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RECENT PREMARKET APPROVALS
Bausch & Lomb has received FDA approval to market its Active Eyetracking System. The Technolas 217A excimer laser with the Active Eyetracking System calculates both the speed of tracking and overall system reaction time, using its active feedback scanner mechanism, prior to firing the laser pulse.
Bausch & Lomb has received 510(k) approval for its 25-Gauge Entry Site Alignment (ESA) device. The ESA is a key component of the Millennium TSV25 System for transconjunctival standard vitrectomy.
¤ Bausch & Lomb’s Technolas 217A Laser System received FDA approval for the treatment of expanded indications of moderate-to-high levels of myopia. The Technolas 217A Laser System now is approved for the treatment of myopia with astigmatism of up to –12 D spherical equivalent, and sphere between –7 D to –0.99 D and cylinder less than –3 D.
CIBA Vision has received FDA approval for the company’s Focus Night & Day contact lenses for extended wear for up to 30 nights of continuous wear. The lens will be offered in two base curve sizes of 8.6 mm and 8.4 mm with a 13.8-mm diameter. The power range will include +0.25 D to +6 D in 0.25-D steps, –0.25 D to –8 D in 0.25-D steps and –8.5 D to –10 D in 0.5-D steps.
LaserSight has received approval for its LaserScan LSX precision microspot scanning excimer laser system for the LASIK treatment of myopia with and without astigmatism. The approval is for a range of treatment of refractive errors up to –6 D manifest refraction spherical equivalent with or without a refractive astigmatism up to 4.5 D of cylinder. The FDA approved LaserSight’s PMA Supplement to increase the laser pulse repetition rate of the LaserScan LSX precision microspot scanning system to 200 Hz for LASIK treatment of myopia and myopic astigmatism.
Nidek was granted 510(k) clearance for the DC-3300 Diode Laser System. The Nidek DC-3300 can now be marketed and sold for uses in retinal photocoagulation and glaucoma procedures.
Refractec received FDA approval for Conductive Keratoplasty (CK). CK utilizes the controlled release of radio frequency energy, instead of a laser or scalpel, to reshape the cornea.
¤ Tomey Corporation announced the 510k clearance of the UD-1000 Ultrasound B-scan for sales in the United States.
VISX received FDA approval for Custom-CAP treatment method for customization of laser vision correction treatments for decentered ablations. The approval was granted under Humanitarian Device Exemption.
Zeiss Humphrey received marketing approval for its Optical Coherence Tomographer Model 3000, the OCT3.
AWAITING APPROVAL
Alcon Inc. and Landec Corp. Port punctum occluder: Dry eye product has completed clinical trials, and 510(k) has been filed.
CIBA Vision Corp. and QLT Inc. Visudyne: Supplemental New Drug Application was submitted for the treatment of eye diseases other than age-related macular degeneration but characterized by choroidal neovascularization.
CRS Clinical Research LASIK: The FDA accepted two applications for premarket approval of LASIK. The applications cover LASIK treatment for spherical and spherocylindrical myopia up to 14 D, with up to 6 D of astigmatism.
Hoffmann-La Roche Valganciclovir: The company submitted an NDA to the FDA for the treatment of cytomegalovirus retinitis in patients with AIDS.
Laser Corp Q-LAS 10: The company received FDA 510(k) clearance for its Q-switched YAG laser, which is integrated into the arm of the slit lamp.
Medical Development Research received FDA approval to begin phase 1 clinical trials on the Hydroflex II Advanced Series hydrophilic acrylic IOL in the United States.
Nidek EC-5000 Excimer Laser: The company submitted a PMA with the FDA Oct. 20, 2000 for its excimer laser system to treat hyperopia and hyperopia with astigmatism.
Pharmacia Corp. Xalcom: Combination glaucoma treatment has received an approvable letter from the FDA.
Pharmacia Corp. Xalatan: The NDA submitted for combination glaucoma treatment indication has received priority review status by the FDA.
VisiJet Inc. HydroKeratome: Microkeratome for LASIK was filed for approval.
RECENT APPLICATIONS
¤ The FDA accepted Alcon’s LADARWave custom wavefront-guided laser eye surgery PMA.
Allergan AGN 195795: The company has submitted an IND application to the FDA for its gene-specific adrenergic agonist for the treatment of glaucoma.
Anamed announced that the FDA has approved its IDE to begin a clinical trial with its PermaVision intracorneal lens for the correction of hyperopia up to +6 D.
Inspire Pharmaceuticals: The company has filed an IND for the drug INS37217 for treatment of retinal detachment and edema.
Nidek, Inc. has submitted a 510(k) application for the Nidek Advanced Vision Information System (NAVIS) to the FDA for evaluation of its image restoration function.
PHASE 3
Akorn Inc. Feldene (piroxicam): Topical ophthalmic NSAID for cataract surgery.
Medennium has received approval from the FDA to expand to phase 3 of the U.S. trials of its Phakic Refractive Lens for the treatment of myopia.
¤ Indicates activity within the past 30 days.