An advisory panel to the US Food and Drug Administration (FDA) has voted to recommend approval of Staar Surgical's premarket approval application for the Visian Toric Implantable Collamer Lens (TICL), which would be the first device in the United States intended to correct or reduce moderate to high myopic astigmatism.
The recommendation from the Ophthalmics Devices Panel of the Medical Devices advisory committee comes despite panel members' expressed concerns about protocol deviations during a clinical trial and missing information.
Five panelists voted yes on the question of whether they considered the TICL safe for intended patients, with 1 voting no and 3 abstaining. Seven panelists voted yes on the question of whether they considered the TICL effective, with 1 voting no and 1 abstaining. Six panelists voted yes on whether they considered the lens' benefits to outweigh the risks, and 3 abstained.
The toric lens is manufactured from a proprietary polymer material, as is Staar's other implantable lens, the Visian Myopic ICL (MICL), which was FDA-approved in 2005 for treatment of myopia. The MICL has been implanted more than 400,000 times worldwide, and the TICL has been implanted about 110,000 times outside the United States, where it does have regulatory approval in 60 countries, according to the company. The lenses are implanted behind the iris in phakic eyes, or eyes that retain natural lenses.
One other intraocular lens, from Ophtec in Boca Raton, Florida, has been FDA-approved for myopia treatment, but if the FDA follows the ophthalmics panel's recommendations, the Visian TICL would be the first intraocular lens offered in the United States for myopic astigmatism as an alternative to incision or laser surgery in phakic eyes.
The path to approval of the TICL, however, has been laden with setbacks, including 2 warning letters, 2 major deficiency letters, a data integrity hold, and a "not approvable" decision by the FDA. An independent audit of clinical trial data found that 238 data points, of 92,000, needed to be modified, according to Staar. The company maintains that protocol deviations identified by the FDA did not substantially modify the outcomes of clinical research.
Clinical Trial Results
Staar, of Monrovia, California, conducted a nonrandomized clinical trial to test the effectiveness of the TICL lens from 2002 through 2005. The implantation surgeries involved 210 eyes from 124 patients with a mean myopia of −9.37 D and a mean astigmatism of +1.95 D and an average age of 35 years.
In the study, 147 (76.2%) of 193 eyes showed 12-month postoperative uncorrected visual acuity equal to or better than preoperative best-corrected visual acuity, according to Staar.
The company relied on its parent MICL safety profile for support of safety data for the TICL, monitoring mostly for preservation of best-corrected vision. At 12 months, 3 (1.5%) of 194 eyes lost 2 or more lines of best spectacle-corrected visual acuity, and no eyes had worse than 20/40 vision best-corrected.
Panel members complained, however, about the deviations from protocol and a lack of data on aspects of the study, including information on how measurements were conducted for the implants, the surgical abilities required of clinicians to do the implants, how much the implants could rotate after surgery, and possible misalignments.
They also expressed concern about endothelial cell loss, which was detected in a postmarketing study of MICL patients but was not monitored during the TICL study. Monitoring was not required by protocol.
They heard, however, from 5 practicing ophthalmologists, during the public hearing portion of the meeting, who strongly advised approval of the application, in addition to the parent of a potential patient. Two others advised against approval during the public hearing.
The testimony led panel member Andrew J. W. Huang, MD, MPH, from Washington University School of Medicine in St. Louis, Missouri, to say he was underwhelmed by Staar's data presented and overwhelmed by the statements from the ophthalmologists.
Some panel members also complained about the fact that Staar did not submit for FDA review results of a sensitivity analysis it conducted to assess the effect of protocol violations on the outcomes of clinical research. Staar representatives said the analysis was only done recently and showed that the deviations did not substantially affect the outcomes.
Panel members pointed out, however, that the analysis could have been presented to the FDA as late as the week before the hearing, which also had been postponed from a month earlier because of bad weather.
The advisory committee members have disclosed no relevant financial interests.
Medscape Medical News © 2014 WebMD, LLC
Send comments and news tips to firstname.lastname@example.org.
Cite this: FDA Panel Recommends Intraocular Lens for Astigmatism - Medscape - Mar 17, 2014.