Eyeworld

3 EW NEWS & OPINION June 2015 experience of many of the society's members, demonstrate the safety and efficacy of CXL. EW I n late February, a joint panel of the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthal- mic Devices Panel voted to recommend approval of Avedro's (Waltham, Mass.) drug-device com- bination of riboflavin ophthalmic solution and UVA light for cross- linking for both progressive kerato- conus and corneal ectasia following refractive surgery. However, since then, the FDA has sent a complete response letter to Avedro on its riboflavin ophthal- mic solution/KXL System for corneal crosslinking (CXL). The FDA identi- fied "a small number of areas of the application concerning the device that require additional information, none of which pertain to the clinical study safety or efficacy data present- ed in the New Drug Application," Avedro officials stated in a press release. Avedro officials think the company can provide this informa- tion, and at the 2015 ASCRS•ASOA Symposium & Congress, Avedro's CEO, David Muller, said that Avedro intends to bring it through to the finish. In late February, Avedro received a vote for approval from the Derma- tologic and Ophthalmic Drugs Ad- visory Committee and Ophthalmic Devices Panel of the Medical Devices Advisory Committee. The February panel voted on the question, "Has substantial evidence of efficacy and safety been demonstrated for the drug-device combination of Photrexa Viscous and Photrexa (riboflavin ophthalmic solution) and the KXL System (UVA light) to support approval?" twice, once regarding progressive kerato- conus and once regarding corneal ectasia following refractive surgery. Results for the progressive kerato- conus vote were 10 yes, 4 no, and 1 abstained. Results for the corneal ectasia following refractive surgery vote were 6 yes, 4 no, 4 abstained, and 1 was not present. The panel heard testimony from both the sponsor and the FDA before moving on to public testimony. Concerns were expressed from the panel mem- bers regarding the study protocol and data. However, in the end the panel members recognized the med- ical need for this procedure to be available to patients in the U.S. Thomas John, MD, Tinley Park, Ill., spoke on behalf of ASCRS as a member of the ASCRS Cornea Clin- ical Committee. ASCRS' testimony supported the approval of corneal collagen crosslinking (CXL) for the treatment of ectatic corneal disease. Dr. John's testimony noted that the peer-reviewed literature, including uncontrolled observational trials and well-conducted prospective clinical trials, as well as the personal Avedro continues to seek FDA approval of crosslinking by EyeWorld Staff Advancing CATARACT SURGERY LenSx ® LASER ® © 2015 Novartis 2/15 CRS15003JAD-A DUOVISC ® OVD BRIEF STATEMENT DESCRIPTION: DUOVISC ® Viscoelastic System is designed to give two Viscoelastic materials with different physico-chemical properties that can be used differently and/or sequentially to perform specific tasks during a cataract procedure. DUOVISC ® Viscoelastic System consists of VISCOAT ® Ophthalmic Viscosurgical Device and PROVISC ® Ophthalmic Viscosurgical Device. CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician. DESCRIPTION: VISCOAT ® (Sodium Chondroitin Sulfate – Sodium Hyaluronate) Ophthalmic Viscosurgical Device INDICATIONS: VISCOAT ® OVD is indicated for use as an ophthalmic surgical aid in anterior segment procedures including cataract extraction and intraocular lens (IOL) implantation. VISCOAT ® OVD maintains a deep anterior chamber during anterior segment surgeries, enhances visualization during the surgical procedure, and protects the corneal endothelium and other ocular tissues. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery. WARNINGS: Failure to follow assembly instructions or use of an alternate cannula may result in cannula detachment and potential patient injury. PRECAUTIONS: Precautions are limited to those normally associated with the surgical procedure being performed. Although sodium hyaluronate and sodium chondroitin sulfate are highly purified biological polymers, the physician should be aware of the potential allergic risks inherent in the use of any biological material. ADVERSE REACTIONS: VISCOAT ® OVD has been extremely well tolerated in human and animal studies. A transient rise in intraocular pressure in the early postoperative period may be expected due to the presence of sodium hyaluronate, which has been shown to effect such a rise. It is therefore recommended that VISCOAT ® OVD be removed from the anterior chamber by thorough irrigation and/or aspiration at the end of surgery to minimize postoperative IOP increases. Do not overfill anterior chamber. ATTENTION: Please refer to the directions for use for a complete listing of indications, warnings and precautions. DESCRIPTION: PROVISC ® (Sodium Hyaluronate) Ophthalmic Viscosurgical Device INDICATIONS: PROVISC ® OVD is indicated for use as an ophthalmic surgical aid in the anterior segment during cataract extraction and intraocular lens (IOL) implantation. Ophthalmic viscoelastics serve to maintain a deep anterior chamber during anterior segment surgery allowing reduced trauma to the corneal endothelium and surrounding ocular tissues. They help push back the vitreous face and prevent formation of a flat chamber during surgery. PRECAUTIONS: Postoperative increases in intraocular pressure have been reported with sodium hyaluronate products. The IOP should be carefully monitored and appropriate therapy instituted if significant increases should occur. It is recommended that PROVISC ® OVD be removed by irrigation and/or aspiration at the close of surgery. Do not overfill anterior chamber. Although sodium hyaluronate is a highly purified biological polymer, the physician should be aware of the potential allergic risks inherent in the use of any biological material; care should be used in patients with hypersensitivity to any components in this material. Cannula assembly instructions should be followed to prevent patient injury. ADVERSE REACTIONS: Postoperative inflammatory reactions such as hypopyon and iritis have been reported with the use of ophthalmic viscoelastics, as well as incidents of corneal edema, corneal decompensation, and a transient rise in intraocular pressure. It is therefore recommended that PROVISC ® OVD be removed from the anterior chamber by thorough irrigation and/or aspiration at the end of surgery to minimize postoperative IOP increases. Do not overfill anterior chamber. ATTENTION: Please refer to the directions for use for a complete listing of indications, warnings and precautions. ACRYSOF ® IQ TORIC INTRAOCULAR LENSES IMPORTANT PRODUCT INFORMATION CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. INDICATIONS: The AcrySof ® IQ Toric posterior chamber intraocular lenses are intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision. WARNINGS/PRECAUTIONS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Toric IOLs should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary lens repositioning should occur as early as possible prior to lens encapsulation. All viscoelastics should be removed from both the anterior and posterior sides of the lens; residual viscoelastics may allow the lens to rotate. Optical theory suggests that high astigmatic patients (i.e., > 2.5 D) may experience spatial distortions. Possible toric IOL related factors may include residual cylindrical error or axis misalignments. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof ® IQ Toric Cylinder Power IOLs. Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof ® Natural IOL and normal color vision. The effect on vision of the AcrySof ® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS ® or BSS PLUS ® Sterile Intraocular Irrigating Solutions. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions.

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