News

ALCON ACQUIRES MIGS DEVICE MAKER TRANSCEND MEDICAL

Alcon is now a player in the growing microinvasive glaucoma surgery (MIGS) market as it entered into an agreement to acquire Transcend Medical, the maker of the CyPass micro-stent to treat mild to moderate glaucoma, according to a news release. Terms of the deal were not disclosed.

The CyPass micro-stent is implanted just below the surface of the eye. It is designed to treat less severe glaucoma by enhancing part of the natural drainage pathways of the eye with minimal tissue disruption, allowing the excess fluid in the eye to drain with the goal of reducing intraocular pressure (IOP) levels.

“We expect the MIGS technology to be a great addition to our device pipeline and to establish Alcon’s presence in this new surgical category to treat glaucoma,” Mike Ball, CEO of Alcon, said in a company news release. “If approved, it will provide a less invasive means of lowering IOP than traditional invasive glaucoma surgery, with the goal of lowering the dependency of topical ocular medication.

This acquisition also expands Alcon’s leadership in glaucoma and cataract treatment as part of our surgical business.”

A study with more than 500 patients with mild to moderate glaucoma undergoing cataract surgery randomized to either receive the MIGS micro-stent after cataract surgery

or undergo no further intervention met its primary and secondary endpoints in 2015 resulting in a 20% or greater reduction in IOP.

Privately-held Transcend Medical, based in Menlo Park, California, currently has CE Mark approval for the micro-stent in Europe and is awaiting FDA approval of the device.

The acquistion comes just 3 weeks after parent company Novartis outlined a wide-reaching restructuring plan in an attempt to revive its struggling Alcon unit with the goal of returning its eye care business to growth by the end of the year. As part of the transition, Novartis said it would narrow Alcon’s focus to surgical equipment and vision care products, including contact lenses. Alcon’s ophthalmic pharmaceuticals business moved to the company’s broader Pharmaceuticals Division. In addition, Mike Ball was appointed division head and CEO of Alcon, replacing Jeff George, who served as CEO at Alcon in April 2014.

The Transcend Medical acquisition is the first large move within the Alcon unit since the restructuring was announced. It comes about 5 months after Allergen’s $300 million purchase of AqueSys, maker of the MIGS device, XEN Gel Stent.

FDA Clears Sensimed Triggerfish Electronic Contact Lens

The US Food and Drug Administration (FDA) has allowed marketing of a one-time use contact lens that may help practitioners identify the best time of day to measure a patient’s IOP. Elevated IOP is often associated with the optic nerve damage that is characteristic of glaucoma.

The Triggerfish has a sensor embedded in a soft silicone contact lens that detects tiny changes or fluctuations in an eye’s volume. The device is worn for a maximum of 24 hours, transmitting data wirelessly from the sensor to an adhesive antenna worn around the eye. A portable data recorder worn by the patient receives information from the antenna and can transfer the data via Bluetooth to the clinician’s computer, which shows the range of time during the day the pressure of the eye may be increasing. The device does not actually measure IOP, is not intended to be a diagnostic tool and is not used to correct vision.

“The Triggerfish gives the clinician 24-hour continuous monitoring of changes in IOP patterns that otherwise could not be obtained,” William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a news release. “This information can help determine the most critical time of day for the clinician to measure the patient’s IOP.”

The Triggerfish is indicated for use in adults age 22 years and older under the direction and supervision of a health care professional. Clinical data supporting the marketing authorization of the Triggerfish included several studies of the safety and tolerability of the contact lenses and the effectiveness of the device measurement. The effectiveness of the device was demonstrated by showing an association between the Triggerfish device output and IOP fluctuation. The most common temporary side effects were pressure marks from the contact lens, ocular hyperemia, and punctate keratitis.

The FDA reviewed the data for the Triggerfish through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.

The Triggerfish is manufactured by Sensimed AG of Lausanne, Switzerland.

Visunex Receives Clearance for Widefield Imaging System

Visunex Medical Systems announced the FDA clearance of the Visunex Medical Systems PanoCam Pro Widefield 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, according to a company news release.

“We are launching the PanoCam Pro, which is a key product to help ophthalmologists and maternal clinicians identify vision disorders to help preserve vision in the NICU, OR, birthing centers and clinical offices. Our PanoCam Pro and PanoCam Review software will help clinicians identify vision disorders that may be reversed to preserve healthy vision,” Visunex Medical Systems CEO, Wei Su, PhD, said in the news release.

Early research done in Asia, Brazil and the United States suggests that 1 in 70 children born may have some form of vision disorder.

Newborn vision screening is already a clinically valued and established method for evaluating retinopathy of prematurity and retinoblastoma. The PanoCam Pro allows for complete visualization of the surface and sub-surface retinal pathologies. Being able to detect and monitor vision disorders with this technology represents a significant breakthrough, according to Visunex.

Newborn eye testing is most commonly performed when a child enters kindergarten at the age of 5 or 6. There is clinical data that suggests that newborn vision disorders may affect between 10 and 20 percent of newborns around the world. While many of these catalogued disorders may be thought of transient, 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 which is a significant vision disorder which may have long-term effects of a patient’s vision. Other vision disorders may be detected, and if detected early, can give caregivers the opportunity to intervene and provide the treatment and can to thwart vision loss and improve care pathways and newborn vision into adulthood.

“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, Darius M. Moshfeghi, MD, director of Pediatric Vitreoretinal Surgery and Ophthalmologic Telemedicine at Stanford University, said in the news release.

Dr. Moshfeghi runs the Stanford University Network for the Diagnosis of Retinopathy of Prematurity (SUNDROP) which is the largest network looking at the care of premature infants who may be at the greatest risk of newborn vision disorders.

Pyott Foundation Endows $2 Million to the AAO to Create Glaucoma Education Resource

The American Academy of Ophthalmology (AAO) announced that the David E.I. Pyott Foundation has pledged $2 million to the Academy’s educational foundation. Mr. Pyott is the former chairman of the board and CEO of the global pharmaceutical company, Allergan. His endowment represents the largest gift ever contributed to the Academy’s foundation from a single individual. It will enable the Academy to establish a unique online glaucoma education resource for physicians worldwide, according to an AAO news release.

The David E.I. Pyott Glaucoma Education Center will help speed online medical training in glaucoma treatment. It will provide an array of learning activities that hold the greatest promise for improving patient care. This resource will provide ophthalmologists with a peer network for them to discuss and manage challenging cases. It will also include interactive cases and simulations, an extensive searchable online library of clinical support materials and surgical videos, as well as patient-education resources. It is expected to launch at the end of 2017.

The Pyott Glaucoma Education Center will be a significant expansion of the Academy’s Ophthalmic News and Education (ONE) Network. The ONE Network is the Academy’s flagship educational resource for evidence-based medicine, surgical advancements and quality of care improvements.

Mr. Pyott’s endowment to the Academy Foundation through his private foundation follows a long history of significant contributions to ophthalmology, and specifically to glaucoma, the leading cause of irreversible, yet preventable, blindness worldwide.

“Having served as Allergan’s CEO for 17 years, I have an intimate connection with the glaucoma community,” said Mr. Pyott. “This is my way of giving back. I am delighted to continue a long and rewarding heritage of helping physicians everywhere speed improvements in patient outcomes.”

“David Pyott is an extraordinary philanthropist,” David W. Parke, II, MD, CEO of the AAO, said in the news release. “He is knowledgeable and personally experienced and engaged in the problem of treatable global blindness. This endowment will serve as a legacy gift for decades to come—helping current and future physicians around the globe, as well as providing resources for their patients. We are deeply grateful for his steadfast generosity that enhances our capability to protect sight and empower lives.”

Mr. Pyott has served on the advisory board of the AAO Foundation since 2002. For more than 30 years, the Foundation has worked to fund the Academy’s continuous efforts to deliver and uphold the highest standards in ophthalmic clinical education and patient care.

Mr. Pyott is president of the International Council of Ophthalmology Foundation and a board director at the Pan-American Ophthalmological Foundation. He also serves on the advisory board of the American Glaucoma Society Foundation.

EyeGate Pharma Acquires Jade Therapeutics

Eyegate Pharmaceuticals announced that it has acquired Jade Therapeutics, a privately-held company developing locally administered, polymer-based products designed to treat poorly-served ophthalmic indications, according to a company news release.

Under the terms of the agreement, in consideration for the outstanding equity interests in Jade, EyeGate will repay Jade liabilities of up to $300,000 and will issue 763,982 shares of EyeGate common stock, 90% of which were issued at the closing and 10% of which will be held back for 18 months to satisfy post-closing adjustments or indemnification obligations. The transaction also includes a cash earn-out provision calling for the additional payment of up to $2,156,249 contingent upon a Jade product receiving FDA marketing approval. With the transaction, Jade has become a subsidiary of EyeGate.

Jade’s proprietary, cross-linked, bio-erodible hydrogel technology has demonstrated a variety of unique and beneficial characteristics, whether employed alone or as a sustained-release drug-delivery vehicle. In conjunction with the acquisition, EyeGate will gain Jade’s research and development team, and the co-founders of Jade have been appointed to senior management or consulting roles within EyeGate. Barbara Wirostko, MD, co-founder and Chief Medical Officer of Jade has joined EyeGate as Chief Medical Officer, and MaryJane Rafii, PhD, co-founder and Chief Business Officer of Jade has joined in a consulting role to assist with ongoing business development activities.

Jade’s proprietary, cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S) is a modified form of the natural polymer hyaluronic acid (HA), which possesses unique physical and chemical properties such as viscoelasticity and water retention. EyeGate intends to initiate a clinical study for Jade’s lead product candidate for corneal epithelial defects in late 2016. n