BioCorneaVet will be permanently resided in the recipient’s cornea after the remodeling process with more and more transparent cornea matrix without the use of anti-immunological agents anymore 6-12 months after the keratoplasty.But the autologous tissue would have to topically administer anti-immunological agents for a life time. While for the traditional conjunctiva flap with SIS, the optical negative prognosis and scarring are the unsatisfactory points.
BioCorneaVet™ is indicated for use in the treatment of several epithelial corneal defects and diseases including, but not limited to, ocular trauma, deep corneal ulceration, perforation and feline sequestrum formation.
BioCorneaVet™ consists of the extracellular collagen matrix (ECM) derived from porcine cornea. This tissue is procured through a science and technology based method of viral inactivation, decellularization and sterilization (Gamma Radiation).It is recommended to store in a temperature between 2-25°C with 18 months shelf life.
Acellular porcine corneal stroma is prepared by a series of strictly controlled procedures including the removal of antigens such as heterogeneous cells, miscellaneous proteins, and polysaccharides from the cornea whilst retaining the natural corneal matrix collagen scaffold. (Zhang MC, Liu X, Jin Y, Jiang DL, Wei XS, Xie HT. Lamellar keratoplasty treatment of fungal corneal ulcers with acellular porcine corneal stroma. Am J Transplant. 2015;15(4):1068‐1075.)
They were manufactured through a series of viral inactivation and decellularization processes. Porcine eyeballs were recovered from a quarantined pig slaughterhouse, and the porcine corneas were removed from the eyeballs with sclera attached. Then, the corneas were placed in sodium hypochlorite solution for viral inactivation, followed by repeated hypertonic‐hypotonic treatments by alternating the use of NaCl solution and injectable water for decellularization. After dehydration in glycerol, the APCSs were cut into circular discs with different thick‐ nesses (200, 300, 400, and 450 μm) to serve different clinical requirements. The APCSs were then sterilized using Co60 radiation. (Zheng J, Huang X, Zhang Y, et al. Short‐term results of acellular porcine corneal stroma keratoplasty for herpes simplex keratitis. Xenotransplantation. 2019;e12509. https://doi.org/10.1111/xen.12509 )
A protective decellularization strategy is developed for the preparation of decellularized porcine cornea (DPC), in which corneas are treated by detergent and endonuclease in the protective medium with 50 mmHg colloid osmotic pressure. A nonrandomized open‐label trial is conducted to evaluate the clinical outcome of lamellar transplantation with DPC versus human donor cornea (HDC) as grafts. Through the protective corneal decellularization, major xenoantigen DNA and α‐gal are efficiently removed, while corneal original structural and transparency characteristics are preserved. Among the 23 patients with DPC transplantation for 12 months, 22 grafts survive without ulcer recurrence or immune rejection, 1 graft demonstrate melting. Compared with HDC grafts, DPC grafts showed early suture loosing, but no complication is observed with timely removal. The epithelial regeneration rate, graft transparency restoration, best‐corrected visual acuity improvement, and mechanical properties achieve equivalent levels compared with that of HDC grafts. Collectively, the results suggest that the porcine cornea through protective decellularization may provide an effective “off‐the‐shelf” substitute of globally‐shortened human donor tissue for lamellar transplantation. Porcine cornea after decellularization represents a promising alternative source to overcome the shortage of human donors. (Shi Weiyun, Zhou Qingjun and etc. Protectively Decellularized Porcine Cornea versus Human Donor Cornea for Lamellar Transplantation. 2019/07/15,10.1002/adfm.201902491. Advanced Functional Materials)
BioCorneaVet™'s primary surgical method of implantation is by anterior lamellar keratoplasty (ALK or DALK). When covering corneal defects,BioCorneaVet™ promotes host corneal epithelial regeneration and matrix synthesis. Healing results when the cornea is fully restored in the aspects of structure and function as normal cornea.