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NEWS SPECTRUM

I-MED PHARMA ANNOUNCES DISTRIBUTION AGREEMENTS

I-Med Pharma Inc. announced a new distribution agreement with OcuSoft Inc. to make the I-Pen Osmolarity System available in the United States. On Dec. 22, 2017, the U.S. Food and Drug Administration (FDA) issued an Acceptance Review Notification for the I-Pen Osmolarity System 510k submission. This distribution partnership will officially commence upon final FDA approval of the 510k, which is anticipated in the first quarter of 2018.

I-Med Pharma, Inc. also signed an exclusive agreement with Imex for distribution of its I-Pen Tear Osmolarity System, I-Drop viscoadaptive dry eye drops, I-Plug punctum plugs, and other dry eye products for Spain and Portugal. ■

AMPLEYE NOW OFFERED IN REDUCED DIAMETER OPTIONS

Art Optical announced that its Ampleye scleral lens design is now available in 15.0mm and 15.5mm diameter options; the standard design has a 16.5mm diameter. The new smaller-diameter availability, combined with Ampleye’s recent 510(k) U.S. Food and Drug Administration clearance for therapeutic management of ocular surface disease and dry eye, expands the range of potential Ampleye patients exponentially, according to the company.

Ampleye is available in diameters from 15.0mm to 17.0mm. Additional design options include anterior-surface toric and multifocal optics, quadrant-specific control technology, and Tangible Hydra-Peg (Tangible Science) surface coating on lenses made in Optimum (Contamac) materials.

Fitting the reduced-diameter Ampleye does not require additional diagnostic lenses, as a sagittal depth conversion calculation from the 16.5mm diagnostic lens will produce the same successful initial fitting results, according to the company. Or, for practitioners preferring to work with smaller scleral lenses, nine-lens diagnostic sets are available in the 15.0mm/15.5mm diameter for immediate shipment. ■

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TEARLAB SUBMITS 510(K) FOR U.S. FDA CLEARANCE OF TEARLAB DISCOVERY PLATFORM

TearLab Corporation has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for the potential clearance of its TearLab Discovery Platform, the company’s next-generation in-vitro diagnostic testing system. The submission covers the TearLab Discovery Platform and a test card measuring the matrix metalloproteinase-9 (MMP-9) inflammatory biomarker. TearLab Discovery will also be capable of performing TearLab’s current FDA-cleared tear osmolarity test.

TearLab plans to file for Waiver categorization with the FDA under the Clinical Laboratory and Improvement Amendments (CLIA) after it receives FDA 510(k) clearance for the TearLab Discovery Platform to allow the test to be performed at the point-of-care. Both the MMP-9 predicate device and the current TearLab osmolarity test have existing CLIA Waivers to allow point-of-care testing. In the interim, the company will continue to build the clinical data package for the commercial launch of the TearLab Discovery Platform, which it expects after securing both the FDA clearance and the CLIA waiver. ■

LATEST INNOVEGA PATENT ALLOWANCE AWARDED

The U.S. Patent and Trademark Office issued two notices of allowance to complement the 11 U.S. patents already issued to Innovega Inc.

Innovega’s latest allowances relate to two patents. The first, “Method and Apparatus for Constructing a Contact Lens with Optics,” relates to a contact lens that has regular vision correction optics and a central lenslet that enables focusing a display in the spectacle plane as well as a light polarizing filter that blocks display light from the surrounding region. The second allowance, “Contact Lens,” claims methods of regulating water vapor transmissibility while maintaining oxygen transmissibility in ultra-high-oxygen-permeable lens materials. Both patents were filed by Jerome Legerton, William Meyers, and Jay Marsh. Innovega also received notices of allowance in 2017 from Korea and the European Union for the foundational patent for its technology. ■

DR. NEIL GAILMARD SIGNS OFF FROM OPTOMETRIC MANAGEMENT TIP OF THE WEEK

After penning 814 tips and after nearly 16 years, Neil Gailmard, OD, MBA, has retired from writing the popular weekly e-newsletter, Optometric Management Tip of the Week; he will remain on the masthead as Editor.

IDOC, a privately held alliance of independent optometrists in the United States, announced that several of its Optometric Practice Management Consultants are part of a new team taking over writing the e-newsletter. The new team of authors are all experts in various areas of optometric practice management (e.g., finance, marketing, business management). The new team of authors includes Dr. Steve Vargo, IDOC Practice Optometric Consultant; Dr. Susan Daly, IDOC Optical Management Consultant; Nathan Hayes, IDOC Practice Finance Consultant; Maddie Langston, IDOC Marketing Consultant; Dr. Gina Wesley of Complete Eye Care of Medina, MN; and Dr. Eric White of Complete Family Vision Care in San Diego. ■

NOVALIQ ESTABLISHES U.S. SUBSIDIARY IN MASSACHUSETTS

Novaliq GmbH announced the formation of its new subsidiary, Novaliq Inc., which will be located in Cambridge, MA. The new Cambridge-based office will be headed by Novaliq’s founder and current chief innovation officer (CIO) Bernhard Günther. Mr. Günther will build the new U.S. organization to leverage the advantages and the potential of the water-free EyeSol drug delivery technology and innovative products in the United States. Novaliq Inc. is a 100% subsidiary of Novaliq GmbH. ■

NICOX APPOINTS TOMAS NAVRATIL, PHD, HEAD OF DEVELOPMENT

Nicox SA appointed Tomas Navratil, PhD, vice president and head of development. In this newly-created position, Dr. Navratil will be responsible for leading all of the company’s non-clinical and clinical development activities. He will report to Michael Bergamini, PhD, executive vice president and chief scientific officer of Nicox.

Dr. Navratil brings to Nicox significant experience in the biotechnology industry and has been involved with the discovery and development of new chemical entities, novel medical devices, and biodegradable implant formulations focused on improving drug delivery, Phase 1-4 clinical programs, and regulatory submissions to the U.S. Food and Drug Administration and the European Medicines Agency.

Prior to joining Nicox, he served as senior vice president of development at Envisia Therapeutics, a privately held biotechnology company focused on the development of novel ocular therapies. Before that, he was at Parion Sciences, where he served as executive director of clinical research and product development. Previously, Dr. Navratil held several director-level positions in drug discovery and clinical development at Inspire Pharmaceuticals, most recently as director, Medical & Scientific Affairs. ■

GLOBAL CONTACT LENS FORUM TO BE OFFERED AGAIN AT VEE

Once again, Vision Expo will offer The Global Contact Lens Forum (GCLF), a four-hour education “meeting within a meeting” that provides attendees with up-to-the-moment information and insight about what is happening in the world of contact lenses. The program, which is being held on Thursday, March 15, will be part of the International Vision Expo East 2018. Held at the Javitz Center in New York, the GCLF is co-directed by S. Barry Eiden, OD, and Louise Sclafani, OD.

The forum will kick off with a session that tackles the topic of “Future Trends in Contact Lenses and Ocular Surface Disease, where have we been and where are we going?” Other sessions will highlight the management of complex contact lens patients as well as how to successfully establish and develop a contact lens specialty practice.

The GCLF is supported by CooperVision and Johnson & Johnson Vision and is supported by an unrestricted educational grant from Bausch + Lomb. For more information, visit http://east.visionexpo.com/Education/Highlights . ■

ABB OPTICAL GROUP ADDS MIKE EVANS TO SALES TEAM

ABB Optical Group has hired industry veteran Mike Evans as the company’s area sales director of the west. Prior to joining ABB Optical, Mr. Evans was the vice president of sales for Professional Eyecare Resource Co-Operative (PERC), a doctor alliance group with 4,000 members, and Infinity Vision Alliance (IVA). He previously held senior sales positions with Johnson & Johnson/Vistakon as well as several other healthcare-focused companies.

Additionally, Brad Amstutz, who managed the company’s mid-Atlantic sales team, has been promoted to area sales director of the east. Mr. Amstutz also will focus on continued growth of daily disposables, specialty lenses, and lab orders as ABB Optical’s area sales director of the east.

In addition, Glenn Senese, who formerly held the east sales director role, will move to the new position of director of new business development. In his new role, Mr. Senese will focus on developing new business for ABB Optical, including maximizing lab opportunities. ■

NOVABAY RECEIVES STOCKHOLDER APPROVAL FOR PROPOSED FINANCING AGREEMENT

NovaBay Pharmaceuticals, Inc. announced stockholder approval to issue NovaBay common stock as part of a $10.32 million financing agreement with Ch-gemstone Capital (Beijing) Co., Ltd. The vote was announced at a special meeting of stockholders held Dec. 20, 2017.

On Nov. 20, 2017, NovaBay entered into an agreement with Ch-gemstone Capital (Beijing) Co., Ltd. to purchase 2.4 million shares of NovaBay common stock for $10.32 million. The private placement was expected to close in January, subject to the satisfaction of certain closing conditions, including approval for funds transfer by the applicable regulatory authorities in China. ■

CHICAGO COLLEGE OF OPTOMETRY WELCOMES NEW DEAN

Kathleen H. Goeppinger, PhD, president and CEO of Midwestern University, announced the promotion of Melissa Suckow, OD, to dean of the Chicago College of Optometry (CCO). Dr. Suckow joined Midwestern University in 2015 and has served as CCO’s associate dean of Academic Affairs for the past year.

Previously, Dr. Suckow was an assistant professor at the New England College of Optometry. In 2011, she joined the clinical faculty of the Illinois College of Optometry and was a preceptor for third- and fourth-year students on rotation at the Illinois Eye Institute at Princeton School.

As dean of the Chicago College of Optometry, Dr. Suckow will provide guidance and leadership for CCO, which welcomed its inaugural class in the fall of 2017. ■

INDUSTRY BRIEFS

  • X-Cel Specialty Contacts announced a simplified pricing and warranty structure for its Atlantis Scleral lenses, featuring unlimited exchanges for 90 days and true paperless returns. Additionally, X-Cel has announced a new single price structure for all standard, toric, and large-diameter Atlantis Scleral designs.
  • AccuLens announced that it has upgraded its current CNC/DAC lathes as well as all ancillary equipment. Upgrades include high-speed air-cooled spindles, which allow a higher level of optics to be achieved. With these machine updates, the capability to manufacture lenses that reduce spherical aberrations (high-definition optics) is increased due to the shorter polishing times, according to the company. AccuLens says it has the capability to manufacture custom scleral and corneal GP designs in a wide range of multifocal options, and these upgrades expand this ability.
  • Shire plc announced that Xiidra (lifitegrast ophthalmic solution 5%), a twice-daily eye drop solution indicated for the treatment of the signs and symptoms of dry eye disease in adults, has been approved in Canada, marking the first international approval for the treatment outside of the United States. Xiidra will be available for patients in Canada early this year. 
  • According to Sun Pharmaceutical Industries, the U.S. Food and Drug Administration (FDA) has accepted Sun Pharma’s new drug application (NDA) for OTX-101 for dry eye disease. OTX-101 (cyclosporine A, ophthalmic solution) 0.09% is a novel nanomicellar formulation in a clear, preservative-free, aqueous solution. The NDA was filed by Sun Pharma’s wholly owned subsidiary, Sun Ophthalmics. If eventually approved by the FDA, OTX-101 would be the third pharmaceutical drug for dry eye disease approved in the U.S. market. 
  • The World Council of Optometry (WCO) and the American Academy of Optometry (Academy) will be co-hosting the 3rd World Congress of Optometry in conjunction with the Academy meeting tentatively to be held in Orlando, FL on Oct. 23 to 28, 2019. The meeting will feature joint CE tracks. In 2019, the 3rd World Congress will showcase the latest advances in vision sciences, research in optometry, optics, and contact lens cutting-edge technology, recognizing the United States as a world benchmark in vision sciences. Also, the partnership with COPE-approved continuing education credit providers in the United States will ensure that the academic standards for the conference and workshops meet global education quality standards, according to the organizers. Information on all aspects of the meeting will be available in the future at www.worldcongressofoptometry.org  and www.aaopt.org .
  • For Eyes Optical, a division of GrandVision NV, has launched Healthy Eyes, a savings program that aims to provide affordable, quality eye care to patients by tailoring its offerings to organizations and companies. Those organizations and companies can sign up for Healthy Eyes and receive benefits such as 10% off eye exams, 30% off complete frames and lenses, 20% off conventional contact lenses, 10% off disposable contact lenses, 10% off sunglass frames, and 10% off accessories. Healthy Eyes will become a regular offering for businesses at all For Eyes retail locations and online at www.foreyes.com/HealthyEyesSavingsPlan .
  • Johnson & Johnson Vision, through its operating company Johnson & Johnson Vision Care Inc., has formed a collaboration with Narayana Nethralaya Foundation and Medical Research Foundation for the discovery and validation phases of developing diagnostic tools that can identify objective biomarkers for ocular response to contact lens wear that can be used to identify a person’s unique vision-care needs to help facilitate the matching of vision correction options.
  • EyeGate Pharmaceuticals, Inc. announced the promotion of Sarah Romano from interim CFO to CFO. Ms. Romano joined EyeGate in 2016, serving as corporate controller. She was promoted to interim CFO on Feb. 1, 2017. Prior to joining EyeGate, Ms. Romano served as assistant controller at TechTarget and corporate controller at Bowdoin Group, a healthcare-focused executive recruiting firm. Previously, she held financial reporting positions of increasing responsibility at SoundBite Communications until its acquisition by Genesys in 2013, and she was a senior financial reporting analyst at Cognex Corporation.
  • Opternative, Inc. announced that Brent Rasmussen has joined the company as CEO and as a member of the Board of Directors. Rasmussen recently served as CEO at Halo Group and previously was COO and president, North America, at CareerBuilder.