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Ophthalmic Devices Panel Meeting Summary for November 30, 2001

FDA PRESENTATION

Dr. Bernard Statland, Director, Office of Device Evaluation presented awards of appreciation for distinguished service to three voting members whose terms had been completed: Dr. Joel Sugar, Panel Chair, and Drs. Janice M. Jurkus and Jose S. Pulido.

DIVISION UPDATES

A. Ralph Rosenthal, M.D. - Director
Dr. Rosenthal announced the appointment of Dr. Eric Mann as Chief of the Ear, Nose and Throat Devices Branch

BRANCH UPDATES

VITREORETINAL AND EXTRAOCULAR DEVICES BRANCH
James F. Saviola, O.D. - Chief

Ciba Focus® NIGHT & DAY™(lotrafilcon A) reviewed at the July panel meeting was approved 010019 October 11, 2001

  • This soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters of astigmatism.
  • Focus® NIGHT & DAY™ TORIC
  • Focus® NIGHT & DAY™ PROGRESSIVES

The lenses may be prescribed for daily wear or extended wear for up to 30 nights of continuous wear, with removal for disposal, or cleaning and disinfection prior to reinsertion, as recommended by the eye care professional.

A precaution statement included in the labeling states:
At the extremes of the power range (above +10.00 or -15.00) oxygen transmissibility is slightly below the established threshold level required to prevent overnight corneal edema .1


1 Investigative Ophthalmology and Visual Science, October 1984;Vo l25, pp.1161-1167

In the Clinical study results section: "Other Important Study Results" are

  • Fourteen (42.4%) Focus NIGHT & DAY subjects experiencing infiltrates did so in the first month of extended wear compared to 5 (23.8%) of the Control subjects.
  • For Focus NIGHT & DAY subjects experiencing more than one endpoint, 70% (7/10) experienced the endpoint in the first month.
  • For both groups, if a subject experienced an infiltrate event in one eye the risk of a second event in the same or fellow eye was 6 times more likely as compared to having a first event.

B&L BAUSCH & LOMB® PureVision™ (balafilcon A) P980006/S4 approved November 20, 2001

The BAUSCH & LOMB® PureVision™ (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional.

The lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from

+8.00D to -20.00D when prescribed for up to 30 days of extended wear and from
+20.00D to -20.00D for daily wear or extended wear up to 7 days.

A precaution statement included in the labeling states:

The oxygen transmissibility is below the established threshold required to prevent overnight corneal edema for the extremes of the power range, above +3.00D and -5.00D2. In the U.S. clinical study, the rate of infiltrative keratitis was found to be higher with higher lens powers (see Clinical Study section of this package insert).

Although this PMA supplement was the second-of-a kind, it was originally scheduled for discussion before the Ophthalmic Devices Panel on September 21, 2001 to discuss the need for a post market study and to provide the Panel the opportunity to review clinical data from a contralateral eye clinical study. Two primary Panel reviewers had completed their reviews in preparation for the meeting.

Due to the tragic events on September 11, 2001, the September 21, 2001 Panel meeting was cancelled. During subsequent discussion, it was decided that primary clinical issues in the PMA substantially duplicated information previously reviewed by this panel. Additional homework assignments from two additional Panel members were obtained to corroborate the recommendations of the two primary reviewers in lieu of a full Panel discussion. The four advisory panel reviewers recommended that P980006/S004 for the PureVision™ Visibility Tinted Contact Lens for extended wear from 1 to 30 days between removals be approved, subject to a post approval study to assess the long term rates of microbial keratitis and associated loss of vision. Therefore, in accordance with the provisions of section 515(c)(2) of the act as amended by the Safe Medical Devices Act of 1990, this PMA was not referred to the full Ophthalmic Devices Panel, for review at an advisory panel meeting.


2Holden BA, Mertz GW. Critical Oxygen Levels to Avoid Corneal Edema for Daily and Extended Wear Contact Lenses. Invest Ophthalmol Vis Sci 25:1162, 1984.

As to our plans to better communicate the risks to both patients and practitioners, we have placed a variety of approval restrictions on these two extended wear lenses:

  • Advertising. Similar to drug advertisements, print ads for the new extended wear lenses must include accompanying information to describe the indications, contraindications, warnings and precautions. The package inserts must contain this information as well. The FDA also has developed a consumer information leaflet in a question-and-answer format (similar to information available for some prescription drugs).
  • Labeling. Practitioners will receive additional information in the professional labeling. The package inserts will contain a clinical study results section data that describes the study and provides information on the demographics and the primary safety and efficacy outcome measures. This will provide a quick reference to better understand the details of the pre-approval study. A brief description of the study and outcomes will also appear in the patient information booklet.
  • Post-approval clinical studies. As a condition of marketing approval, each manufacturer must conduct a post-market study to characterize the risk of microbial keratitis and subsequent loss of best-corrected visual acuity in the general population.

Both the Ciba and B&L studies will involve about 100 sentinel monitoring sites. These prospective, active monitoring studies are designed to provide data on 4500-5000 patient years of subjects wearing their one-month lenses during a one-year period. The protocols call for monitoring every six months for one year, without the detailed evaluation of all the parameters usually measured in a pre-approval study.

While the scope of these post-approval studies falls short of the 20,000 subjects it would take to do a statistically rigorous clinical study, they will still provide an early indication for risks in the real world setting and help to answer the question of long-term safety in the general population.

These labeling initiatives provide a better opportunity for practitioners and patients to make a wearing schedule decision based on an individual patient's response to lens wear and their acceptable level of risk.


DIAGNOSTIC AND SURGICAL DEVICES BRANCH
Everette T. Beers, Ph.D. - Chief

PMA Approvals:

  • P930016/S14 -- VISX: LASIK Mixed Astigmatism
    (<= 6.0 D in the spectacle plane)
  • P980008/S5 -- LaserSight: LASIK Myopic Astigmatism
    (-0.5 to < -6.00 D SE and up to <= 4.50 D cylinder)


PMA PRESENTATION

PMA P010018 - REFRACTEC, Inc.

Viewpoint™ Conductive Keratoplasty (CK) System

Indication for Use: for the treatment of hyperopia

Panel Recommendation by vote: Approvable with conditions (9 to 1)

Conditions of Approval

1. The indications for use statement should be revised as follows:

Conductive keratoplasty treatment is for the temporary reduction of spherical hyperopia in the range of:

+0.75 to +3.25 Diopters (D) of cycloplegic spherical hyperopia
-0.75 D or less of refractive astigmatism
+0.75 to +3.00 D cycloplegic spherical equivalent

In patients with <= 0.50 D difference between preoperative manifest and cycloplegic refractions in patients 40 years of age or older

2. The labeling should be revised to as follows:

Include the best spectacle corrected visual acuity (BSCVA) >= 2 lines data at each exam interval

Include specific subjective symptom data such as glare, halos, double vision, fluctuation of vision, variation in vision, and night driving problems

Include data on the induction of astigmatism

Include data on the loss of uncorrected visual acuity with induced astigmatism
Include predictability data at +/- 0.5D, +/- 1.0 D, and +/- 2.0 D of intended correction

Include the statement or data that the postoperative refractions suggest poor predictability of the procedure.

Include a statement or data that show the decreasing effectiveness of the procedure as the range of preoperative hyperopia increases

Include a prominent statement that the available data shows the procedure to be refractivity unstable up to 12 months. State that data beyond 12 months is not available.

Include statement regarding the 1 in 10 rate of no or slight improvement in quality of vision and an approximate 1 in 10 rate of dissatisfaction.

Include statement regarding the lack of re-treatment data, resulting in an unknown suitability for future refractive procedures.

Add to the Contraindications Sections - implantable or electrical stimulating devices such as pacemaker, autoimplantable cardiodefibrillator (AICD),cochlear implant

State that the effect in patients with narrow anterior chamber angles is unknown

State that the patients should expect, on average, an initial overcorrection which may require spectacles, followed by the expected correction at approximately 6-9 months with a drift toward undercorrection over time.

The description of the procedure should remove the statement on "gentle warming" and include a description of the placement of heated needles in the eye from 8-32 times.

3. The clinical study should be carried out to 24 months and data submitted to the FDA for review as a post market study.


CLOSING ANNOUNCEMENT

The next Panel meeting will be January 17-18, 2002


Contact: Sara M. Thornton, Executive Secretary
(301) 594-2053, ext.127; e-mail smt@cdrh.fda.gov

 


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or
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(301) 827-6500 (voice) (301) 443-1726 (fax)

EXECUTIVE SUMMARY MAY BE PURCHASED FROM: (Written Request Only)
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice) (301) 443-1726 (fax)

CDRH Advisory Committe Database