Cryopreserved amniotic membrane showed efficacy in treating severe dry eye disease refractory to multiple conventional treatment options.
In a study involving 10 clinical sites, 84 patients (97 eyes) received cryopreserved amniotic membrane (CAM) treatment (Prokera Slim, Bio-Tissue) for dry eye disease nonresponsive to maximal therapy with artificial tears, cyclosporine, serum, antibiotics and steroids.
CAM was applied for an average of 5 days (range 2 to 11) and was well tolerated in all but four eyes, from which it was removed after 2 days.
After removal, 74 (88%) of the patients showed significant improvement of the ocular surface and reduction of dry eye symptoms. According to the Dry Eye Workshop ocular discomfort severity score, there was a mean improvement from 3.0+0.8 at baseline to 1.3+0.7 at 3 months.
Inflammation has been recognized as a key component of dry eye disease, and CAM is well known for its potent anti-inflammatory effects.
In the treatment of dry eye it acts through three mechanisms, the authors noted. First, it is a therapeutic bandage that keeps the eye moist and protects the ocular surface. Second, it controls ocular inflammation. Third, it promotes regeneration of corneal nerves, which may explain its lasting effect.
“This notion is supported by the fact that nerve growth factor is abundantly present in CAM and is known to play an important role in nerve regeneration and epithelial healing,” the authors wrote.
Conventional anti-inflammatory therapies, such as corticosteroids, cyclosporine and nonsteroidal anti-inflammatory drugs, have the opposite effect of compromising corneal nerves, which may be the cause of poor response in some cases.
In conclusion, CAM was proven to be a promising treatment to recover ocular surface health.
The authors suggested that it should be used earlier when patients do not respond to topical medications. In these cases, they suggested, “it may be advisable to reduce the number and frequency of concomitant medications to minimize potential toxicity, economic burden and impact on quality of life.”
"As the director of our dry eye center of excellence at the Ophthalmic Consultants of Long Island, I insert at least one Prokera Slim every day, often two or more,” lead author Marguerite B. McDonald, MD, FACS, told Primary Care Optometry News. “On a recent day, I inserted six. When the fetal healing power of the cryopreserved amniotic membrane is unleashed, the results are impressive. I use it for recalcitrant dry eye as well as nonhealing epithelial defects, sterile ulcers and a host of other conditions." – by Michela Cimberle
Disclosures: McDonald is a consultant and member of the speakers bureau of Bio-Tissue Inc. Please see the full study for remaining authors’ financial disclosures.