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. ■

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. ■