This morning, February 12, the FDA released background material in advance of the upcoming Ophthalmic Devices Panel Meeting this Friday, February 14, regarding Staar Surgical’s premarket approval application for the Visian toric implantable collamer lens (TICL).
The pre-panel commentary carried a negative slant on certain aspects of the product and corresponding data. However, this is fairly common when it comes to device panels and generally speaking, we would not view the commentary as overly surprising or harsh.
One area of likely focus will be the protocol deviations within the company’s trial; there were more than 700 occurrences reported. While the headline reads damagingly, around 300 of these can be attributed to missed patient visits and missing information, which we do not believe should be material to the evaluation. In addition, there is some skepticism about the product as the lowest cylinder proposed would be lower than any intraocular lens on the domestic market; the effectiveness of a low cylinder power is difficult to demonstrate, though the company has actually implanted lower diameters (0.78D was the lowest in the study) and has robust realworld experience with TICLs already available in more than 60 markets worldwide. Finally, there was some commentary about potential study bias related primarily to a lack of a control group or masking the clinician to the results, which is likely to draw scrutiny from the panel.
The company has prepared aggressively for Friday’s panel, including contracting with a consultant that worked with Bausch & Lomb last April as it went through a similar review process (with questions of effectiveness) for its Trulign toric accommodating intraocular lens, which was then successfully approved six weeks post-panel. In addition, the company has accumulated significant amounts of clinical data on the TICL.
Vision care panels have appeared more lenient over the last year; Bausch & Lomb received a favorable recommendation despite protocol deviations (albeit a smaller number than Staar) and questions on product effectiveness. While there is not much panel overlap (only 4 out of the 18 panel members were also on the Bausch & Lomb panel), we believe it is reasonable to assume that Staar will receive a positive panel decision in a couple of days.
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