BromSite, developed by InSite Vision, is the first bromfenac ophthalmic solution formulated in DuraSite, a polymer-based formulation that can be used to improve solubility, absorption, bioavailability and residence time as compared to conventional topical therapies. Sun Pharma acquired InSite Vision in November 2015 and is likely to commercialize BromSite through its newly formed, U.S.-based division, Sun Ophthalmics, in the second half of 2016. Sun Ophthalmics aims to provide eye-care practitioners products that enhance their practice patterns and treatment options and to deliver those products through its unique, concierge-level approach to customer care, the company says.
In two multicenter, randomized, placebo-controlled Phase III studies, a significantly higher proportion of BromSite-treated patients were pain-free at day one post-surgery (77 percent and 82 percent) compared to patients treated with vehicle control (48 percent and 62 percent) (p<0.001). Additionally, a significantly higher proportion of subjects administered BromSite were inflammation-free at day 15 post-cataract surgery (57 percent and 38 percent), compared to a vehicle control group (19 percent and 22 percent, p<0.001 and p=0.035).
For information, visit sunpharma.com.
Triggerfish Comes to Market
Sensimed AG announced the FDA marketing clearance of its first-of-kind product, the Sensimed Triggerfish. The Sensimed Triggerfish is a sensor-embedded contact lens- based system that Sensimed developed to improve the management of glaucoma.
Combining a fully integrated sensor and telemetry, it provides a wireless automated recording of continuous ocular dimensional changes over the course of 24 hours. This measurement parameter, while closely correlated with intraocular pressure, is a unique measure in itself, the company says. A recent study published in Ophthalmology linked this unique continuous volumetric eye measurement to glaucoma disease progression and concluded that the Sensimed Triggerfish “may be useful in detecting eyes at higher risk of glaucoma progression while receiving treatment.”1
The FDA reviewed the Sensimed Triggerfish application through the de novo process used for first-of-a-kind technologies that are not substantially equivalent to an already marketed device. The Sensimed Triggerfish was classified in the newly created category entitled Diurnal Pattern Recorder System, defined as a non-implantable, prescription device incorporating a telemetric sensor to detect changes in ocular dimension for monitoring diurnal patterns of intraocular pressure fluctuations.
The device has been approved with the following indication:
The Sensimed Triggerfish is a prescription device indicated to detect the peak patterns of variation in intraocular pressure over a maximum period of 24 hours to identify the window of time to measure intraocular pressure by conventional clinical methods. The Sensimed Triggerfish is indicated for patients 22 years of age and older.
The company’s goal for the upcoming months is not to immediately launch the product but rather to work closely with the glaucoma community to design and execute a major post-approval study to confirm the use of the Sensimed Triggerfish signal to predict the course of progression of the disease. The overall aim is to build additional clinical utility for the device and establish ocular volume change patterns as a significant stand-alone reference biomarker for use in the management and treatment of glaucoma, the company said. For information, visit sensimed.ch
1. De Moraes C. G. et al. Visual Field Change and 24-Hour IOP-Related Profile with a Contact Lens Sensor in Treated Glaucoma Patients. Ophthalmology, in press.
Smart Vision Labs, a maker of mobile autorefractors and other diagnostics, announced two additions to its product offerings. The SVOne Enterprise is the world’s first fully automated, self-guided objective refraction technology, combining the power of mobile computation, precision optics and connectivity.
The SVOne Pro is an upgraded version of the company’s core technology with an increased range of power and several features that improve usability and accuracy. Results from the voice-guided refraction examination are automatically uploaded to a secure, HIPAA-compliant cloud platform. Ideal for use in retail locations, pharmacies, hospitals, workplaces, schools and other remote settings, the SVOne Enterprise provides eye-care providers a powerful patient engagement and remote patient monitoring tool. The SVOne Pro has the same core technology as the original SVOne autorefractor, but with increased range of power and improved usability. The new device features a new open view channel so the operator can see patients’ eyes when aligning the SVOne Pro. When the pupil is detected, the SVOne Pro auto-triggers to automatically acquire wavefront data through its software. The measurement parameters of both the SVOne Enterprise and SVOne Pro have been increased to cover the vision needs of 99 percent of the population: The sphere range is -14 to +14 D, and the cylinder range is -7 to +7 D. The SVOne Enterprise and SVOne Pro are powerful enough to use in any clinical setting while portable enough to be an ideal tool in any non-clinical setting. The FDA Class 1 exempt devices weigh less than a pound each and the price point makes it accessible to the average clinician. The smartphone-based aberrometer has been shown to measure refractive error comparable with subjective refraction and an office-based autorefractor under both cycloplegic and non-cycloplegic conditions in visually normal young adults, the company reports. For information, visit smartvisionlabs.com.
PanoCam Wide-field Imaging for Newborn Infants
Visunex Medical Systems announced the FDA clearance of its PanoCam Pro Wide-field Imaging System for the imaging of all newborn infants.
PanoCam Pro is a wireless imaging system that fills an unmet need in the imaging of all newborn babies that may help detect external, anterior and posterior segment vision disorders that may have long-term effects on the vision of millions of children around the world each year.
Early research done in Asia, Brazil and the United States suggests that one in 70 children born may have some form of vision disorder, the company says.
Newborn vision screening is already a clinically valued and established method for evaluating retinopathy of prematurity and retinoblastoma, which are life-threatening and can lead to newborn vision loss. The PanoCam Pro allows for complete visualization of the surface and sub-surface retinal pathologies unlike any other device on the market.
Newborn eye testing is most commonly performed when a child enters kindergarten at the age of 5 or 6 years. The company says that many clinicians believe the vision screening of newborns with the PanoCam Pro may help shed additional light on the significance of disorders such as retinal hemorrhages, which may be a precursor to amblyopia. Other vision disorders may be detected, and if detected early, can give caregivers the opportunity to intervene and provide the treatment to thwart vision loss and improve care pathways and newborn vision into adulthood.
Darius M. Moshfeghi, MD, director of pediatric vitreoretinal surgery and ophthalmologic telemedicine at Stanford University, said, “The advent of technology that helps assess the structures and function of the retina, combined with software solutions that elevate patient care, is a huge step forward.” Dr. Moshfeghi runs SUNDROP, the Stanford University Network for the Diagnosis of Retinopathy of Prematurity, the largest network looking at the care of premature infants who may be at the greatest risk of newborn vision disorders. For more information, visit visunexmedical.com. REVIEW