Description:    AMVISC® PLUS is a sterile nonpyrogenic solution of sodium hyaluronate.

AMVISC® PLUS contains 16 mg/mL of sodium hyaluronate dissolved in a physiological sodium chloride phosphate buffer solution (pH 6.8 - 7.6). In the limit of zero shear rate (1), the viscosity is 132,000 cP (132 Pa s) at 25°C and the osmolality is approximately 340 milliosmoles.

Characteristics:    Sodium hyaluronate is a high molecular weight polysaccharide composed of sodium glucuronate and N-acetylglucosamine. Sodium hyaluronate is ubiquitously distributed throughout the tissues of the body and is present in high concentrations in such tissues as vitreous humor, synovial fluid, umbilical cord and the dermis of rooster combs. Sodium hyaluronate functions as a tissue lubricant (1,2) and it is thought to play an important role in modulating the interactions between adjacent tissues. It can also act as a viscoelastic support maintaining a separation between tissues. Sodium hyaluronate prepared from different materials may have different molecular weights but is thought to have the same chemical structure. Sodium hyaluronate is also elaborated by certain bacteria as a protective substance. Those bacteria may be cultured by fermentation process to yield sodium hyaluronate. The sodium hyaluronate in AMVISC® PLUS is prepared from the dermis of rooster combs (2). It has a molecular weight greater than 1,000,000, is reported to be nonantigenic (3,4), does not cause foreign body reactions, is nonpyrogenic and is well tolerated in human eyes (5). AMVISC® PLUS does not interfere with normal wound healing processes.

Indications:    AMVISC® PLUS is indicated for use as a surgical aid in ophthalmic anterior (6) and posterior (5) segment procedures including · extraction of a cataract · implantation of an intraocular lens (IOL) · corneal transplantation surgery · glaucoma filtering surgery · surgical procedures to reattach the retina.

Because of its lubricating and viscoelastic properties, transparency and ability to protect corneal endothelial cells (7), AMVISC® PLUS helps maintain anterior chamber depth and visibility, minimizes interaction between tissues, and acts as a tamponade and vitreous substitute during retina reattachment surgery. AMVISC® PLUS also preserves tissue integrity and good visibility when used to fill the anterior and posterior segments of the eye following open sky procedures.

Contraindications:    At the present time there are no contraindications to the use of AMVISC® PLUS when used as a surgical aid in ophthalmic surgical procedures.

Applications:

1. Cataract surgery and IOL implantation--The required amount of AMVISC® PLUS is slowly infused through a needle or cannula into the anterior chamber. The protective effect of AMVISC® PLUS as an aid is optimized when the injection is performed prior to cataract extraction and insertion of the IOL and is effective for both intra- and extracapsular cataract procedures. AMVISC® PLUS may be applied to the IOL prior to insertion. Additional AMVISC® PLUS can be injected as required to facilitate surgical procedures (SEE PRECAUTIONS ).
2. Corneal transplant surgery--The corneal button is removed and the anterior chamber filled with AMVISC® PLUS until it is level with the surface of the cornea. The donor graft is then placed on top of the AMVISC® PLUS and sutured into place. Additional AMVISC® PLUS can be used as required to aid in surgical procedures (SEE PRECAUTIONS ).
3. Glaucoma filtration surgery--AMVISC® PLUS is injected through a corneal paracentesis to restore and maintain anterior chamber volume during the performance of the trabeculectomy. Additional AMVISC® PLUS can be used as required to aid in the surgical procedures (SEE PRECAUTIONS ).
4. Intraocular injection in conjunction with scleral buckling procedures for retina reattachment--After release of subretinal fluid and development of buckling by tying the mattress sutures, air is injected into the vitreous cavity and then exchanged with AMVISC® PLUS injected through a needle (22 to 30 gauge) passed via the pars plana epithelium. The volume of AMVISC® PLUS injected (2-4 mL) will vary with the volume of the subretinal fluid released and the space occupied by the buckle.

Precautions:    Those precautions normally considered during anterior segment and retina reattachment procedures are recommended.

There may be increased intraocular pressure following surgery (8) caused by preexisting glaucoma or by the surgery itself. For these reasons the following precautions should be considered.

·An excess quantity of AMVISC® PLUS should not be used. · AMVISC® PLUS should be removed from the anterior chamber at the end of surgery to prevent or minimize post-operative intraocular pressure increases (spikes). · If the postoperative intraocular pressure increases above expected values, correcting therapy should be administered. · AMVISC® PLUS is prepared from a biological source and the physician should be aware of the possible effects of using any biological materials. · Reuse of cannula should be avoided. Even after cleaning and rinsing, resterilized cannula could release particulate matter as AMVISC® PLUS is injected. It is recommended that disposable cannula be used when administering AMVISC® PLUS. · There have been isolated reports of diffuse particulates or haziness appearing after injection of AMVISC® PLUS into the eye. While such reports are infrequent and seldom associated with any effects on ocular tissues, the physician should be aware of this occurrence. If observed, the particulate matter should be removed by irrigation and/or aspiration.

Adverse Reactions:    Sodium hyaluronate is a natural component of the tissues of the body and is extremely well tolerated in human eyes. Transient postoperative inflammatory reactions were reported in clinical trials (5) and oral and topical steroid preparations were administered. AMVISC® PLUS is tested in animals to determine that each batch is essentially noninflammatory. Since sodium hyaluronate molecules are noninflammatory, any phlogistic response is considered to be caused by the surgical procedures. The best index of the degree of phlogistic response is the postoperative clarity of the vitreous cavity. As outlined above transient postoperative increase in intraocular pressure has been observed following the use of sodium hyaluronate in anterior segment surgery. On rare occasions postoperative reactions including inflammation, corneal edema and corneal decompensation have been reported. The relationship to the use of AMVISC® PLUS has not been established.

Adverse Reaction Reporting:    Adverse reactions and/or potentially sight-threatening complications that may be reasonably regarded as AMVISC® PLUS related and that were not previously expected in nature, severity or degree of incidence should be reported to Bausch & Lomb Surgical at 800-338-2020 or 909-971-5100. Outside the USA call your customer service affiliate.

How Supplied:    AMVISC® PLUS is a sterile viscoelastic preparation supplied in a disposable glass syringe delivering either 0.5 mL or 0.8 mL of sodium hyaluronate dissolved in physiological sodium chloride phosphate buffer solution. Each mL of AMVISC® PLUS contains 16 mg of sodium hyaluronate. Sodium hydroxide and/or hydrochloric acid are added to adjust pH (if necessary). AMVISC® PLUS is sterile filtered and aseptically transferred to syringes. The filled syringes are sealed and final package sterilized (R). Contents of unopened and undamaged pouches are sterile. Refrigerated AMVISC® PLUS should be allowed to reach room temperature (approximately 20 to 45 minutes, depending on volume) prior to use.

For Intraocular Use:    Store at 2-8°C. Protect from freezing.

Caution:    Federal U.S. law restricts this device to sale by or on the order of a physician.

References:

1. Arshinoff, Steve A., MD: "Dispersive and Cohesive Viscoelastic Materials in Phacoemulsification;" Ophthalmic Practice; 13:3, 1995.
2. Swann DA. Studies of Hyaluronic Acid. I. The preparation and properties of rooster comb hyaluronic acid. Biochim Biophys Acta 1968; 156:17.
3. Richter W. Non-immunogenicity of purified hyaluronic acid preparations tested by passive cutaneous anaphylaxis. Int Arch Allergy 1974; 47:211.
4. Richter, W, Ryde EM, Zetterstrom EO. Non-immunogenicity of a purified sodium hyaluronate preparation in man. Int Arch Appl Immunol 1979; 59:45.
5. Pruett RC, Schepens CL, Swann DA. Hyaluronic acid vitreous substitute. A six year clinical evaluation. Arch Ophthalmol 1979; 97:2325.
6. Pape LG, Balazs EA. The use of sodium hyaluronate (Healon®) in human anterior segment surgery. Ophthalmol 1980; 87:699.
7. Miller D, Stegmann R. Use of Na-hyaluronate in anterior segment eye surgery. AM Intra-Ocular Implant Soc J 1980; 6:13.
8. Miller D, Stegmann R. The use of Healon® in intraocular lens implantation. Int Ophthalmol Clinics 1982; 22:177.

Manufacturer:

Bausch & Lomb Incorporated

Rochester, NY 14609 U.S.A.

EU Authorised Representative: Bausch & Lomb Incorporated

Regent Park · Kingston Road

Leatherhead KT22, 7PQ UK

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© 2003 Copyright of Bausch & Lomb, Incorporated. All rights reserved.

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