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Implantable Miniature Telescope not recommended for approval

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The Food and Drug Administration’s ophthalmic devices advisory panel voted 10-3 not to recommend for approval VisionCare Ophthalmic Technology’s Implantable Miniature Telescope.

The panel found that “the data did not provide reasonable assurance that the device is safe and effective under the conditions of use prescribed, recommended, or suggested in the proposed labeling,” according to a summary of the July 14 meeting.

The Implantable Miniature Telescope (IMT) is intended for adult patients with bilateral, stable, untreatable moderate to profound central vision loss due to macular degeneration or Stargardt’s macular dystrophy.

The IMT is a micro-sized precision telescope that is implanted in one eye in an outpatient surgical procedure conducted under local anesthesia. The device provides magnification of 3.0X or 2.2X, varying by model.

The advisory committee based its decision on unresolved safety concerns, as well as uncertainty regarding device efficacy. “The panel noted that the absence of morphometric analysis of the endothelial cell density data did not allow to adequately evaluate the chronic rate of endothelial cell density loss, a major safety concern for the device, in eyes that had received the IMT. In addition, the panel noted confounding factors that may have influenced the efficacy of the device,” according to the summary.

The device’s manufacturer had conducted a prospective, multicenter trial involving 218 consecutive patients enrolled at 28 sites. The study’s primary safety endpoint was a mean loss of endothelial cell density of less than 17% at one year postoperatively. Also, no more than 10% of eyes could lose more than 2 lines of either near or distance best corrected visual acuity (BCVA) without a corresponding 2 or more gain in BCVA.

However, at 1 year follow-up, mean endothelial cell density had decreased 25.3% in IMT-implanted eyes, although 90.1% of eyes had improved at least 2 lines in either near or distance best corrected visual acuity, according to the summary.