News

Zika and Glaucoma Linked for First Time in New Study

A team of researchers in Brazil and at the Yale School of Public Health has published the first report demonstrating that the Zika virus can cause glaucoma in infants who were exposed to the virus during gestation.

Exposure to the Zika virus during pregnancy causes birth defects of the central nervous system, including microcephaly. According to a news release, Brazilian and Yale School of Public Health researchers had reported early during the microcephaly epidemic that the virus also causes severe lesions in the retina. However, until now, there has been no evidence that Zika causes glaucoma, which can result in permanent damage to the optic nerve and blindness.

“We identified the first case where Zika virus appears to have affected the development of the anterior chamber or front portion of the eye during gestation and caused glaucoma after birth,” said Albert Icksang Ko, MD, professor at the Yale School of Public Health and coauthor of the study published in Ophthalmology.1 Dr. Ko has longstanding research collaborations in Brazil and has worked with local scientists since Zika first appeared in the Americas to better understand the birth defects that are caused by the virus and the risk factors for Zika Congenital Syndrome, according to the release.

While conducting their investigations of the microcephaly epidemic in Salvador in Northeast Brazil, the researchers identified a 3-month-old boy who was exposed to Zika virus during gestation. While no signs of glaucoma were present at the time of birth, the infant developed swelling, pain, and tearing in the right eye. The research team diagnosed glaucoma as the cause of symptoms and together with local ophthalmologists, performed a trabeculectomy, an operation that successfully alleviated the pressure within the eye.

Although this is the first known incidence of glaucoma in an infant with the Zika virus, clinicians treating patients with Zika should be aware that glaucoma is another serious symptom of the disease that should be monitored, said the investigators. Additional research is needed to determine if glaucoma in infants with Zika is caused by indirect or direct exposure to the virus, either during gestation or postpartum.

The World Health Organization declared an end to its global health emergency over the spread of the Zika virus, prompting dismay from some public health experts confronting the epidemic. An agency advisory committee said it ended the emergency — formally known as a Public Health Emergency of International Concern — because Zika is now shown to be a dangerous mosquito-borne disease, like malaria or yellow fever, and should be viewed as an ongoing threat met as other diseases are, sometimes with help from the World Health Organization.

1. Freitas BP, Ko AI, Khouri R, et al. Glaucoma and congenital Zika syndrome [published online ahead of print]. Ophthalmology. November 29, 2016. doi: http://dx.doi.org/10.1016/j.ophtha.2016.10.004.


American Academy of Ophthalmology Statement on Rep. Tom Price, MD, to Lead HHS

Following President-elect Donald Trump’s decision to appoint Rep. Tom Price, MD, to head the Department of Health and Human Services, David W. Parke, II, MD, CEO, American Academy of Ophthalmology, issued the following statement:

“Rep. Tom Price, MD, one of the nation’s most ardent champions of quality patient care, is an excellent choice to serve as secretary of the US Department of Health and Human Services. We can think of no better voice to lead our nation’s critical health care programs, including Medicare, the Food and Drug Administration and the National Institutes of Health. We’ve worked side-by-side with Rep. Price on numerous issues since he took office in 2005, and find him to be creative, thoughtful and committed to the idea that quality patient care must govern all policies that impact our nation’s health care system. Rep. Price is a trusted individual who works tirelessly to ensure that the federal government supports, rather than hinders, physicians’ abilities to ensure best outcomes. The American Academy of Ophthalmology urges our leaders in the US Senate to take swift action and confirm Rep. Price for this critical position.”


Sun Pharma Launches First Branded Ophthalmic Product, BromSite, in US

Sun Pharma announced the launch of BromSite (bromfenac ophthalmic solution) 0.075% in the United States. A nonsteroidal antiinflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery, BromSite will be marketed by Sun Ophthalmics, the company’s branded ophthalmic business division. BromSite is the first branded product launched by the company in the US, following its focus on specialty business.

Approved by the FDA on April 8, 2016, BromSite is the first NSAID approved to prevent ocular pain and treat inflammation in the eye following cataract surgery. Developed by California-based InSite Vision, a subsidiary of Sun Pharma, it is also the first bromfenac ophthalmic solution formulated in DuraSite, a polymer-based drug delivery system that is used to improve drug solubility, absorption, bioavailability, and residence time as compared to conventional topical therapies.

“I am pleased that BromSite is now available to eye care practitioners. Multiple clinical studies have demonstrated the drug’s efficacy in preventing ocular pain and reducing inflammation in patients undergoing cataract surgery,” Richard L. Lindstrom, MD, founder and attending surgeon of Minnesota Eye Consultants and Adjunct Professor Emeritus at the University of Minnesota, Department of Ophthalmology, said in the news release. “These clinical results, in combination with BromSite’s unique label to prevent ocular pain, will make it a welcome addition to cataract surgeons’ armamentarium.”


FDA Approves Allergan’s Xen Gel Stent for Refractory Glaucoma

Allergan announced that the FDA has cleared the Xen Glaucoma Treatment System, which consists of the Xen45 Gel Stent and the Xen Injector. The Xen Glaucoma Treatment System reduces IOP in patients and is indicated for the management of refractory glaucomas, where previous surgical treatment has failed, or in patients with primary open-angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy. According to a news release, the Xen is implanted through an ab interno approach and reduces IOP by creating a new drainage channel with a permanent implant that becomes flexible. This provides a new treatment option for the millions of Americans with refractory glaucoma.

In the US pivotal trial conducted in refractory glaucoma patients, Xen reduced IOP from a mean medicated baseline of 25.1 (+3.70) mm Hg to 15.90 (+5.20) mm Hg at the 12-month visit (n = 52). The mean baseline number of IOP-lowering medications was 3.5 (±1.0) versus an average use of 1.7 (±1.5) medications at 12 months. Xen also allows for keeping postoperative options open, allowing physicians to utilize other IOP-reduction techniques in the event that they are still needed after surgery.

“Xen is a new option that provides an opportunity for surgical intervention in refractory glaucoma patients. Xen can effectively lower IOP, in fact, studies have shown that at 12 months using Xen, patients used, on average, less IOP lowering drops than they did before Xen was implanted,” Robert N. Weinreb, MD, chairman and distinguished professor of Ophthalmology at the University of California, San Diego, said in a company news release.

Allergan plans to launch the Xen Glaucoma Treatment System in the US in early 2017. More than 10,500 Xen Gel Stents have already been distributed worldwide. Xen is CE marked in the European Union, where it is indicated for the reduction of intraocular pressure in patients with primary open angle glaucoma where previous medical treatments have failed. It is also licensed for use in Canada, Switzerland, and Turkey.


FDA Confirms a 510(k) De Novo Path for EyeGate’s Ocular Bandage Gel

EyeGate Pharmaceuticals announced that, following a presubmission meeting with the FDA, it plans to pursue US regulatory clearance of its EyeGate Ocular Bandage Gel (OBG) via the de novo 510(k) pathway. EyeGate OBG is the lead product candidate from the company’s cross-linked, thiolated carboxymethyl hyaluronic acid (CMHA-S) platform. The company plans to release topline results by year-end, from its initial pilot study evaluating the ability of EyeGate OBG to accelerate ocular surface reepithelialization following PRK.

“We are extremely encouraged by our dialogue thus far with the FDA around EyeGate OBG, and are pleased to have a clear clinical and regulatory path forward for our first-in-kind eye drop that could accelerate recovery from post corneal surgery and injury,” Stephen From, president and CEO of EyeGate, said in the news release. “We believe that the De Novo process, which is for medical devices without predicates, provides evidence of the novelty of our EyeGate OBG product. We look forward to announcing the top-line data from our PRK pilot study by the end of the year.”

The EyeGate OBG is a synthetic biocompatible CMHA-S hydrogel, capable of coating the ocular surface and designed to resist degradation under conditions present in the eye. This prolongs residence time of the bandage on the ocular surface, addressing the limitations of current non-cross-linked hyaluronic acid formulations. Additionally, cross-linking allows the product’s viscosity to be modified to meet optimum ocular needs. n