Aerie shares 12-month results of Roclatan
IOP-lowering greater than individual components; no new adverse events
By René Luthe, senior editor
Glaucoma drug netarsudil/latanoprost ophthalmic solution 0.02%/0.005% (Roclatan, Aerie) continues to meet its safety and efficacy endpoints with 12-month results of its Mercury 1 trial showing no new adverse events and no drug-related serious or systemic adverse events. The trial also measured IOPs of subjects at 8 a.m., 10 a.m. and 4 p.m. Roclatan’s ability to lower IOP exceeded that of both its components, netarsudil (Rhopressa) and latanoprost, in a range from 1 to 3 mmHg, and demonstrated consistent levels of IOP across the 12-month study period. The findings are consistent with Mercury 1’s 90-day safety and efficacy period for the fixed-dose combination therapy.
“Roclatan addresses patient compliance with once-daily dosing while producing IOP reductions greater than the single agents alone,” says Janet Serle, MD. “[Roclatan achieves] the target pressures recommended for glaucoma patients in the majority of subjects, [while] demonstrating tolerability and safety over one year of dosing,” says Dr. Serle, professor of Ophthalmology and Glaucoma Fellowships Director at Icahn School of Medicine at Mount Sinai School of Medicine, in NYC.
“Mercury 1 also confirmed that netarsudil was additive to latanoprost in the fixed-dose combination and, as a single agent, Rhopressa was similarly efficacious to latanoprost in patients with baseline IOP below 25 mmHg. Rhopressa, if approved, would be the only medication that targets the diseased trabecular meshwork in glaucoma patients,” she said. OM
OCT can provide a window into neurodegenerative conditions
By Louise Gagnon, contributing editor
Imaging tools like optical coherence tomography are demonstrating the relationship between changes in the eye and the presence of neurological conditions such as multiple sclerosis (MS) and Alzheimer’s Disease (AD).
A session at this year’s meeting of the Association for Research in Vision and Ophthalmology focused on retinal abnormalities and neuropathology, and involved several studies using OCT whereby individuals affected by neurological deficits experienced changes in the eye, as evidenced by OCT.
“More and more studies are looking at whether we can use a measure whereby we are looking at the eye to tell us what is the status of the brain,” said Mays Antoine El-Dairi, assistant professor of Ophthalmology and pediatric neuro-ophthalmologist at Duke University in Durham, N.C., who helped moderate the session. “There are neurological diseases that manifest in the eye. Some are obvious and some are not so obvious. With MS, for example, patients can have thinning of the retinal nerve fiber layer [RNFL] and ganglion cell layer.”
One study, for example, found that the use of spectral-domain OCT could significantly correlate total macular thickness to parietal cortical atrophy on magnetic resonance imaging (MRI), backing the hypothesis that neurodegenerative conditions can be reflected by alterations in the retina.
Mark Kupersmith, MD, a professor of Ophthalmology, Neurology, and Neurosurgery at the Icahn School of Medicine at Mount Sinai Health System, NYC, agreed that the eye, specifically the optic nerve, is most useful as a biomarker for MS.
“A third of your brain has to do with vision,” said Dr. Kupersmith, the session’s other moderator. “The area where it [the link between the eye and the brain] has been profoundly demonstrated and is useful [to] is MS. The retina is central nervous system tissue. You can measure the thinning and loss of the optic nerve fibers which parallels the debilitation and progression of MS.
“As a result, many MS [health] services track patients using the eye,” explained Dr. Kupersmith. “It’s quicker and more comfortable [for MS patients]than imaging the brain with MRI.”
NO HELP WITH AD
Another analysis presented during the session found peripapillary retinal nerve fiber layer thickness (RNFL) and total macular thickness were not significantly reduced in patients with amyloid-positive, early onset AD without glaucoma when compared to healthy controls.
The finding is consistent with other data on imaging the retina in AD. When cell loss in the retina is observed in patients who have AD, the condition is already advanced. Because of this fact, monitoring retinal changes cannot offer a great degree in evaluating disease progression, noted Dr. Kupersmith.
“It’s unlikely we will make any breakthrough [in AD] by looking at the eye,” he said.
Data from another investigation found an increased prevalence of structural damage in the inner retina in patients with severe traumatic brain injury (TBI) versus patients with mild TBI.
As with imaging the retina in AD, Dr. Kupersmith said imaging the retina in TBI will not likely produce information that will inform any treatment decisions or help track disease progression. OM
Female MDs still earn 18% less than male peers
Doximity’s first compensation report finds women ophthalmologists on average earn $65,000 less
By Robert Stoneback, associate editor
In 2012, female ophthalmologists were reimbursed a median of $0.56 for every Medicare dollar reimbursed to male ophthalmologists. In 2017, using annual income as a comparator, women ophthalmologists still came up short: a new study from the website Doximity shows they earn 18% less per year than their male counterparts. These findings parallel the older data published earlier this year in JAMA Ophthalmology.
On average, men in the ophthalmic field earned approximately $368,184 a year, while women earned $302,603, a difference of 18%, according to Doximity. Average annual compensation for all ophthalmologists was recorded as $357,000. Data for the study were collected between 2014 and 2017. This is the first annual physician compensation report released by Doximity, which serves as a social network site for physicians and advanced-practice clinicians.
48 SPECIALTIES EXAMINED
The report examined the earnings of physicians in 48 specialties, in different cities across America. Doximity found no medical specialties in which women earned more than men.
Three specialties had a 20% payment gap, the highest recorded: vascular surgery (an average of $453,580 for men, $364,781 for women); occupational medicine ($267,537 for men, $213,616 for women) and pediatric endocrinology ($209,891 for men, $168,424 for women). The lowest difference was 14%, in hematology; there, women earned $309,052 and men $360,695.
On average, females were found to make $91,284 less, or 26.5%, than males across the country. The report did not distinguish between academic and non-academic physicians.
The full report is available to registered Doximity users.
MORE THAN 36,000 RESPONSES
Doximity includes 70% of all U.S. doctors as members, and included responses from more than 36,000 full-time, licensed doctors across all specialties for its report. Study data were drawn from self-reported compensation surveys of U.S. physicians who practice at least 40 hours per week. The study authors controlled for how long each provider practiced medicine, specialty choice and the self-reported average hours per week.
The JAMA Ophthalmology paper “Differences in Clinical Activity and Medicare Payments for Female vs Male Ophthalmologists” noted that female ophthalmologists, at a median reimbursement of $0.56, would be reimbursed $1.5 million less than male ophthalmologists, at a median of $1, over a 30-year career. OM
PRODUCT UPDATES
INSIGHT INSTRUMENTS
1 Insight Instruments recently released a new single-use lens system, the Pivot, which can transition between a 130° HD widefield lens for peripheral viewing and a 72° Ultra HD lens for 3D viewing. The Pivot can be mounted onto either an Insight Super View vitreoretinal or Oculus BIOM wide-angle viewing system.
www.insightinstruments.com
BESSE MEDICAL
2 Besse Medical, part of AmerisourceBergen, recently acquired Physician Office Drug Inventory System (PODIS), a cloud-based inventory and billing reconciliation system. The PODIS platform, now exclusively offered through Besse Medical, will receive a series of enhancements. These include integrating distribution from Besse Medical and pharmacy partners (including electronic ordering and pre-labeling of products), and full electronic data interchange capabilities, wrapping-in purchase orders, invoicing and payment information.
www.besse.com
NIDEK/MEDMONT
3 Nidek recently partnered with Australia-based Medmont International to offer the Medmont E300 Corneal Topographer to U.S. ophthalmologists. “We were impressed by the [E300’s] ability to capture from limbus to limbus, plus having a noninvasive and accurate way of detecting dry eye was a big plus, too,” said Nidek CEO and president Motoki Ozawa, via press release. Nidek is happy to be able to offer this instrument to MDs in the United States.”
www.nidek.com
www.medmont.com
QUICK BITS
A resubmitted New Drug Application for Ocular Therapeutix’s Dextenza has been rejected by the FDA. Ocular Therapeutix was notified of the FDA’s decision in a Complete Response Letter sent this summer, noting that it could not approve the resubmitted NDA in its present form. The CRL referred to deficiencies in Dextenza’s manufacturing processes and analytical testing related to the drug’s manufacture. Amar Sawhney, PhD, president and CEO of Ocular Therapeutix, said his company plans to work closely with the FDA to satisfy “the requirements related to the NDA.” He also noted that there were no clinical issues related to Dextenza’s safety or efficiency.
Katena Products has purchased NuPak Medical Ltd. NuPak offers contract manufacturing services to the medical device industry, including product assembly and packaging and injection-molding in controlled environments. NuPak serves manufacturers in several specialties, including ophthalmology, and will continue to supply its existing customer base.
Konan Medical recently attained a CE mark for its newest device, the EvokeDx, a visual evoked potentials and electroretinogram vision diagnostics platform. It is now approved in Europe for objective assessment of central vision function, including the diagnosis of glaucoma. EvokeDx will be featured at the European Ophthalmology meeting, the ESCRS in Lisbon in October 2017.
A report from Decision Resources Group predicts that Regeneron’s Eylea anti-VEGF medication will “dominate” the wet AMD market until 2018, at which point it is expected to lose ground to new, emerging products that offer extended dosing duration or lower cost, compared to current therapies. The report also expects the total AMD market to grow from approximately $4.2 billion in 2016 to more than $7.2 billion in 2026.