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Phase 3 trial of Nidek laser for hyperopia to expand

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The first part of a U.S. hyperopia study using the Nidek EC-5000 laser showed results “over and above” the Food and Drug Administration’s criteria for approval, the company announced earlier this month. As a result, the phase 3 laser refractive surgery study will expand to include 300 eyes.

Three-month data has already been generated for 46 of 70 eyes enrolled in the earlier portion of the trial. To date, 35 eyes (76.1%) had a mean refractive spherical equivalent within 0.5 D of target at 3 months, 42 eyes (91.3%) were within 1 D. And according to Nidek, 97.8% of eyes had uncorrected visual acuity of 20/40 or better.

Nidek is also in “detailed discussions” with the FDA to begin additional studies on the EC-5000. The system is currently approved for the reduction or elimination of myopia from –0.75 to –14 D and for moderate myopia of –1 to –8 D with refractive astigmatism ranging from –0.5 to –4 D by manifest refraction, using either LASIK or photorefractive keratectomy.