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The important role of the optometrist and legal responsibilities

Eye injuries outside the workplace: the OD's important role and legal responsibilities

This quiz accompanies THIS article from our December issue

c. One-third eye width, canthus to canthus

d. One-third eye fissure opening vertically

Quiz: Know the ocular effects of eyelash growth serums

Semifluorinated alkanes (SFAs) seem to be all the rage since the launch of perfluorohexyloctane (PFHO) (Miebo; Bausch+Lomb) and cyclosporine 0.1% dissolved in perfluorobutylpentane (PFBP) (Vevye; Harrow). Both are indicated to treat the signs and symptoms of 

 (DED)—contrary to popular belief, there are no FDA-approved products with an indication for evaporative dry eye disease or meibomian gland dysfunction (MGD). Many of us have gladly adopted these two SFA-containing drops into our armamentarium of dry eye treatments and happily received whatever story the sales representative wants to tell us. The current DED treatment landscape is very crowded, and there is not 1 magic bullet that works for all our patients with DED. As doctors, we are continually searching for better treatment options for DED. This article aims to dive deeper into the preclinical and clinical studies around some of the science of these SFAs and help us better understand how SFAs work in the eyes of our patients seeking relief. 

SFAs are not a new development in the ophthalmic space. They have been used for decades in retinal surgeries. PFHO has been available as an over-the-counter artificial tear in Europe, Australia, and New Zealand since 2015 under trade names such as EvoTears, NovaTears, and Optase, among others, establishing a safety record. Much of the science for both PFHO and PFBP is buried within preclinical studies. I will quickly summarize findings from various studies used in the clinical claims we regularly hear today in hopes of clearing up muddy waters around these drops.

Vittitow et al evaluated PFHO to distinguish the evaporation rate of buffered saline vs harvested human meibum in an in vitro setting.

 The rate of evaporation was measured gravimetrically (weight based). The researchers found almost a 4 times difference in evaporation favoring PFHO vs meibum alone. Although these findings are statistically significant, investigators point out major study design concerns in the discussion section: “A major finding of the current study…in relative agreement with yet other studies that show that, in vitro, meibum lipid does not inhibit evaporation of saline significantly.” Furthermore, “PFHO on evaporation was not measured in vivo, in an environment where blinking and tear film composition is more complex.” The investigators point out that the control group does not mimic real-world dynamics, as harvest meibum does not inhibit evaporation well.

Agarwal et al evaluated the clearance rates of both SFAs in an ex vivo pig eye model. Evaporation was again measured gravimetrically, in a controlled environment that did not simulate tear turnover or blink shear rates; researchers found that 50% of PFBP had evaporated within 0.5 hours and 100% had gone within 2 hours.

 More than 50% of PFHO was still unevaporated at 24 hours. This model was repeated using a perfusion chamber to simulate tear turnover at 1 hour and found similar but less dramatic results. PFBP’s clearance rate vs cyclosporine 0.05% ophthalmic emulsion (Restasis; Abbvie) was 5.1 times slower, whereas PFHO’s clearance rate vs 0.05% cyclosporine was 11 times slower.

Spencer et al evaluated radiolabeled PFHO in an ex vivo model and found that PFHO was detectable in tears for up to 6 hours.

 In a separate study, Spencer et al evaluated radiolabeled PFBP and found that PFBP was detectable in tears for up to 8 hours.

Agarwal et al evaluated ocular surface tear dynamics in an in vivo animal model using live rabbits. Investigators found that both SFAs improved lipid layer grading (LLG) immediately upon instillation of a single drop while decreasing in the saline arm.

 In repeated dosing over 7 days, PFHO did see statistical significance starting at day 5 vs baseline in LLG improvement. However, the study did not show a statistically significant improvement in tear evaporation rate, tear volume, or osmolarity from baseline for either SFA or between SFAs. In a post-hoc analysis by the investigator, PFBP also showed a statistically significant improvement in LLG with no statistically significant difference vs PFHO.

Cyclosporine’s dose-ranging phase 2 study (NCT02617667), conducted by Wirta et al, included a PFBP vehicle arm, PFBP+0.05% cyclosporine, PFBP+0.1% cyclosporine, and cyclosporine 0.05% ophthalmic emulsion.

 Primary efficacy end points evaluated change from baseline in total corneal fluorescein staining (tCFS) and visual analog scale (VAS) dryness at days 15, 29, 85, and 113. PFBP alone showed no statistically significant difference in reduction in tCFS vs 0.05% cyclosporine ophthalmic emulsion, with results numerically favoring PFBP at all measured time points. There were also no statistically significant findings for PFBP in symptom differences vs 0.05% cyclosporine.

Sheppard et al and Tauber et al evaluated PFHO vs saline as PFHO’s pivotal phase 3 studies and found PFHO demonstrated statistically significant improvement in tCFS and VAS dryness scores over 8 weeks vs saline.

 The study enrolled patients with a history of MGD and low tear film breakup time (TFBUT); however, TFBUT results were not reported after 8 weeks of treatment. Perhaps the lack of TFBUT data led to PFHO’s mechanism of action on the package insert as follows: “PFHO forms a monolayer at the air-liquid interface of the tear film [that] can be expected to reduce evaporation. The exact mechanism of PFHO in DED is not known.”

In summary of these findings, do SFAs work in DED? Doctors and patients seem to think so, and the data seem to support it. Do SFAs demonstrate an entirely new mechanism of action for treating DED? That is unclear. Neither SFA showed improvement in tear evaporation rates nor osmolarity in preclinical studies. Although many anecdotal reports show improvement in clinical markers, no well-controlled clinical studies have demonstrated improvement in TFBUT, osmolarity, meibography, meibomian expression, or any measures of MGD or evaporative DED. Finally, the preclinical study evaluating PFHO vs harvested human meibum was not conducted in an ideal environment mimicking a real-world environment. Do our patients really care about mechanism of action? I do not believe so. If they are feeling better, the mechanism of action is irrelevant.

Vittitow J, Kissling R, DeCory H, Borchman D. In vitro inhibition of evaporation with perfluorohexyloctane, an eye drop for dry eye disease. 

 2023;98:100704. doi:10.1016/j.curtheres.2023.100704

Agarwal P, Scherer D, Günther B, Rupenthal ID. Semifluorinated alkane based systems for enhanced corneal penetration of poorly soluble drugs. 

. 2018;538(1-2):119-129. doi:10.1016/j.ijpharm.2018.01.019

Krösser S, Spencer E, Grillenberger R, Struble CB, Fischer K. Ocular and systemic distribution of 14C- perfluorohexyloctane following topical ocular administration to rabbits. I

Krösser S, Korward J, Tauber J. Pharmacokinetics and distribution of perfluoroputylpentane, a novel eye drop vehicle, in rabbits after topical administration. Presented at: Tear Film and Ocular Surface Society Congress; October 30-November 2, 2024; Venice, Italy.

Agarwal P, Khun D, Krösser S, et al. Preclinical studies evaluating the effect of semifluorinated alkanes on ocular surface and tear fluid dynamics

. 2019;17(2):241-249. doi:10.1016/j.jtos.2019.02.010

Wirta DL, Torkildsen GL, Moreira HR, et al. A clinical phase II study to assess efficacy, safety, and tolerability of waterfree cyclosporine formulation for treatment of dry eye disease. 

 2019;126(6):792-800. doi:10.1016/j.ophtha.2019.01.024

Sheppard JD, Kurata F, Epitropoulos AT, Krösser S, Vittitow JL; MOJAVE Study Group. NOV03 for signs and symptoms of dry eye disease associated with meibomian gland dysfunction: the randomized phase 3 MOJAVE study. 

. 2023;252:265-274. doi:10.1016/j.ajo.2023.03.008

Tauber J, Berdy GJ, Wirta DL, Krösser S, Vittitow JL; GOBI Study Group. NOV03 for dry eye disease associated with meibomian gland dysfunction: results of the randomized phase 3 GOBI study. 

. 2023;130(5):516-524. doi:10.1016/j.ophtha.2022.12.021

What we know and what we do not know…yet.

Semifluorinated alkanes in dry eye disease

2024 has kept retina specialists busy. With new treatments hitting the markets and age-related macular degeneration (AMD) prevalence rising, it is more important than ever for optometrists to do their part to identify and refer patients in need of therapy. Plus, early detection and diagnosis can make a world of a difference in preserving vision.

This year, optometrists have been working to find ways to streamline their care for patients with geographic atrophy (GA). Among a sea of information and advice, the

team has compiled some of the top GA stories of 2024 to simplify your search and help ring in 2025.

Coupling of clinical trial recruitment and AI eases the burden of GA studies

Artificial intelligence (AI) is finding its niche in medical research, with more and more applications being explored. A team of researchers in the United Kingdom (UK) are exploring AI to simplify appropriate patient recruitment in trials focused on geographic atrophy (GA) associated with age-related macular degeneration (AMD).

First authors and PhD candidates Dominic J. Williamson and Robbert R. Struyven point out that developing new treatments is expensive, can take decades, and relies heavily on data from clinical trials to demonstrate the safety and efficacy of the new treatments. “Today, challenges in recruiting participants stand as a significant obstacle in clinical trials.Time taken to fully recruit a trial adds significantly to the cost and can lead to delays, with up to 86% of trials not finishing on schedule,”

 the researchers write. Williamson and Struyven are from the National Institute for Health and Care Research Biomedical Research Centre for Ophthalmology at Moorfields Eye Hospital National Health Service Foundation Trust in London, UK, and the Centre for Medical Imaging Computing at University College London.

Contemporary care in GA: Practice patterns are evolving

With newly available treatment options for slowing the progression of geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD), optometrists have an essential role to play in ensuring appropriate patients receive timely care. Although optimal patient selection and therapeutic best practices continue to evolve, what is certain is that early identification is the key to preserving visual function. With timely treatment, we can help patients see for as long as possible.

Consensus guidelines on GA diagnosis and management

With the current focus on stopping the progression to geographic atrophy (GA) associated with 

 (AMD), physicians and researchers are fine-tuning the identification of the various disease stages, management scenarios, and treatment considerations for this patient population.

Carl Regillo, MD, from Mid Atlantic Retina, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, was the first author of a report issued by an expert panel of optometrists, comprehensive ophthalmologists, and retina specialists, and published in 

Infrared imaging is an aid for patient education about GA

 Case of the Quarter series, Katherine Talcott, MD, shares 2 cases of geographic atrophy (GA) and highlights the importance of multimodal imaging to diagnose and monitor GA progression. Talcott is an assistant professor of ophthalmology at the Cole Eye Institute at Cleveland Clinic Lerner College of Medicine in Ohio.

Inflammasome Therapeutics announces first patient dosed in Phase 1 trial evaluating Kamuvudine-8 treatment in patients with GA

Inflammasome Therapeutics announced its first patient has been dosed in the company’s first-in-class clinical trial for dry age-related macular degeneration (AMD).

 The non-randomized, open label, safety and efficacy study will evaluate Kamuvudine-8 (K8) for the treatment of patients with geographic atrophy (GA).

“This marks the second trial underway with our Kamuvudines in ophthalmology,” said Paul Ashton, PhD, president and CEO of Inflammasome Therapeutics, in the release.

Brush up your geographic atrophy knowledge with our 2024 content highlights.

2024 in the rearview: The top GA takeaways

Tiffany Tsoi, OD, FAAO, has always been a video game enthusiast, and when she began optometry school, she began to wonder about how best to care for the eyes in an eSports environment. Now a vision rehabilitation resident, Dr. Tsoi shares some of the details about her research on increasing visual comfort and improving visual performance for athletes.

Prefer to listen on the go? You can follow the podcast on 

Follow Dr Korik on social media:
Instagram: 

https://www.linkedin.com/in/miriam-korik-81b492111/

https://www.youtube.com/channel/UCuIVJVZ17AJFEo8fqXK_gZg

Tiffany Tsoi, OD, FAAO, shares insights on the world of visual training research for eSports athletes.

You and Eye: Vision training research in eSports - with Tiffany Tsoi, OD, FAAO

MediPrint Ophthalmics announced results from the company’s phase 2b clinical trial of LL-BMT1 at this year’s 

LL-BMT1 is a novel, preservative-free, weekly drug-eluting 

 created by the company’s proprietary 3D printing technology, that delivers a sustained dose of bimatoprost and hyaluronic acid for the treatment of 

. According to the company, the phase 2b clinical trial met all primary end points with no serious adverse events reported in either cohort.

In the study, the 32-µg dose of LL-BMT1 achieved equivalence to the efficacy of bimatoprost 0.01% in reduction of intraocular pressure (IOP). Furthermore, the company noted that patients with LL-BMT1 only required 6 lens insertions over the course of 3 weeks. This was an 86% reduction in treatment frequency compared to traditional daily eye drops.

The hyaluronic acid delivered by LL-BMT1 also allowed for a “significantly improved patient-reported comfort and relief from dry eye symptoms.” Patients in the chosen dose range, reported a 38% improvement in comfort as well as a 40% improvement in dry eye symptoms.

Ian Ben Gaddie, OD, FAAO, who presented the results at the AAOpt meeting stated, “LL-BMT1 represents a potential major step forward in glaucoma care, offering an effective, less burdensome alternative to daily eye drops and a less invasive option to laser or surgical modalities.”

The company stated that thanks to the results of the phase 2b study,

 MediPrint plans to move forward with two programs in 2025. Programs will include focusing on comfort improvement, with hyaluronic acid in the daily disposable lens market as well as initiating the phase 3 clinical study of LL-BMT1 for glaucoma.

MediPrint Ophthalmics Presents Promising Results from Phase 2b Clinical Trial of LL-BMT1 for Glaucoma at American Academy of Optometry. Press Release; November 12, 2024. Accessed November 12, 2024. 

https://www.businesswire.com/news/home/20241112595525/en/MediPrint-Ophthalmics-Presents-Promising-Results-from-Phase-2b-Clinical-Trial-of-LL-BMT1-for-Glaucoma-at-American-Academy-of-Optometry

The weekly drug-eluting contact lens was created by the company’s proprietary 3D printing technology and met all primary end points with no serious adverse events reported in either cohort.

Conference

MediPrint Ophthalmics reveals positive results from phase 2b study of LL-BMT1 contact lens

Neda Gioia, OD, CNS, FOWNS, details the positive feedback gained so far from other optometrists that have been prescribing the NutriTears supplement to their dry eye patients.

AAOpt 2024: What optometrists think so far about the NutriTears supplement

Neda Gioia, OD, CNS, FOWNS, discussed a recent study on a supplement containing vitamin D, curcumin, lutein, and zeaxanthin, which showed significant improvements in dry eye symptoms within 14 to 28 days. Key secondary outcomes, such as MMP-9 scores and corneal staining, also improved by day 28 to 56. The supplement has been well-received by optometrists and high-level practitioners, and it offers an alternative to traditional eye drops, especially for contact lens users. Gioia emphasized its potential to expand beyond optometrists to include nutritionists and other healthcare providers in addressing ocular discomfort.

Editor's note: The below transcript has been lightly edited for clarity.

Hi, I'm Dr Neda Gioia. I'm a doctor of optometry, also a certified nutrition specialist. I have my own practice, Integrative Vision in Shrewsbury, New Jersey, and I'm also the president of the Ocular Wellness and Nutrition Society.
So this poster reflects the importance of this new finding with NutriTears. It was used in a publication that we just had in Frontiers in Ophthalmology, and what it did was it showed that, using this supplement, which included vitamin D, curcumin, lutein and zeaxanthin, against a placebo, it showed that tear volume and patient reports via OSDI improved 14 to 28 days. So what's great about this study, it really showed a quick effect with a supplement, and I'm proud to present this this year at Academy. The biggest secondary outcomes were MMP9 scores, cornea and conjuctival staining, and these things were also shown to have clinical significance at day 28 up to 56. So the primary endpoints met what we not wanted, as well as some of the secondary endpoints.

So after a few months of launching this product off the shelves, a lot of optometrists have already found that their patients are very open to one, using it, because it's a new supplement that they can really kind of complement to whatever therapies they already are using, as well as starting it earlier in the dry eye diagnosis. So I think it's been great, the feedback, so far. We have some really high level doctors using this in their clinics already, and so far so good. I'm excited to see more data from those new optometrists using it.
I think what we also need to understand is sometimes our other doctors–or even non doctors, because this can be also addressed with nutritionists as well, right? So if a patient has some ocular discomfort, they can recommend an over the counter supplement as well. So I don't think it is isolated to optometrists, but I do think we add the validity for our patients, but I do think it can go into a broader spectrum of practitioners. Absolutely.

Some of the other key takeaways to this supplement, I think we have to start thinking about patients that may want other alternatives outside of drops, especially if they're contact lens users. You know, when you start really thinking about how we can use this supplement in various ways, I really think it will bring value that, you get a nice add on to your toolbox, because we really need that in dry eye approach.

Neda Gioia, OD, CNS, FOWNS, details the positive feedback gained so far from other optometrists that have been recommending the NutriTears supplement to their dry eye patients.

Mark Rosenfield, MCOptom, PhD, FAAO

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