Bio-Tissue has been in the amniotic membrane space for more than 30 years, pioneering its use in ophthalmology. And, thankfully, we have this wonderful regenerative platform with PROKERA’s cryopreserved amniotic membrane, which is the only product recognized by the FDA as having anti-inflammatory, anti-scarring, and anti-angiogenic properties. In the fetal environment, the amniotic membrane exists to serve and protect; on the eye, it promotes healing and protects from infection, scarring, haze, and inflammation. That’s very important for many applications.

Technology and Clinical Use

The extracellular matrix (ECM) components found in cryopreserved amniotic membrane regulate and promote regenerative tissue processes.^1-3 In a head-to-head comparison between cryopreserved and dehydrated amniotic membrane, only cryopreservation maintained the quantity, quality, and activity of fresh amnion’s key biosignaling factors (Heavy Chain-Hyaluronic Acid/Pentraxin3).⁴ Dehydration changes the heavy chain hyaluronic acid to the light chain hyaluronic acid, which is known to be pro-inflammatory, so it doesn’t have the same clinical efficacy. The spectrum of clinical uses for PROKERA ranges from moderate corneal-involved dry eye disease all the way up to chemical burns and stem cell dysfunction. Any condition that disrupts the corneal surface, whether it’s a disease state or iatrogenic problem, is a potential use for PROKERA.

We commonly treat dry eye using PROKERA in our practice. In one study, dry eye patients with "pain and stain" had significantly better symptoms and increased corneal nerve density with PROKERA.⁵ Another study of frustrated dry eye patients with "pain but no stain," also known as neuropathic corneal pain, showed that 3 to 7 days with PROKERA produced a statistically significant reduction in pain by 73% on average.⁶ Finally, in the DREAM study, patients using PROKERA were compared to patients with other standard dry eye therapies. All signs and symptoms were significantly more improved in patients using PROKERA at 1 month and out to 3 months.⁷

We also use PROKERA often in our practice after cross-linking to prevent infection and inflammation and control pain. We also prescribe an antibiotic, a steroid, and an NSAID. We could use a bandage contact lens, however, PROKERA supports all of these goals: it is anti-inflammatory, it helps the eye to heal, and it prevents and/or reduces hazing and scarring.

In my experience, patients using PROKERA don’t complain about the ring. Their symptoms are reduced. They feel better. The corneal nerves continue to regenerate, which will help the cornea and ocular surface remain healthy. Infection is rare, even in patients who have had herpes simplex in the past. It’s an exceptional technology that allows us to help patients in ways that were simply not possible in the past. ❖

References

1. Rinastiti M, et al. Histological evaluation of rabbit gingival wound healing transplanted with human amniotic membrane. Int J Oral Maxillofac Surg. 2006; 35:247-251.
2. Jin CZ, et al. Human amniotic membrane as a delivery matrix for articular cartilage repair. Tissue Eng. 2007;13:693-702.
3. Niknejad H, et al. Properties of the amniotic membrane for potential use in tissue engineering. Eur Cell Mater. 2008;15:88-99.
4. Cooke M, et al. Comparison of cryopreserved amniotic membrane and umbilical cord tissue with dehydrated amniotic membrane/chorion tissue. J Wound Care. 2014 Oct;23(10):465-474, 476.
5. John T, et al. Corneal Nerve Regeneration after Self-Retained Cryopreserved Amniotic Membrane in Dry Eye Disease. J Ophthalmol. 2017; 2017:6404918.
6. Morkin MI, et al. Efficacy of self-retained cryopreserved amniotic membrane for treatment of neuropathic corneal pain. Ocul Surf. 2018;16(1):132-138.
7. McDonald MB, Sheha H, Tighe S, et al. Treatment outcomes in the DRy Eye Amniotic Membrane (DREAM) study. Clin Ophthalmol. 2018;12:677-681.