BioTissue Announces First Study to Demonstrate Corneal Nerve Regeneration in Patients with Dry Eye Disease with the Use of Prokera

Company’s Proprietary Cryopreserved Amniotic Membrane Continues to Advance

MIAMI, November 9, 2017 – BioTissue^®, Inc., announced today the publication of “Corneal Nerve Regeneration after Self-Retained Cryopreserved Amniotic Membrane in Dry Eye Disease” in The Journal of Ophthalmology, 2017 (John, et al.), the first study to show that cryopreserved amniotic membrane is correlated with corneal nerve regeneration in patients with dry eye disease (DED). The study results will be presented at the upcoming American Academy of Ophthalmology (AAO) meeting taking place November 11 – 14, 2017 in New Orleans.

In this prospective, randomized controlled clinical trial conducted at the Thomas John Vision Institute, 20 patients with DED were randomly treated with cryopreserved amniotic membrane (Prokera^®), or conventional maximum treatment (control). Prokera was found to be a promising therapy for corneal nerve regeneration and to accelerate the recovery of ocular surface health in patients with moderate and severe DED.

In the clinical trial, patients who completed the one-month and three-month study with cryopreserved amniotic membrane (Prokera) showed significant improvement in their DEWS score, pain score, TFBUT, fluorescein staining, and SPEED score. Further, these patients exhibited a significant increase in central corneal nerve density both at the one- month and three-month periods, and significant improved corneal sensation from a baseline of 3.25 ± 0.6 cm to 5.2 ± 0.5 cm at one-month and 5.6 ± 0.4 cm at three- months. There was also improved corneal surface topography in terms of wavefront aberrations as well as the cylinder that is induced in dry eye patients. These results were confirmed by a masked reader at Tufts Medical Center in Boston.

“These findings are quite significant as this is the first study to demonstrate that cryopreserved amniotic membrane is correlated with corneal nerve regeneration, as evidenced by an increase in corneal nerve density and improved corneal sensitivity,” said Thomas John, MD, Thomas John Vision Institute and co-principal investigator of the clinical trial. “Prior to this study, no therapeutic modality was shown to regenerate corneal nerves, which play a key role in tear film stability and ocular surface health. Consistent with our findings, cryopreserved amniotic membrane controls inflammation and promotes healing and nerve regeneration.”

Prokera is a sutureless, FDA-cleared Type II medical device that is used in office by eye doctors around the world to treat corneal involved dry eye and other ocular surface diseases. Prokera is manufactured using BioTissue’s proprietary CryoTek^® technology, which has been proven to preserve the innate biological and structural properties of the amniotic membrane matrix. The components of this matrix have been demonstrated to support regenerative healing in the eye.

“Unlike competitive products preserved via dehydration, Prokera has been shown to be clinically effective in patients with dry eye disease and other ocular surface diseases, due to the extracellular matrix components, including HC-HA/PTX3, which have been shown to orchestrate regenerative healing,” said Scheffer C.G. Tseng, MD, PhD, Chief Technology Officer, TissueTech. “This study is further evidence of the clinical efficacy of cryopreserved amniotic membrane through the use of Prokera, and specifically its ability to regenerate corneal nerves and accelerate healing of the ocular surface in patients with dry eye disease.”

About BioTissue

BioTissue, a business unit of TissueTech, Inc., develops and markets regenerative therapies that allow eye care professionals to advance the standard of care for treating the ocular surface. Its core products include cryopreserved amniotic membrane and umbilical cord-based tissue with innate therapeutic actions scientifically proven to heal the ocular surface. The Company’s proprietary CryoTek preservation method ensures the tissue retains its biologic activity and healing components. To date, more than 300,000 allografts have been transplanted collectively by BioTissue and sister company Amniox Medical, Inc.