rich plasma,” Jagirdar said. “The product is easy to use and store, convenient, noninvasive and does not require blood draws.”