Decellularized basement membrane (DBM) represents an evolution within amniotic membrane–derived therapies for ocular surface disease, particularly in the management of moderate to severe dry eye disease (DED) and persistent corneal epithelial defects (PCED).
DED is characterized by ocular surface inflammation, tear film instability, and epithelial damage, which contribute to impaired corneal healing and increased risk of keratitis.1 Traditional management of DED follows a stepwise approach including lubrication, anti-inflammatory therapy, and biologic tear substitutes, with amniotic membrane transplantation (AMT) reserved for refractory cases.
AMT has demonstrated clinical utility by serving as a biologic scaffold and “bandage,” supporting epithelial regeneration while modulating inflammation and promoting wound healing.2 Recent clinical studies confirm that amniotic membrane–based therapies exert anti-inflammatory effects and enhance epithelial recovery in DED and other ocular surface disorders.1,3
Importantly, AMT products vary based on preservation techniques—namely cryopreserved, dehydrated, and decellularized forms—with differences in extracellular matrix preservation, cellular remnants, and biologic activity that may influence clinical outcomes.3
Overview of decellularized basement membrane
DBM refers to amniotic membrane processed to remove cellular components while preserving the structurally and biologically active basement membrane. This processing eliminates epithelial and stromal cellular elements while retaining extracellular matrix (ECM) architecture critical for ocular surface repair.4
The preserved basement membrane contains key ECM proteins—including collagen, laminin, fibronectin, and glycosaminoglycans—that support epithelial cell adhesion, migration, and proliferation, all of which are essential for corneal re-epithelialization.4,5 These structural and biochemical properties allow DBM to function as an optimized scaffold for corneal wound healing.
Decellularization reduces immunogenicity by removing donor cellular antigens and inflammatory debris, which may otherwise delay healing through immune-mediated responses.6 At the same time, preservation of ECM integrity maintains bioactive signaling pathways that regulate epithelial regeneration and inflammation.4,5
Clinical research on DBM
Recent clinical evidence supports the use of decellularized amniotic basement membrane in ocular surface disease. In patients with PCED and DED, DBM has been shown to promote epithelial healing, enhance cellular adhesion and growth, and reduce ocular surface inflammation.7
Prospective clinical studies using sutureless dehydrated amniotic membrane matrices similarly demonstrate improved epithelial defect resolution and reduced inflammatory burden in ocular surface disease.8
Additionally, multilayer DBM constructs—formed by laminating basement membrane layers without destructive processing—have been developed to enhance scaffold thickness and durability while preserving ECM structure.
These constructs may further improve epithelial healing by increasing structural support and maintaining biologically active surfaces, with emerging clinical data suggesting favorable outcomes compared to traditional amniotic membrane preparations.7
We spoke with Neel Desai, MD, about incorporating DBM into his armamentarium.
AMT has traditionally fallen into two categories: cryopreserved and conventional dehydrated membranes. How do you see DBM products redefining this landscape?
Dr. Desai: For most of my career, amniotic membrane transplantation has meant choosing between two imperfect options. Cryopreserved membranes preserve certain biologically active components, particularly PTX3–HC–HA [heavy chain (HC)-hyaluronan (HA)/pentraxin 3 (PTX3)] complexes, which provide an early anti-inflammatory signal.
However, those products also retain stromal tissue, chorion, and donor epithelial debris. This material must be cleared by the host before true epithelial regeneration can occur, and that clearance process is neither fast nor benign. It requires macrophage activity, phagocytosis, and inflammatory signaling that can delay healing and compromise epithelial quality.
Conventional dehydrated membranes remove biologic activity during prolonged heat processing but retain the same stromal and cellular debris. Clinically, that combination often results in delayed epithelialization, subepithelial haze, and less predictable outcomes. In practical terms, you’re left with the liabilities of retained donor tissue without the benefits of preserved biologic signaling.
Decellularized basement membrane (i.e., BIOVANCE 3L Ocular, DefEYE, Inc.) represents a true third category, as the processing removes all donor cells, stromal components, and chorion, leaving only the native amniotic basement membrane. What remains is a purified scaffold rich in laminin, fibronectin, and collagen—exactly the extracellular matrix proteins epithelial cells require for adhesion and migration.
Clinically, that difference is profound. Instead of asking the eye to clear debris before healing can begin, DBM allows epithelialization to start immediately. Healing is faster, cleaner, and more organized. Decellularization fundamentally changes the biologic behavior. In my experience, this category reframes amniotic membrane use from a temporary biologic patch to a true regenerative scaffold.
How does DBM compare with alternatives such as bandage contact lenses alone, autologous serum tears, or cryopreserved ring-based products in terms of efficacy, patient comfort, and workflow?
Dr. Desai: Bandage contact lenses are passive devices. They protect the epithelium mechanically, but they do not actively promote healing and they introduce infection risk. Autologous serum tears can be helpful in chronic surface disease, but they’re not procedural solutions for epithelial defects or for peri-operative optimization.
Though cryopreserved ring-based products are effective biologically, patient tolerance is a major limitation. Many patients experience significant discomfort for 2 to 3 days, and the retained ring often remains for a week or longer.
That discomfort alone has caused some patients to refuse treatment in their second eye. Additionally, the workflow burden, which includes preparation, placement, follow-up, and removal, adds meaningful friction in a busy practice.
With decellularized basement membrane, I’m seeing epithelial healing that is at least equivalent and often better and faster. Most patients are healed by Day 2 or 3. There’s no retained foreign body, no ring to remove, and no need for repeated reassurance visits.
From a workflow standpoint, placement is dramatically faster and I’m often finished placing an ocular decellularized basement membrane before I would even be done rinsing and preparing a cryopreserved device. Patients leave more comfortable, heal faster, and require fewer post-procedure visits. That combination matters both clinically and operationally.
Many clinicians associate amniotic membranes primarily with post-operative healing. In your experience, where does DBM fit in surgical applications compared with traditional membranes?
Dr. Desai: DBM has expanded the role of amniotic membrane beyond post-operative care into true surgical integration. I, personally, now use BIOVANCE 3L Ocular routinely for superficial keratectomy, primary pterygium surgery, conjunctivochalasis repair, and ocular surface optimization prior to cataract or refractive surgery.
For complex pathology, such as stage 3 neurotrophic ulcers with stromal melt, I still prefer cryopreserved tissue because it can be beneficial in those specific scenarios. However, those cases are relatively uncommon in my practice.
For epithelial-driven pathology and surface reconstruction, DBM provides faster epithelialization, less haze, and greater patient comfort. In primary surgical applications, particularly where surgical efficiency and epithelial quality matter, DBM has become my preferred product.
How do you incorporate DBM into peri-operative management in superficial keratectomy, cataract surgery in compromised ocular surfaces, or LASIK enhancements?
Dr. Desai: This is probably my most frequent use case. Ocular surface disease profoundly affects keratometry and biometry. If you attempt refractive cataract surgery on an unstable surface, the likelihood of refractive surprise is high, particularly with premium intraocular lenses.
Historically, after superficial keratectomy, I would wait 4 to 6 weeks before repeating biometry because epithelial remodeling was slow and unpredictable. With DBM, epithelial closure occurs quickly, often by Day 3, and remodeling begins immediately because there’s no debris clearance phase.
That allows me to repeat biometry at approximately 3 weeks and proceed with surgery soon thereafter. The total delay is reduced from 2 months to about 1 month, while improving refractive accuracy. Clinically, this translates into better outcomes, higher patient satisfaction, and increased eligibility for advanced IOLs. From a practice perspective, it improves efficiency, conversion rates, and confidence in refractive outcomes.
In eyes with prior PK, herpetic disease, glaucoma, or corneal thinning, where complications were noted in a small cohort, how cautious should clinicians be when selecting DBM products?
Dr. Desai: Any eye with a history of grafting, herpetic disease, glaucoma, or corneal thinning requires careful case selection regardless of the membrane used. These eyes carry an elevated baseline risk, and that risk should inform monitoring and follow-up.
That said, I have not observed complications attributable specifically to DBM itself. In my experience, the absence of retained donor tissue may reduce inflammatory burden in these vulnerable eyes. The key is not avoidance, but thoughtful patient selection, closer follow-up, and appropriate adjunctive therapy when needed.
What does the current peer-reviewed evidence tell us about DBM compared with legacy amniotic membrane products?
Dr. Desai: This is an important and often blurred distinction. Conventional dehydrated membranes have a paucity of peer-reviewed clinical outcome data in the ophthalmic literature. There are few rigorous, prospective, peer-reviewed studies evaluating their performance in surface reconstruction, neurotrophic keratitis, or clinical or surgical applications.
Cryopreserved amniotic membranes, by contrast, are supported by a substantial body of peer-reviewed clinical literature. Much of that foundational work established the role of amniotic tissue in ocular surface reconstruction, inflammation control, epithelial healing, and neurotrophic disease.
That said, many of these studies were published more than a decade ago and pre-date the development of newer platform technologies such as decellularized basement membrane. Importantly, while there are positive comparative bench-top scientific studies demonstrating the advantages of decellularized basement membrane over cryopreserved membrane products, to date there are no clinical data comparing cryopreserved membranes against modern decellularized alternatives.
Decellularized amniotic basement membrane has burgeoning peer-reviewed data, beyond just our compelling clinical experience, supporting its use. Published work has evaluated structural integrity, epithelial cell adhesion and migration characteristics,1 and clinical outcomes in settings such as sutureless-glueless pterygium surgery, neurotrophic keratitis, ocular surface reconstruction and persistent epithelial defects.2
These studies align with the favorable epithelialization profiles and clinically meaningful and convincing outcomes I’ve been seeing since making this evolution in my own practice patterns.
Final thoughts
In conclusion, the field would benefit from direct, prospective, head-to-head clinical comparisons between cryopreserved and decellularized basement membranes.
To that end, we are currently developing what will be the first prospective comparative study evaluating decellularized amniotic basement membrane versus cryopreserved membrane in a standardized clinical setting.
Ultimately, adoption into standard corneal and refractive practice should be driven by the convergence of what we are seeing in real-world clinical experience and contemporary, peer-reviewed comparative evidence.
