Next generation of PROKERA biologic corneal bandage devices

Take home

The next generation of biologic corneal bandage devices can reduce inflammation and promote healing for an extended range of ocular surface conditions from mild to severe.

By Nancy Groves; Reviewed by Brandon Ayres, MD

Philadelphia-Two new biologic corneal bandage devices in Bio-Tissue Inc.’s Prokera product line expand the therapeutic options across the full spectrum of severity. The Prokera Slim and Prokera Plus have joined the original corneal bandage device, offering clinicians choices for corneal and ocular surface treatment from the most mild to extremely severe indications.

The bandage devices-which are approved by the FDA-incorporate human amniotic membrane processed with a proprietary method of cryopreservation that retains the tissue’s biological activity to control inflammation, promote healing, and minimize scarring for ocular surface and corneal wound healing. The membrane is contained within a thermoplastic ring set, and, according to Brandon D. Ayres, MD-who is with the Corneal Service at Wills Eye Hospital in Philadelphia-this is where the improvements were made to expand the utility of the devices.

Understanding the devices

The thickness of the ring in the Prokera Slim has been reduced by about half, which makes it more comfortable for patients to wear and thus improves their acceptance of this treatment option, Dr. Ayres said. The amniotic membrane is fixated in the thermoplastic ring in a way that ensures maximal contact on the ocular surface, which in turn creates clinical benefits and enhances comfort.

Since the introduction of the two new devices, Dr. Ayes has turned to the slim design almost universally, for cases from dry eye to corneal ulcers, and has seen it make a dramatic difference in patients’ symptoms. He likened the bandage device to a “biologic cocoon” that can protect the eye and promote healing, with the benefits lasting a month or more.

“Because of the improvement in comfort with the Prokera Slim, that’s what I use with most of my patients, and I am much more willing to use the device,” he said.

 In the treatment of dry eye, for example, the corneal bandage might be a good option if a patient has failed other commonly used therapies, such as artificial tears or topical cyclosporine.

The other new product, the Prokera Plus, has double the thickness of the original due to multiple layers of amniotic membrane and also has extended duration, and it can remain on the eye on average for 7 to 14 days.

 “The idea is to use the double strength device for the most severe cases in which you need the protection for a longer period of time,” Dr. Ayres explained.

This would be the device to turn to for patients with significant inflammation from conditions such as infectious keratitis, chemical burns, or Stevens-Johnson syndrome, he added.

“I use Prokera Plus to decrease the inflammation and promote healing after the infection is under control,” Dr. Ayres said.

The original Prokera corneal bandage is still available and is recommended for patients with moderate to severe indications such as neurotrophic ulcers, severe infectious keratitis, bullous keratopathy, or following high-risk corneal transplantation.

Dr. Ayres said his experience with the original Prokera bandage and now the new generation of products has convinced him that they are effective and will result in clinical improvement in the majority of cases. He explained that the healing effect of the amniotic membrane is unique and promotes tissue regeneration. The devices do not just provide a barrier function, as would a bandage contact lens. Instead, they could be termed biological contact lenses because their active component, the amniotic membrane, decreases inflammation and promotes healing.

“When patients really need help, Prokera comes through,” Dr. Ayres said.

Bio-Tissue introduced the two new bandage devices at the American Academy of Ophthalmology annual meeting last fall.

Brandon Ayres, MD

E: brandonayres@me.com

Disclosures: Speaker board for Alcon, Allergan, Bausch+Lomb, Bio-Tissue. Consultant for Nicox.

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