Main Uses of Amvisc Plus

Amvisc Plus is a sterile, non-pyrogenic solution of highly purified sodium hyaluronate. It is primarily used as a surgical aid in ophthalmic procedures involving the anterior and posterior segments of the eye. Its physical properties make it particularly useful in surgeries where maintaining the integrity of the ocular spaces is necessary.

Common procedures where this solution is utilized include:

• Cataract surgery: Assisting in the extraction of the lens and the implantation of an intraocular lens (IOL).
• Corneal transplant surgery: Helping to protect the corneal endothelium and maintain the shape of the eye during the graft procedure.
• Glaucoma filtering surgery: Aiding in the creation of drainage pathways.
• Retinal attachment surgery: Assisting in the repositioning of the retina.

Benefits in Ophthalmic Surgery

As a viscoelastic agent, Amvisc Plus provides several functional benefits during delicate surgical maneuvers:

Space Maintenance

The high viscosity of the solution allows it to create and maintain a deep anterior chamber. This provides the surgeon with a clear, stable field of view and sufficient room to manipulate surgical instruments safely.

Tissue Protection

One of the primary roles of the solution is to coat and protect sensitive internal ocular tissues. It acts as a mechanical buffer for the corneal endothelial cells, which are susceptible to damage from surgical instruments or contact with an intraocular lens during implantation.

Transparency and Visualization

The optical clarity of the sodium hyaluronate ensures that the surgeon has an unobstructed view of the anatomy throughout the procedure. Because it is a cohesive substance, it remains in place during many stages of the surgery but can be efficiently removed when the procedure is complete.

Amvisc Plus is an ophthalmic viscosurgical device (OVD) containing sodium hyaluronate that is used as a temporary surgical aid during various procedures on the eye's anterior and posterior segments.

Who Can Use Amvisc Plus

This viscoelastic agent is typically used in adult patients undergoing eye surgery where the temporary maintenance of space, tissue protection, and lubrication are necessary. These procedures commonly include:

• Cataract extraction and intraocular lens (IOL) implantation
• Corneal transplantation (keratoplasty)
• Glaucoma filtering surgery
• Surgical procedures to reattach the retina

Who Cannot Use Amvisc Plus

Currently, there are no absolute contraindications to the use of Amvisc Plus when used specifically as a surgical aid in ophthalmic procedures. However, the use of Amvisc Plus, or any similar sodium hyaluronate product, is generally not recommended for individuals with a known hypersensitivity or allergy to any of its components. Additionally, since the product is derived from a biological source, the physician should be aware of the possible effects of using any biological material.

Amvisc Plus Interactions with other medicines and products

The official interaction profile for Amvisc Plus is primarily defined by a critical chemical incompatibility due to its role as a localized Ophthalmic Viscosurgical Device (OVD). The lack of systemic absorption means traditional drug-drug interactions are not documented.

Procedural and Substance Incompatibility

Interaction Type	Interacting Substance	Official Constraint
Chemical Incompatibility	Disinfectants containing Quaternary Ammonium Salts (e.g., benzalkonium chloride)	Prohibited from concurrent procedural contact

The active component, Sodium Hyaluronate, is susceptible to a chemical reaction upon contact with substances containing Quaternary Ammonium Salts, such as those used in certain preoperative washes or instrument preparation. This reaction causes the active substance to precipitate, which immediately compromises the physical integrity and viscoelastic properties essential for the device’s function. Official regulatory documentation mandates the strict exclusion of all such disinfecting agents from the surgical field to maintain the product’s integrity and prevent failure.

Absence of Systemic Drug Interactions

Due to its localized administration directly into the eye, Amvisc Plus is not associated with conventional drug-drug interactions. Official regulatory labeling confirms the absence of documented pharmacokinetic (metabolic enzyme-mediated) and pharmacodynamic interactions with orally or intravenously co-administered systemic medicinal products. Furthermore, no specific interaction cautions related to food, alcohol, or specific patient populations (e.g., hepatic or renal impairment) are noted in the product labeling.

The biomechanical mechanism of action of Amvisc Plus relies on the viscoelasticity of the high molecular weight Sodium Hyaluronate biopolymer, rather than traditional molecular targets like receptors or enzymes. This mechanism is defined by two primary domains.

Viscoelastic Structural Stabilization centers on the material's ability to provide strong resistance to shear and deformation. By physically interacting with the anterior chamber, the material contributes to maintaining the spatial relationship of the internal volume, a physiological change that preserves the structural configuration required for the procedure.

Biomechanical Cellular Interaction involves the material acting as a physical sheathing or barrier that primarily targets the corneal endothelium. This mechanism establishes a physical separation of instruments from delicate cell layers, resulting in the maintenance of endothelial cell count against mechanical trauma by dampening friction and limiting contact-induced stress. The mechanism of space maintenance and barrier formation is transient, lasting only as long as the material remains structurally intact and physically present within the eye.

How to Use Amvisc Plus

Amvisc Plus is categorized as an Ophthalmic Viscosurgical Device (OVD), a specialized surgical aid, and its use is strictly confined to the operating room during intraocular procedures. Because it is a supportive device and not a medication with systemic action, its administration follows procedure-based protocols rather than conventional pharmaceutical dosing schedules.

Official Administration Guidelines

Instruction Category	Official Requirement
Route of Administration	Intraocular injection (direct application into the anterior and/or posterior segment of the eye).
Dosing Principle	No fixed dose. The required volume of 1.6% Sodium Hyaluronate solution is determined by the surgeon based on the needs of the specific operation, such as cataract extraction or corneal transplantation.
Frequency and Schedule	Single-use during one surgical procedure. The surgeon may re-inject additional material during the operation as necessary to maintain space.

Procedural Instructions

All use must occur under aseptic surgical conditions. The product is supplied in a sterile, single-use syringe that requires the attachment of a sterile cannula prior to injection. The solution may be applied directly to the intraocular lens (IOL) before its insertion.

A critical instruction for use is the mandate for removal. The solution must be removed from the eye (specifically the anterior chamber) at the conclusion of the surgical procedure. Furthermore, the device must be protected from freezing and stored under refrigerated conditions between 2 C and 8 C prior to use.

Amvisc Plus: Recent Clinical Evidence

---

Evidence for use in Cataract Extraction and Intraocular Lens Implantation

Amvisc Plus was studied for its use as a temporary aid during eye surgery, specifically in procedures to remove a cataract and place a new intraocular lens (IOL). Research explored how this product is applied during surgery to help create and maintain space inside the eye, which was a focus of the research. Findings indicate that studies explored the product's role in the management of movement and stress on delicate eye structures, such as the cornea's inner layer, during the surgical steps. Results apply only to the populations studied, and long-term effects are not fully established.

---

Evidence for use in Corneal Transplantation Surgery

Research has explored the role of Amvisc Plus in procedures to replace a damaged or diseased cornea, known as corneal transplantation surgery. Amvisc Plus was evaluated in studies examining its application for stabilizing the corneal donor tissue before it is sewn into the patient's eye. Evidence describes patterns related to the product's physical characteristics during the placement and securing of the new corneal tissue, as observed in studies. However, comparative evidence is lacking regarding direct comparison to other similar products.

---

Long-term Studies and Follow-up

Research focusing specifically on tracking patients who received Amvisc Plus over extended time periods following their eye surgery is limited. The available evidence primarily describes short-term changes and immediate post-operative outcomes. There is limited information for long-term outcomes, meaning that the full picture of how patients fare many years after the surgery using Amvisc Plus is not fully established, and research is ongoing.

---

What is Still Uncertain About Amvisc Plus

Important evidence gaps remain. The primary limitation is the lack of comparative evidence; many studies do not directly compare Amvisc Plus to other products used in the same surgeries. Furthermore, long-term effects are not fully established, and in certain areas, findings were mixed, requiring further investigation to understand the different reported experiences across research centers. Evidence highlights what is known—and what is still uncertain.

Key Studies & References Study Details | NCT00763360 | To Compare the Ability of DiscoVisc® OVD to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery.

Common questions about Amvisc Plus (FAQ)

Q: What is Amvisc Plus used for?

Amvisc Plus (sodium hyaluronate) is a sterile, viscoelastic solution used during certain eye surgeries, such as catar extraction and intraocular lens (IOL) implantation. It helps maintain the depth and integrity of the surgical space in the anterior segment of the eye, protecting the delicate ocular tissues like the cornea and retina during the procedure.

---

Q: How is Amvisc Plus administered?

Amvisc Plus is administered directly into the anterior chamber of the eye by the ophthalmic surgeon during the surgical procedure. It is delivered through a small, sterile cannula or syringe and is designed for single-use application in the operating room. It is not a medication for at-home use.

---

Q: What is the main ingredient in Amvisc Plus?

The main active ingredient in Amvisc Plus is sodium hyaluronate, a highly purified, non-inflammatory, high-molecular-weight fraction of hyaluronic acid. Hyaluronic acid is a naturally occurring substance found in high concentrations in the vitreous and aqueous humor of the eye and is known for its viscoelastic and protective properties.

---

Q: What are the common side effects of Amvisc Plus?

Because Amvisc Plus is a medical device used during surgery, potential side effects are typically related to the surgical procedure itself or the presence of the viscoelastic material post-operatively. The most commonly reported side effects include a temporary, sometimes significant, increase in intraocular pressure (IOP). This pressure increase usually resolves on its own or with appropriate management by the eye care professional. Other potential side effects are rare and may include temporary corneal edema or inflammation.

---

Q: How long does Amvisc Plus stay in the eye after surgery?

Amvisc Plus is designed to be gradually removed by the surgeon at the end of the procedure or is naturally cleared from the eye's anterior chamber over the following days through the eye's normal fluid drainage pathways. Any transient increase in intraocular pressure is typically managed in the immediate post-operative period.

---

Q: Is Amvisc Plus the same as artificial tears or eye drops?

No, Amvisc Plus is distinctly different from artificial tears or standard eye drops. It is a highly concentrated, viscous solution used only during surgery by a qualified surgeon to protect and manipulate tissue. It is not intended for the treatment of dry eyes or for routine daily use.

How to Store and Dispose of Amvisc Plus

Amvisc Plus, an Ophthalmic Viscosurgical Device (OVD), requires specific storage and handling to maintain its sterility and efficacy before use in a clinical setting.

---

Storage Conditions

Amvisc Plus must be kept under refrigerated storage, maintained strictly between 2 C and 8 C (36 F to 46 F). It is essential to protect the product from freezing to prevent damage to the solution. The device is for single use only and must not be used if the sterile barrier is compromised or if the solution is not clear.

Prior to surgery, the refrigerated syringe should be allowed to reach room temperature.

---

Disposal and Handling

As a sterile surgical aid, disposal is primarily procedural. The product must be removed from the eye's anterior chamber at the conclusion of the surgical procedure. Unused product and packaging, including the single-use cannula, must be disposed of according to standard institutional medical waste protocols and must not be saved or reused.