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Volume 13, Number 7
March 10, 2008
Organized Ophthalmology and Government Agencies Discuss Possibility for Study of the Dissatisfied LASIK Patient.
Visian toric lens approved in China
Sirolimus achieves positive preliminary results in Phase 1 study
Antibody fragments achieve high concentration in eye in preclinical studies
ASCRS emphasizes importance of patient consent for dilating drops

Organized Ophthalmology and Government Agencies Discuss Possibility for Study of the Dissatisfied LASIK Patient.

In a ground breaking interaction, the U.S. Food and Drug Administration (FDA), approached the American Society of Cataract and Refractive Surgery (ASCRS) in the fall of 2006 for guidance in designing a study to that would identify extremely dissatisfied post-LASIK patients, define their significant symptoms, and the impact of those symptoms on quality of life.

The call for this study was spurred by several FDA petitioners who urged a moratorium on eye surgeries that were not medically necessitated. Dean Andrew Kantis and Michael Patterson, Ph.D., petitioned the FDA to reconsider current regulations and enforcement procedures for LASIK or phakic lens-related medical devices.

Although the FDA did not see the majority of requests as meriting new investigation, on July 20, 2007, they did consent to allow the petitioners to present testimony at a special meeting of the Ophthalmic Device Panel (ODP). At this meeting panel members of the ODP will review issues related to poor outcomes from LASIK and phakic IOL devices and consider how this affects quality-of-life. The FDA has set April 24-25, 2008 for the OPD session.

Following the FDA request for guidance from ASCRS in designing a study focusing on significant symptoms and their impact on quality-of-life, the ASCRS leadership worked to form a joint task force with the American Academy of Ophthalmology (Academy) and the two government entities, the FDA and the National Eye Institute (NEI). This joint task force is intended to hammer out issues involving the feasibility and design of such a study.

“In dealing with the many aspects of these discussions and their roles in the Joint Task Force, ASCRS and AAO will rely upon the best interests of patients, scientific validity, and transparency to guide their actions,” said Richard L. Lindstrom, MD, ASCRS president and Joint Task Force Chair.

The ASCRS also launched a meta-analysis on patient reported outcomes and quality of life after LASIK. Task Force member Kerry Solomon, M.D., is directing the study, which will cull through the world’s reported literature on quality of life after LASIK with various outcomes. He is slated to report his findings at the 2008 ASCRS ASOA Annual Symposium and Congress, to be held in Chicago. The Joint Task force will also review the findings. No final decisions by the Joint Task Force regarding the need for a study or its design have as yet been made. The task force continues to explore the development of a comprehensive patient reported quality of life/outcomes survey instrument, which they intend to validate. ASCRS and AAO have determined that such a tool is necessary and will be developed regardless of the task force’s recommendations. ASCRS will also share any relevant information on dis-satisfied patients gleaned from the World Literature Review with all task force members. “A validated quality of life/patient reported outcomes, web-based study instrument will enhance the quality and comparability of many future studies worldwide, which clearly can be of value to patient and surgeon education, thus enhancing quality of care for decades to come,” Dr. Lindstrom said.

Ultimately, Joint Task Force recommendations will be put to the governing boards of the ASCRS and AAO to consider. Then, it will fall to the regulatory agencies to determine what, if any, steps need to be taken.
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Visian toric lens approved in China

The Visian Toric Implantable Collamer Lens (STAAR Surgical, Monrovia, Calif.) has been granted marketing approval by Chinese regulatory bodies, STAAR said in a news release. The company was also granted approval to market the Visian ICH, a collamer lens for the treatment of hyperopia. The Visian TICL is approved to treat myopic patients with refractive errors between –3 and –20 D and astigmatism up to 6 D. The Visian ICH lens is approved for hyperopic patients with refractive errors between +1.0 and +4 D, STAAR said.

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Sirolimus achieves positive preliminary results in Phase 1 study

Sirolimus (rapamycin, MacuSight, Union City, Calif.) has exhibited a favorable safety profile and improvements in visual acuity in the treatment of wet age-related macular degeneration (AMD) during a Phase I study, the company said in a press release. In the randomized, open-label study, Pravin U. Dugel, M.D., and colleagues assessed the “safety, tolerability and biological activity” of sirolimus when administered by either subconjunctival or intravitreal injection. The researchers found no sign of increased intraocular pressure (IOP), inflammatory response, or cataract progression related to sirolimus treatment.  In addition, the researchers found that the sirolumus-treated patients demonstrated improved visual acuity and reduced retinal thickness. Sirolimus delivered through subconjunctival injection was found to “as effective, if not more so,” than sirolimus delivered through intravitreal injection, MacuSight said in the release.

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Antibody fragments achieve high concentration in eye in preclinical studies

Preclinical studies have shown antibody fragments can be delivered to the eye via drops, with therapeutic concentrations found in both anterior and posterior chambers, said developer ESBATech (Zurich, Switzerland). The company noted the fragment treatments were found in “high concentrations” in the eye after topical delivery. Antibody fragments have emerged as a new class of therapeutics within the monoclonal antibody market, and are considered advantageous due to their smaller molecular size, the company said. Its lead compound, ESBA105, is a TNFa antagonist and is slated to go into clinical development later this year, the company said.

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ASCRS emphasizes importance of patient consent for dilating drops

Ophthalmologists should guard themselves against liability risk by warning patients of the side effects of treatments which may impair driving, such as dilating drops, said ASCRS. The statement was in response to a recent Massachusetts court ruling, which expands the liability risk for physicians who fail to warn patients about the side effects of medications. “Regardless of location, ASCRS members should protect themselves from such liability risk by warning their patients about the possible side effects of medications and other treatments that may impair a patient’s ability to drive,” ASCRS said in the release. ASCRS advised physicians to discourage patients from driving after dilation, or at a minimum, explain the risk of driving after dilation and have the patient sign a consent form; furthermore, for those patients who choose to drive in spite of this information, clinicians should provide inexpensive but effective sunglasses for purchase.

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EYEWORLD WEEK Online is edited by Stacy Majewicz and Michelle Dalton.

EyeWorld Week Online (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: David F. Chang, M.D., chief medical editor; Bonnie An Henderson, M.D., cataract editor; Edward J. Holland, M.D., cornea editor; Reay H. Brown, M.D., glaucoma editor; Kerry D. Solomon, M.D., refractive editor; and John A. Vukich, M.D., international editor

For sponsorship opportunities or membership information, contact:
ASCRS•ASOA • 4000 Legato Rd. • Suite 700 • Fairfax, VA 22033 • Phone: 703-591-2220 • Fax: 703-591-0614 • Email: ASCRS

Opinions expressed in EyeWorld Week do not necessarily reflect those of ASCRS•ASOA. Mention of products or services does not constitute an endorsement by ASCRS•ASOA.

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