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In 2 weeks, the study participant's dry eye symptoms improved from 76 to 43 on a 0-100 rating scale, according to Marc-Matthias Schulze, PhD, Dipl Ing.

Does lifitegrast improve dry eye symptoms for contact lens wearers?

-In the midst of its contentious merger offer from Novartis, Alcon Inc. announced it will acquire the rights to three products from Tampa, FL-based Sirion Therapeutics Inc. 

On Jan. 18, Alcon said it would acquire the U.S. rights to two FDA-approved products-difluprednate ophthalmic emulsion (Durezol) 0.05%, an ophthalmic corticosteroid in drop form for the treatment of inflammation and pain associated with eye surgery, and ganciclovir ophthalmic gel 0.15% (Zirgan), which the FDA approved on Sept. 17 for treating acute herpetic keratitis. In April 2007, the FDA had granted the gel orphan drug status. 

The acquisition also gives Alcon nearly global rights, excluding Latin America, to cyclosporine (Zyclorin), an investigational drug being developed to treat dry eye and other ocular surface diseases. The deal is expected to close by the end of Q1 2010, and hinges on customary closing conditions and required regulatory approvals. 

"While the potential Novartis deal is certainly an issue for us, our leadership is focused more on continuing to build Alcon's commercial capabilities and research pipeline," MacHatton said. "The Sirion deal is a good example of that, as it brings a currently marketed product in Durezol, the recently approved orphan drug Zirgan that will be launched soon, and a potential dry-eye treatment for our pipeline." 

MacHatton declined to say the cost of the acquisitions. 

Sirion spokeswoman Erin Parsons said the deal is "totally separate" from Alcon's discussions with Novartis. "We are certain this will not affect the completion of the deal between Alcon and Sirion," she said. 

In the midst of the contentious merger offer from Novartis, Alcon Inc. announced it will acquire the rights to three products from Tampa, FL.-based Sirion Therapeutics Inc.

Alcon acquires rights to three Sirion products

A large international study conducted by the LHON Study Group reported that a unilaterally administered gene therapy to treat Leber hereditary optic neuropathy (LHON) caused by the 

gene variant resulted in bilateral improvement in visual acuity with improved quality of life and good overall tolerability up to 5 years after treatment.

The first study author, Patrick Yu-Wai-Man, MD, PhD, and colleagues commented, “These results demonstrated the persistent benefit over time from 1 dose of lenadogene nolparvovec (rAAV2/2-ND4, Lumevoq, GenSight Biologics SA), which is promising for the use of gene therapy in LHON due to the 

gene variant,” the most common cause of LHON.

Yu-Wai-Man is from the Cambridge Centre for Brain Repair and MRC Mitochondrial Biology Unit, Department of Clinical Neurosciences, University of Cambridge, and the Cambridge Eye Unit, Addenbrooke’s Hospital, Cambridge University Hospitals, both in Cambridge, United Kingdom; and Moorfields Eye Hospital, and the Institute of Ophthalmology, University College London, both London.

LHON, a genetic disease that affects the retinal ganglion cells,

results in severe bilateral sequential vision loss.

The investigators explained, “Lenadogene nolparvovec, an adeno-associated virus (AAV)–based ocular gene therapy, was developed to treat patients carrying the m.11778G>A mitochondrial DNA gene variant. Its efficacy and safety have been evaluated in four clinical studies that showed an improvement in best-corrected visual acuity (BCVA) up to 2 years after administration and a good safety profile.

The multinational, multicenter, prospective RESTORE Study is the 5-year follow-up study of the phase 3 clinical RESCUE and REVERSE Studies of lenadogene nolparvovec to treat vision loss from LHON due to the 

 mutation. The RESCUE Study evaluated the treatment up to 6 months after the onset of LHON

 and the REVERSE Study did the same from 7 months to 1 year.

In the RESCUE and REVERSE Studies, the patients were treated with a intravitreous injection in 1 eye and a sham injection in the other eye. The main outcome measures were the best-corrected visual acuity (BCVA), quality of life using the National Eye Institute visual functioning questionnaire 25, and adverse events.

The RESTORE Study included 62 of 76 patients who were included in the RESCUE ad REVERSE Studies; 55 patients completed the 5-year examination. The investigators reported that the patients “sustained bilateral improvement in visual acuity with improved quality of life and good overall tolerability up to 5 years after unilateral lenadogene nolparvovec intravitreal administration in patients with LHON due to the 

The investigators concluded, “In this analysis of the RESTORE trial, the follow-up of patients with LHON due to the 

 gene variant unilaterally treated with lenadogene nolparvovec demonstrated a sustained bilateral improvement in BCVA and a good safety profile up to 5 years after treatment. This evidence of persistent benefit over time is promising for the use of gene therapy in these patients.”

Yu-Wai-Man P, Newman NJ, Biousse V, et al. Five-year outcomes of lenadogene nolparvovec gene therapy in LHON. 

Published online December 19, 2024. doi:10.1001/jamaophthalmol.2024.5375

Yu-Wai-Man P, Griffiths PG, Chinnery PF. Mitochondrial optic neuropathies—disease mechanisms and therapeutic strategies. 

Vignal-Clermont C, Girmens JF, Audo I, et al. Safety of intravitreal gene therapy for treatment of subjects with Leber hereditary optic neuropathy due to mutations in the mitochondrial ND4 gene: the REVEAL study. 

Newman NJ, Yu-Wai-Man P, Carelli V, et al.; LHON Study Group. Efficacy and safety of intravitreal gene therapy for Leber hereditary optic neuropathy treated within 6 Months of disease onset. 

Yu-Wai-Man P, Newman NJ, Carelli V, et al. Bilateral visual improvement with unilateral gene therapy injection for Leber hereditary optic neuropathy. 

Newman NJ, Yu-Wai-Man P, Subramanian PS, et al.; LHON REFLECT Study Group. Randomized trial of bilateral gene therapy injection for m.11778G>A MT-ND4 Leber optic neuropathy. 

RESTORE study: Unilateral genetic treatment for LHON with positive bilateral results

Dry eye can have debilitating effects on a patient’s vision and their life, depending on how bad the anterior segment problem gets. As optometrists, we can and should be on the front lines of providing not only vision exams and correction but also vision care. It is emotionally rewarding as well as beneficial for the practice and patients.

In 2017, 2 huge reports made me excited about ocular surface treatment: One was the TFOS DEWS II (Tear Film & Ocular Surface Society Dry Eye Workshop II) report, and the other was CEDARS.2, published by the Cornea External Disease and Refractive Society. These reports were the catalyst for me to incorporate dry eye treatment into my practice. Although it took about 2 years to implement it effectively, it was so successful that we opened a whole new facility focusing solely on dry eye treatment.

Three steps to integrating dry eye therapy

We implemented dry eye treatment in phases. Here are my top 3 tips for successfully implementing dry eye treatment into a practice.

1. Ask the right questions and do a screening survey.

These can include the Ocular Surface Disease Index or Standard Patient Evaluation of Eye Dryness questionnaire, which are easy to use and implement in your practice. Patients may not know what dry eyes feel like, so it is best not to ask, “Do your eyes ever feel dry?” because it requires a simple yes or no answer and is ineffective as a conversation starter. Instead, start by discussing the patient’s lifestyle to identify any visual habits that may put them at risk for dry eye. For example, patients who are computer engineers and spend 12 to
15 hours a day on digital devices are at risk for not only dry eye but also eye strain and other visual effects. They may be asymptomatic or believe any irritation or varied vision is due to eye strain when it may be treatable dry eye.

2. Take images—they are worth a thousand words.

We have many imaging options that enable patients to see what is happening with their eyes. For example, fluorescein dye creates a cool neon effect that shows where surface damage is occurring from dry eyes––a powerful image to show the patient. You can demonstrate how quickly it takes for the tears to disappear. This can help the patient connect what they are physically feeling to the diagnosis of dry eye.

3. Understand the different treatment levels for different severities.

Using certain over-the-counter products is a great place to start, as this can help patients develop a routine of putting in drops, keeping their eyes clean, or taking a vitamin supplement. There are many superb pharmaceutical options and also more procedure options available now. Knowing what each option does for each patient based on their dry eye diagnosis is vital to developing effective treatment.

When treating meibomian gland dysfunction (MGD) specifically, there are 3 main areas to target: inflammation, obstruction, and production. Different devices can help fight problems with all 3. For example, intense pulsed light is becoming popular for dry eye and MGD treatment. It has an anti-inflammatory effect that uses light waves to target tissues and calm inflammation so that the glands and surrounding structures can work better. To remove blockages and obstruction, we have blepharo exfoliative treatments for surface eyelid issues to remove biofilm and bacteria from around the eyelid edges. Low-level light therapy, also known as photobiomodulation, helps stimulate cellular activity to effectively have tissues make more of the critical components of our tears. Radio frequency is starting to come into play, which tightens the skin and builds collagen. If the collagen and skin are tighter around the eyes, it allows for a better mechanical blink with more compression, which results in better expression and more tears.

Make it easy for patients to accept your treatment plan

All these procedures and technology are beneficial to patients when they are accessible. Some of the procedures for dry eye are covered by different medical insurances, and some are not. In our practice, we package treatments and offer a percentage discount for bundled items. We also accept, in addition to typical credit cards, the CareCredit health and wellness credit card, which enables patients to pay over time, often with promotional financing.

Finally, my best advice is not to hesitate. You are the front line for patients in all things regarding eye care and correction. Once they know you have treatment options available, you will find that dry eye will become a thriving portion of your practice.

Adding a service to your practice can be scaled to your liking.

A beginner’s guide to dry eye treatment integration

EnVision Summit Co-chairs Sherrol Reynolds, OD, FAAO; Katie Rachon, OD, FAAO, Dipl ABO; Jessica Steen, OD, FAAO, Dipl ABO; and Cecelia Koetting, OD, FAAO, Dipl ABO; express excitement for the upcoming conference and why optometrists should attend.

EnVision Summit 2025: Meet the chairs

As the optometry track of the EnVision Summit expands in 2025, so does attendee excitement for the conference, to be held from February 14-17 in Puerto Rico. Conference optometry faculty Sherrol Reynolds, OD, FAAO; Katie Rachon, OD, FAAO, Dipl ABO; Jessica Steen, OD, FAAO, Dipl ABO; and Cecelia Koetting, OD, FAAO, Dipl ABO; share what they find makes EnVision special and what they plan to take part in during the conference.

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

Hello. My name is Dr Sherrol Reynolds, and I am a professor at Nova Southeastern University College of Optometry in Fort Lauderdale, Florida. I look forward to this year's EnVision Summit. It's going to be again in Puerto Rico. The dates are February 14 through the 17th, and it'll be in San Juan, Puerto Rico. And I have been invited again to present on the latest information when it comes to retina, new treatment when it comes to geographic atrophy, also talking about the latest research in retina, the latest update, the latest treatment modalities for our patients with retinal conditions, and to also be on panels with acclaimed experts and retinal specialists. I look forward to seeing you there.

Hi. I'm Katie Rachon. I'm an optometrist at Virginia Eye Consultants in Norfolk, Virginia. We are a tertiary care, OD/MD medical only center. I am currently the residency director there for 2 residents. And I'm excited to be a speaker at the EnVision conference and attending the conference this year, because last year we had an amazing time, and the optometry track, we learned from a wide variety of colleagues from different settings. We learned from a lot of ophthalmologists that joined us during our track, so we could hear a lot about comanagement. And of course, this is all in a beautiful setting in Puerto Rico over the weekend. So I'm really excited to join again as a speaker and as an attendee, and I hope to see you there.

I'm looking forward to EnVision in 2025 to connect with colleagues, with optometrists, with ophthalmologists, with high level education in a panel format, and to really engage our full community, our family members, our colleagues' children, in a really unique and special environment.

I'm excited that we are getting to do this again this year, and hopefully maybe some more of our optometry friends will learn about the conference and come join us, not just for the optometry track. I mean, it's really encouraged that we're all at the same meeting, and if you want to go sit in on a session that's going on over on the ophthalmology track that interests you go over there as well, and vice versa.

EnVision Summit optometry faculty Sherrol Reynolds, OD, FAAO; Katie Rachon, OD, FAAO, Dipl ABO; Jessica Steen, OD, FAAO, Dipl ABO; and Cecelia Koetting, OD, FAAO, Dipl ABO; express excitement for the upcoming conference and why optometrists should attend.

Conference

EnVision Summit 2025: Meet the faculty

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.

is the president of Omni Eye Specialists, headquartered in Wilmington, North Carolina, and a founding partner of Keplr Vision. Schmidt is president of the Optometric Glaucoma Society and was recently named one of the Top 250 Innovators in Optometry by 

. He is an adjunct professor at various schools of optometry and is a frequent contributor to optometric journals. He is the author of 

Lids and Nasolacrimal System: Clinical Procedures

 and lectures internationally on glaucoma and other ocular diseases.

In the past 24 months Schmidt has received honoraria or compensation from the following companies as an advisor of speaker: Allergan, Bausch & Lomb, Lumenis, Sydnexis, Topcon, Thea Pharmaceuticals, Eyenovia, Sight Science, Harrow, M&S Technologies, Carl Zeiss

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

This quiz accompanies THIS article from our December issue

c. One-third eye width, canthus to canthus

d. One-third eye fissure opening vertically

Marc-Matthias Schulze, PhD, Dipl Ing

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