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| Vol. 24, #7 • Monday, February 13, 2023 |
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Off the Cuff: Artificial Tears Recall
Last week the US FDA announced the “voluntary” recall of artificial tears manufactured by Global Pharma Healthcare of Chennai, India (EzriCare and Delsam Pharma—largely available from Walmart and Amazon), after reports of drug-resistant Pseudomonas aeruginosa contamination. At the time of the notification, there were 55 infected individuals, 5 with vision loss, and 1 death from bloodstream infection. These infections occurred in 12 states across the entire US, with the death occurring in Washington state. The FDA placed an import alert/stoppage on all products manufactured by Global Pharma Healthcare due to "providing an inadequate response to a records request and for not complying with Current Good Manufacturing Practice (CGMP) requirements." The CGMP violations included lack of appropriate microbial testing, formulation issues, and lack of controls for tamper-evident packaging found at their manufacturing facility in Thiruporur, India.
Both of the artificial tears that were recalled were bottled multi-dose, preservative-free carboxymethylcellulose-based artificial tears. I couldn’t find any information to see if Global Pharma used those flat-topped valve-tipped bottle designs you see used for PF multi-dose drops. In the lay press, I read individuals questioning the safety of all preservative-free multi-dose tears and recommending the use of unit dose artificial tears. Honestly though, where’s the logic in that? If the product is contaminated at a manufacturing level, it would be contaminated within a unit dose vial as well.
So what have we learned? If you find yourself dealing with a non-responsive infection and the patient says they’ve only been using artificial tears, that now requires even more delving as to where they acquired it, exact brand, whether they are preservative free, how old…. Preservative-free medications and artificial tears have been used safely for years and are central to dry eye management. They weren’t the problem. Unfortunately, this whole situation becomes a cautionary tale and underscores the importance of recommending tried-and-true branded products over allowing patients to be exposed to potentially harmful discounted third-party knockoffs.
Want to share your perspective?
Write to Dr. Shannon L. Steinhäuser, OD, MS, FAAO at ssteinhauser@gmail.com.
The views expressed in this editorial are solely those of the author and do not necessarily represent the opinions of Jobson Medical Information LLC (JMI), or any other entities or individuals.
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Intense Pulsed Light Attenuates Oxidative Stress in Perennial Allergic Conjunctivitis
The objective of this study was to assess the effects of intense pulsed light (IPL) on
oxidative stress (OS) in perennial allergic conjunctivitis (PAC). IPL treatment has been proven effective for dry eye disease (DED). However, the authors note that it has been observed that after IPL treatment, some patients with DED combined with allergic conjunctivitis (AC) not only show an improvement in eye dryness, but also their AC-related eye itching is relieved. The mechanism by which IPL inhibits allergic reactions is not clear. In this small study, five patients with moderate-to-severe PAC were given two IPL treatments on the periorbital skin with a 2-week interval. Visual analog scale (VAS) scores and signs of AC, including eye redness and conjunctival follicles, were assessed before the first treatment (day 1) and 2 weeks after the second treatment (day 30). Tears were also collected at the same time, and lipid oxidation (LPO) metabolite analysis was performed using liquid chromatography tandem mass spectrometry (LC-MS/MS) to investigate the effects of IPL on OS response.
The results of this study show that the average VAS score significantly decreased with
treatment (30.2 for day 1, 10.6 for day 30). The general signs of PAC showed no
difference. LPO metabolite analysis revealed that 17,18-diHETE, which is an oxidation
product of eicosapentaenoic acid, and 13-OXoODE, which is an oxidation product of
linoleic acid are significantly downregulated after IPL treatment.
This study concluded that the photothermal effect of IPL attenuates OS in PAC, and this
seems to be one of the mechanisms by which IPL treatment improves PAC.
SOURCE: Li D, Lu J, Hu Z, et al. Intense pulsed light attenuates oxidative stress in perennial allergic conjunctivitis. Photobiomodul Photomed Laser Surg. 2023;41(1):17-25.
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Dermatological Findings in Glaucoma Patients: Comparison Between Pseudoexfoliative and Primary Open-Angle Glaucoma
The purpose of this study was to compare the frequency of dermatological
manifestations between patients with pseudoexfoliative glaucoma and those with
primary open-angle glaucoma. A cross-sectional study was done on all consecutive
pseudoexfoliative glaucoma (PEXG) and primary open-angle glaucoma (POAG)
patients evaluated in a tertiary eye hospital during the study period. Eligible patients
were referred to the dermatology department for complete skin, hair, nail, and mucosal
examinations.
Twenty-one patients in the PEXG group and 26 patients in the POAG group were included in this study. The most common skin manifestations in the study were seborrheic dermatitis, dry skin, and cherry angioma. The frequency of lentigines (benign lesions that occur on the sun-exposed areas of the body) was significantly higher in the PEXG patients than in the POAG group. More than half of the study population had seborrheic dermatitis (57.1% and 61.5% in the PEXG and POAG groups, respectively); however, the difference between the groups was not statistically significant. Similarly, the frequencies of skin dryness, cherry angioma, nevus, psoriasis, contact dermatitis, itching, seborrheic keratoses, notalgia paresthetica, and vitiligo in the two groups were not statistically significantly different. There was no significant association between the frequency of the investigated skin manifestations and patients, age, visual acuity, intraocular pressure, and cup-to-disc ratio.
The researchers noted that integumentary system disorders are pervasive in glaucoma
patients and suggest that dermatologic evaluations in glaucoma patients should be
considered for diagnostic and therapeutic purposes.
SOURCE: Ahmadpour F, Nahidi Y, Daneshvar R. Dermatological findings in glaucoma patients: comparison between pseudoexfoliative and primary open-angle glaucoma. J Ophthalmic Vis Res. 2022;17(4):479-85.
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Vision Rehabilitation in Glaucoma Patients
Vision rehabilitation services are important but underutilized resources for patients with
glaucoma. Glaucoma and its impact on vision can affect patients’ abilities to read and drive, two activities of daily living that are associated with quality of life and functional
independence. The purpose of this review was to provide an overview of low vision,
discuss barriers to vision rehabilitation, and outline various strategies and interventions
to optimize visual function and quality of life in patients with glaucoma.
Recent studies have shown that glaucoma negatively impacts reading, driving and
overall quality of life. Decreased visual acuity, visual field loss and reduced contrast
sensitivity play a role. Low vision services and interventions can help patients maximize
visual function and improve their quality of life. Barriers to receiving these services exist
at multiple levels and an increased awareness and integration into routine ophthalmic
care are needed to deliver comprehensive care.
The authors wrote that glaucoma is one of the leading causes of low vision. Eye care providers
who treat glaucoma often tend to focus on objective measures to monitor progression
and disease severity, but the functional impact of glaucoma should also be addressed, they added. Furthermore, low vision services can benefit patients, particularly for reading and driving, and should be considered as an essential component of patient care.
SOURCE: Shi A, Salim S. Vision rehabilitation in glaucoma patients. Curr Opin Ophthalmol. 2023 Jan 14. Epub ahead of print. PMID: 36718681.
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Industry News
FDA Accepts Aldeyra's NDA for Reproxalap
Aldeyra Therapeutics announced the FDA accepted the New Drug Application for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease. The FDA assigned a Prescription Drug User Fee Act date of November 23. Learn more.
New B+L Social Media Campaign for AMD Patients
Bausch + Lomb Corporation announced a social media campaign, “What Sight Inspires You,” designed to raise awareness of age-related macular degeneration. The campaign features personal stories from Bausch + Lomb’s SightMatters community, an online educational resource designed for people living with AMD, and educational content on AMD. The campaign will run on the SightMatters Facebook page throughout the month of February. View the page.
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Journal Reviews Editor:
Katherine M. Mastrota, MS, OD, EMBA, FAAO
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