Regenerative medicine company Cellution Biologics recently introduced a next-generation amniotic graft designed for ocular surface protection dubbed OptiCover.
Let’s begin with some background on this company.
Cellution was established in 2024 as a wholly owned U.S. subsidiary of the India-based LifeCell International Private Limited.
- Notably: LifeCell specializes in providing human-based cell and tissue products (HCT/Ps), operates FDA-registered facilities, and is also reported to be the first tissue bank outside the U.S. accredited by the American Association of Tissue Banks for products derived from birth tissues.
And what does Cellution focus on?
As a regenerative medicine company, Cellution is advancing a portfolio of human-tissue-based products designed to support a range of clinical applications.
Among these:
- Wound covers for in-office and hospital use
- Ocular grafts such as OptiPlast and OptiCover (our topic of interest)
And in recent news: Just last week the company celebrated its U.S. headquarters expansion in Roswell, Georgia.
Let’s talk more about OptiCover.
What it is: A dry, lyophilized (freeze-dried) amniotic membrane (AM) disc allograft derived from human AM tissue and intended for in-office ophthalmic use as a protective covering on the ocular surface.
Its purpose: To operate as a next-generation biologic alternative to traditional CAMs for addressing dry eye and ocular surface repair.
And how does it do this?
OptiCover is designed to retain Heavy Chain-Hyaluronan/Pentraxin 3 (HC-HA/PTX3), an anti-inflammatory and anti-scarring complex purified from AM.
- To note: HC-HA/PTX3 acts as a regenerative matrix to heal the ocular surface by:
- Supporting corneal stem cells and reducing fibrosis
- Suppressing inflammation in conditions such as dry eye and corneal limbal stem cell deficiency
In other words: The AM’s proprietary lyophilization process is "specifically designed to preserve the native architecture” of the AM.
Check out its product brochure for more information.
Any technology involved in this?
That would be the AGNES Process Technology, which works by:
- Retaining the spongy layer along with the amnion layers
- Preserving the inherent biological components of native (human) placental tissue
And where does Cellution source the tissue from?
Donated human tissue is reported to be "rigorously screened” to meet strict donor eligibility criteria, with a comprehensive evaluation consisting of:
- A review of infectious disease test results
- Detailed medical history and medical record analysis
- Evaluation of prior lab test results and other relevant data
Take note: This information can be found in OptiCover’s product brochure.
Gotcha. Next: Talk about OptiCover’s design.
Intended for single-use only, the 12-mm AM features a ringless design for enhanced patient comfort as well as easy handling and placement on the ocular surface during procedures.
Other capabilities and properties:
- Room temperature (shelf-stable) storage for convenient, on-demand use.
- Aseptic, sterile processing via gamma sterilization for safety and quality.
- Maintains the natural extracellular matrix to support healing.
- Natural adhesion for placement under a collagen shield or bandage contact lens.
How does it differ from other AM products on the market?
Aside from not requiring ultra-cold storage, OptiCover’s crease-resistance during application is also unique.
This lack of creasing also reduces the potential risk for abrasions while enabling easier placement and position of the membrane during procedures.
And its intended applications?
Two forms of dry eye disease (DED)—mild-to-moderate and glaucoma-medication-induced—as well as:
- Superficial punctate keratitis
- Neurotrophic keratitis stage 1
- Ocular surface optimization
Now, what do we know about OptiCover’s regulatory status?
As an allograft, OptiCover is currently commercially available in the United States as a human cells, tissues, and cellular and tissue-based product (HCT/P)—also referred to as an allograft.
To be precise: It’s marketed and regulated as an allograft under Section 361 HCT/P of the FDA’s Code of Federal Regulations (CFR) 21 CFR 1271.10.
- Under this: Qualifying tissue products are permitted for commercial distribution without premarket FDA approval or clearance if they meet specific criteria.
Is this confirmed?
Indeed. By Cellution’s Jon Werner, vice president of marketing.
Lastly, how can I learn more about adding it to my practice?
We’d recommend reaching out to Cellution directly.