Simbrinza is a fixed-dose combination of a carbonic anhydrase inhibitor (brinzolamide 1.0%) and an alpha 2 adrenergic receptor agonist (brimonidine tartrate 0.2%). It combines the two drugs into one multi-dose bottle, helping to reduce the medication burden for glaucoma patients. Patients are to administer one drop of Simbrinza into the affected eye(s), three times per day.
The FDA approval of Simbrinza is based on data from two pivotal Phase III clinical trials with approximately 1,300 patients. The studies evaluated the safety and efficacy of a fixed-dose combination of brinzolamide 1.0% and brimonidine 0.2%, administered three times daily, compared to separate three-times-per-day dosing of one or the other component. Both studies met their primary endpoint and demonstrated that Simbrinza is statistically superior compared to either component regarding mean IOP at month three for all time points. In both studies, Simbrinza achieved a 5 mmHg to 9 mmHg reduction from baseline to month three. Patients’ mean IOP at baseline was 22 mmHg to 36 mmHg.
In the two, three-month clinical trials, the most frequently reported adverse reactions in patients treated with Simbrinza (occurring in approximately 3 to 5 percent of patients in descending order of incidence) were blurred vision, eye irritation, dysgeusia (bad taste), dry mouth and eye allergy. Treatment discontinuation, mainly due to adverse reaction, was reported in 11 percent of Simbrinza patients. The safety profile of Simbrinza is comparable to each of the individual components. Additionally, there were no significant cardiovascular or pulmonary events found with Simbrinza in either clinical study conducted.
For more information, visit alcon.com.
Prolensa, B+L Once-Daily NSAID Approved for Post-Cataract
Bausch + Lomb announced FDA approval of its New Drug Application for Prolensa (bromfenac ophthalmic solution) 0.07 % prescription eye drop, a once-daily nonsteroidal anti-inflammatory drug for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Prolensa will be available in 1.6 ml and 3 ml bottle sizes.
The efficacy of Prolensa was evaluated in two randomized, double-masked, vehicle-controlled studies of patients undergoing cataract surgery. Each randomized patient received Prolensa or vehicle starting with one drop into the surgical eye on the day prior to and the day of surgery, and for 14 days following surgery. The primary efficacy endpoint was complete clearing of ocular inflammation (assessed by the summed ocular inflammation score, SOIS, which includes cells and flare) by day 15. The secondary efficacy endpoint was the number of subjects who were pain-free on day one after surgery.
Results from the pivotal studies demonstrated Prolensa to be superior to vehicle in the treatment of both inflammation and pain following cataract surgery. Twice as many patients as vehicle (46 percent versus 20 percent) demonstrated complete clearance of inflammation (SOIS of 0) at day 15. The difference in the average postoperative inflammation severity between the treatment and vehicle arms was statistically and clinically significant by day eight. Nearly four of five patients treated with Prolensa were pain-free at day one (78.8 percent versus 49.5 percent for vehicle; p<0.0001). Patients treated with Prolensa reported a lower incidence of foreign body sensation and photophobia and had less redness than those treated with vehicle. For information, visit bausch.com.
Oasis Debuts Diamond-Like Feather Keratome
Oasis Medical has announced the availability of the diamond-like Feather keratome. Feather utilizes proprietary manufacturing technology that produces an ultra-sharp, low-friction blade performance that rivals diamonds, the company says. It can be used multiple times, which helps to manage cost per case while maintaining compliance with Center for Medicare & Medicaid regulations.
The new Feather keratome blades are available in widths of 1.4 mm, 1.6 mm, 1.8 mm, 2.2 mm, 2.4 mm, 2.75 mm, 2.8 mm, 3 mm and 3.2 mm. For information, call 1 (800) 528-9786 or visit oasismedical.com.
Leica, B+L to Partner in Distribution
Leica Microsystems and Bausch + Lomb announced that Bausch + Lomb will distribute Leica ophthalmic surgical microscopes and accessories in select markets across Europe, the United States, India and Latin America beginning in April.
The partnership combines Leica’s innovative ophthalmic microscopes with Bausch + Lomb’s global commercial infrastructure, while expanding Bausch + Lomb’s offerings for ophthalmic surgeons. Bausch + Lomb’s current portfolio of products for cataract, refractive and retinal surgery includes intraocular lenses, equipment, instruments, procedure packs and other supplies. Under this agreement, Bausch + Lomb can now offer Leica Microsystems’ ophthalmic portfolio, which ranges from routine cataract microscopes to high-end retinal systems. Among these is the Leica M822 for cataract procedures, which combines LED and halogen lighting for a stable red reflex.
For information, visit leica-microsystems.com or bausch.com.
LEITR Reports First Use of Preloaded, Eye-Bank Cartridge for Corneal Transplant
Lions Eye Institute for Transplant & Research announced that for the first time, EndoGlide (Angiotech Pharmaceuticals) cartridges preloaded by an eye bank have been successfully used in corneal transplantation.
The EndoGlide was selected for initial endothelial keratoplasty transplant procedures using donor endothelial tissue that was pre-cut, trephined and pre-loaded into the device at LEITR in Tampa, Fla. It was then transported to the Massachusetts Eye and Ear Infirmary, where the procedures were performed by Roberto Pineda II, MD, associate professor of ophthalmology at Harvard Medical School.
To date, more than a dozen cases have been performed at Massachusetts Eye & Ear by Dr. Pineda and by Kathryn Colby, MD, PhD, associate professor of ophthalmology at Harvard Medical School. “In published literature, the EndoGlide device has already shown excellent outcomes in endothelial cell protection when loaded by surgeons,” says Dr. Pineda. “Tissue preparation and device pre-loading by eye banks simplifies the surgery and may provide increased reproducible outcomes for endothelial keratoplasty.” Last year, LEITR reported that eye banks are able to safely prepare and load corneal tissue into the EndoGlide cartridges.
In a pre-clinical study presented at the 2012 Association for Research in Vision and Ophthalmology Annual Meeting, corneal buttons pre-loaded by LEITR sustained an average of 9.07 percent endothelial cell damage, compared to 36.2 percent endothelial cell damage in control group tissue that was loaded into the insertion system on site. The difference in endothelial damage between the preloaded and control buttons was statistically significant (p=0.004).
“Eye banks have proven their ability to change industry practices for the better,” said Lewis R. Groden, MD, medical director at LEITR, associate professor of ophthalmology at the University of South Florida, and executive medical director of LasikPlus Vision Center/LCA Vision. “Pre-loading grafts into insertion cartridges prior to transport may be a compelling new innovation for endothelial keratoplasty,” he said. REVIEW