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FDA approves Pharmacia’s CeeOn Edge 911A IOL

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PEAPACK, NJ— Pharmacia (NYSE: PHA) announced April 16 that the U.S. Food and Drug Administration (FDA) has approved the CeeOn Edge 911A IOL.

Although the FDA approval did not include any indications regarding posterior capsule opacification (PCO) prevention, other clinical studies have indicated the foldable CeeOn Edge 911A exhibited optical clarity while registering a low incidence of PCO.

A one-year follow-up of 222 European patients implanted with the CeeOn Edge found that only 0.9% of patients required surgical interventions or Nd:YAG laser treatment to address post-surgical PCO.

Pharmacia says the low incidence of PCO is attributed to the squared-edge design of the CeeOn Edge optic. The square edge blocks cells from traveling to the posterior capsule area and then accumulating on the lens surface.

In a press release, Anders Härfstrand, MD, PhD, vice-president, global ophthalmology business for Pharmacia said the low PCO rate translates into fewer complications, long-term cost savings and satisfied patients. In addition, the medium refractive silicone in the lens, combined with its equi-biconvex curvature, resulted in few reports of glare, glistening or other undesirable visual effects, while providing patients with improved vision.

The U.S. registration trial for CeeOn Edge enrolled 434 patients in 15 centers in the United States. Of 320 patients who completed one-year evaluations, 97 percent achieved best corrected visual acuity (BCVA) of 20/40 or better. In addition, the subset of best-case patients achieved 99 percent of BCVA of 20/40 or better. Of 426 eyes, only 14 (3.3 percent) required surgical reintervention or Nd:YAG laser treatment. Only 18 ocular effects were reported in 426 patients.

Specifications of the CeeOn Edge 911A include the silicone material with a refractive index of 1.46 and an optic size of 6.0 mm featuring no optic rim along a full optic zone. The overall length of the IOL is 12.0 mm with a square edge design featuring a haptic angulation of 6 degrees. The haptic material is polyvinylidenefluoride and uses a Cap C design. The CeeOn has a diopter range covering +5 to 30.