WHAT’S NEW IN GLAUCOMA
The FDA granted 510(k) clearance for BELKIN Vision’s Eagle glaucoma laser device. The device is a Q-switched, 532 nm-wavelength, frequency-doubled Nd:YAG laser that is intended for use in performing selective laser trabeculoplasty. The laser energy is delivered in a non-contact procedure directly through the limbus to the trabecular meshwork without the need for the use of a gonioscopy lens.
The FDA approved Glaukos Corp.’s new drug application for a single administration per eye of iDose TR 75 mcg, a prostaglandin analog indicated for the reduction of IOP in patients with ocular hypertension or open-angle glaucoma. iDose TR is a long-duration, intracameral procedural pharmaceutical therapy designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye.
Iridex Corp. announced the US launch of its next-generation platform Iridex 532 and Iridex 577 Lasers. Both lasers harness multiple treatment modes including continuous-wave and Iridex’s patented MicroPulse Technology and a touchscreen interface providing a wide range of clinical control options and features to optimize the treatment of retinal disorders and glaucoma. The lasers feature comprehensive treatment reports for detailed reports of treatment parameters for every procedure.
Thea Pharma announced the launch of IYUZEH (latanoprost ophthalmic solution) 0.005% in the US market. IYUZEH is the first preservative-free latanoprost for patients with primary open-angle glaucoma and ocular hypertension in the United States. It is available through authorized distributors and the following wholesalers and order numbers: ABC (10282592), ANDA (603442), Cardinal (5865035), McKesson (2849651) and NDC (82584-003-30).
Topcon Healthcare introduced the TEMPO perimeter, which features a novel binocular approach that makes visual field testing fast and fluid for patients. TEMPO can function in ambient light and is designed to reduce fatigue for patients and operators. The perimeter’s binocular feature can test the right and left eyes separately and randomly present the test object to either eye in a nonocclusion manner without the examinee being aware of which eye is being tested.
IN THE NEWS
The FDA approved Bausch + Lomb’s TENEO Excimer Laser Platform for LASIK vision correction surgery for myopia and myopic astigmatism. The advanced eye-tracker operates at 1,740 Hz, more than three times the speed of the laser’s repetition. The company says this helps to ensure the laser ablation pattern is not negatively impacted by a patient’s eye movement and to achieve outstanding postoperative outcomes.
The FDA approved ZEISS Medical Technology’s VISUMAX 800 with SMILE pro software for surgically treating nearsightedness, with or without astigmatism. The femtosecond laser enables fast treatment, creating the lenticule in less than 10 seconds due to a pulse repetition rate of 2 MHz. The laser has a small footprint and is compatible with a variety of patient beds.
NIDEK Inc. announced the commercial launch of the Mirante Scanning Laser Ophthalmoscope for the US market. The multimodal fundus imaging platform combines high-definition scanning laser ophthalmoscopy and OCT with ultra-wide-field imaging. The multimodal platform captures high-quality color images, fluorescein angiography, indocyanine green angiography, fundus autofluorescence, Retro mode images and OCT.
Harrow’s VEVYE (cyclosporine ophthalmic solution) 0.1%, a patented, nonpreserved, twice-daily dosed prescription drug based on a “waterfree” semifluorinated alkane eyedrop technology, is now available in the United States. Dispensed in a 10 µL drop, VEVYE is the first cyclosporine-based product indicated for treating dry eye disease (DED).
Alcon reported positive results from the two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512, a product candidate for the treatment of the signs and symptoms of DED. In both trials, the primary endpoint of the proportion of subjects with at least a 10-mm increase in unanesthetized Schirmer’s score achieved statistical significance at Day 14 [p<0.0001].
The AAO warned against two eye color-changing surgeries that are trending on social media: iris implant surgery and keratopigmentation, a laser surgery (also referred to as eye tattooing) that inserts pigment into the cornea. The AAO states that both of these surgeries carry serious risks for vision loss and complications and should be fully disclosed to patients.
