- CooperVision announced the creation of a unified, full-scope Global Professional Affairs organization. The group will be led by Karen Walsh, MCOptom, PGDip, who has been promoted to senior director in conjunction with the development. Prior to joining CooperVision in 2021, Dr. Walsh was an educator, researcher, and author at the Centre for Ocular Research and Education at the University of Waterloo. She also served with Johnson & Johnson Vision as professional affairs manager for the U.K. and Ireland. Dr. Walsh is a Fellow of the American Academy of Optometry, the International Association of Contact Lens Educators, and the British Contact Lens Association. She also is a member of the U.K. College of Optometrists and holds a postgraduate diploma in clinical optometry from City University, London.
- Haag-Streit Group has appointed Olaf Felske as the new CEO for Haag-Streit USA. Mr. Felske begins his new role immediately and will report to Thomas Bernhard, Haag-Streit Group CEO. Jeff Sieve, previously CEO and president, will now solely focus on the role of president, highlighting his ongoing and integral role within Haag Streit USA. Over the past decade, Mr. Felske advanced in leadership roles at Medtronic, acquiring extensive expertise in both organic and inorganic growth.
- Harrow announced that it has changed its corporate name from Harrow Health Inc. to Harrow Inc. to align with the company’s current five-year strategic plan, which includes an exclusive focus on eyecare pharmaceuticals.
- Bausch + Lomb has completed its acquisition of Xiidra (lifitegrast ophthalmic solution 5%), a nonsteroid eye drop approved to treat the signs and symptoms of dry eye disease focusing on inflammation associated with dry eye. As part of the transaction, Bausch + Lomb also acquired libvatrep (also known as SAF312), an investigational compound being studied for the treatment of chronic ocular surface pain; and AcuStream technology, an investigational device that may have the potential to facilitate precise dosing and accurate delivery of certain topical ophthalmic medications to the eye, according to the company.
- Bruder Healthcare, a Hilco Vision Company, announced the addition of Steven Fusco to its team as the national account director. In his new role, he will develop initiatives, foster partnerships, and accelerate growth opportunities to expand the company’s reach and impact within the eyecare sector. Prior to joining Bruder Healthcare, Mr. Fusco served as the senior director of business development at Lexitas, an ophthalmic product development company, and co-founder of MYZE, an eyecare patient engagement platform. He held sales management positions with Santen and Eyevance.
- Sight Sciences Inc. appointed Matthew Link as its chief commercial officer. Mr. Link has more than 20 years of experience building teams and leading innovation in the health care and medical technology industries, most recently serving as managing partner at Orion Healthcare Advisors LLC, consulting services provider.
- NovaBay Pharmaceuticals Inc. and BioStem Technologies Inc. announced an agreement under which NovaBay has been granted the right to commercialize BioStem Technologies’ Amniotic Tissue Allograft, which is intended for use as a protective covering during the repair of ocular surfaces. NovaBay intends to commercialize the prescription-only product as Avenova Allograft to leverage its Avenova eyecare brand and encourage use with other Avenova products. Medically necessary procedures with the Avenova Allograft will be reimbursed through Medicare.
- Link Biologics Limited and Théa Open Innovation announced that they have entered into an agreement to co-develop Link_TSG6 for the treatment of dry eye disease (DED) and other ophthalmology indications worldwide, excluding Asia. According to the company, Link_TSG6 is a biological drug based on human TSG-6, a protein that serves an intrinsic role in protecting tissues from inflammatory damage. Link Biologics was spun off from the University of Manchester in 2021 based on the research of Professor Tony Day and Dr. Caroline Milner, who are both co-founders of the company. Under the terms of the license and co-development agreement, in parallel with an equity investment from Théa Open Innovation, Link Biologics will be responsible for all DED research and development up to the end of phase 2 trials, with Théa taking over responsibilities, including commercialization, thereafter.
- Art Optical Contact Lens Inc. recently debuted the new KattCloud platform. The MoonLens Modern Myopia Management Orthokeratology Lens System features a unique orthokeratology lens design that integrates OTZ technology, a proprietary algorithm allowing micro-customization in one-micron steps. This system allows each MoonLens to be individually designed to the specific size, shape and effect based on the patient’s age, refraction, topography, and visual needs. Utilizing the new KattCloud proprietary cloud-based software, the MoonLens fitting process is now supported with a comprehensive platform that delivers lens customization in a simple, convenient, and efficient process, yielding over 90% first-fit success, according to Art Optical.
- BostonSight held its annual FitAcademy Retreat for Residents at the New England College of Optometry (NECO) in Boston on Sept. 15-16. This year marks the fifth anniversary of this free event for emerging clinicians in cornea and contact lens residencies and fellowships at schools and colleges of optometry and accredited fellowship sites throughout the U.S. and Canada. This year, 29 cornea and contact lens residents attended in person for the full curriculum, which included hands-on wet lab training. FitAcademy is led by Karen Carrasquillo, OD, PhD, and taught by BostonSight staff Bita Asghari, OD, associate director of clinical education; Chirag Patel, OD, associate director of innovative technologies; Alan Kwok, OD, director of PROSE Network Clinical Relationships; and Daniel Brocks, MD, chief medical officer and cornea specialist. Invited faculty included Clark Chang, OD, MSA, MSc, of Wills Eye Hospital; John D. Gelles, OD, of the Cornea and Laser Eye Institute-Hersh Vision Group and the CLEI Center for Keratoconus; Daddi Fadel, DOptom, of the Center for Ocular Research and Education; Chantelle Mundy, OD, of The Ohio State University College of Medicine; Anita Gulmiri, OD, of NECO and Tarsus Pharmaceuticals; and Jennifer Liao, OD, of NECO.
- CooperVision announced its ninth annual search for the nation’s Best Practices and student honorees. All U.S. independent and corporate optometry practices currently fitting any brand of contact lenses are eligible to apply, although the program is not solely focused on such. Best Practices applicants are encouraged to share their personal insights and experiences in areas such as industry advancement, community impact, patient experience, specialty services, and team building. Best Practices scholarship recipients will join the 2024 honorees at the annual Best Practices Summit, a two-day educational event. Applicants must be third-year optometry students currently in good academic standing at a U.S. optometry school who demonstrate exceptional leadership and/or participation in school and community activities, honors, and work experience. All applications can be submitted at coopervision.com/practitioner/best-practices through Nov. 27.
- Treehouse Eyes recently made key additions to its leadership team that will enable the company to accelerate growth in both its partnership and dedicated center models. Thanh Mai, OD, joined Treehouse Eyes as vice president of innovation and myopia development. Rachel Donovan joined Treehouse Eyes in the newly created role of vice president of marketing. Kyle Bigos is an eyecare industry veteran who has joined Treehouse Eyes in a new role as director of center operations.
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FDA ISSUES WARNING LETTERS TO FIRMS MARKETING UNAPPROVED EYE PRODUCTS
• THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) has issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law. These warning letters are part of the agency’s ongoing effort to protect Americans from potentially harmful ophthalmic products.
Eye products addressed in the eight warning letters are illegally marketed to treat conditions such as conjunctivitis, cataracts, glaucoma, and others. Some of the FDA warning letters also cite the companies involved for quality issues related to product sterility.
The agency issued warning letters to the following companies: Boiron Inc., CVS Health, DR Vitamin Solutions, Natural Ophthalmics Inc., OcluMed LLC , Similasan AG/Similasan USA, TRP Company Inc., and Walgreens Boots Alliance Inc. Consumers currently using eye products included in these warning letters should speak to their health care professional. The FDA encourages consumers and health care professionals to report any adverse reaction to the agency’s MedWatch program at bit.ly/FDAMedWatch .
The FDA has asked the companies to respond within 15 days of receipt of the letters, stating how they will correct the violations. Failure to correct the violations promptly may result in the FDA pursuing legal action, including product seizure and/or a court order requiring a company to stop manufacturing and distributing an unapproved product. Additionally, the agency has placed some of these companies on import alert (www.accessdata.fda.gov/cms_ia/importalert_189.html ) to help stop their products from entering the U.S. and reaching consumers.
The FDA’s investigation of eye products is ongoing, and the agency may take additional regulatory or enforcement actions, as warranted.
SYMPOSIUM SPOTLIGHT: EARLY BIRD REGISTRATION ENDS NOV. 17
• THE GLOBAL SPECIALTY LENS SYMPOSIUM (GSLS) is the leading global contact lens conference with delegates attending from dozens of countries. The four-day conference—being held from Jan. 17-20, 2024, in Las Vegas—focuses on the successful management of ocular conditions using today’s specialty contact lenses through interactive educational platforms including expert panel discussions, breakout lecture sessions, and clinical workshops. Register by Nov. 17 for early bird rates at GSLSymposium.com .
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