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BRS Analytical Service, LLC, an independent contract testing laboratory, initiated the recall because of possible concerns about product quality and safety linked to the manufacturing process. An FDA audit revealed serious manufacturing violations of Current Good Manufacturing Practice.

Potentially hazardous eye care products recalled nationwide

Videos

Neda Shamie, MD; Selina McGee, OD, FAAO, Dipl ABO; and Jacob Lang, OD, FAAO; provided their insights during CIME 2025 on May 4.

CIME 2025: What you missed in presbyopia tips, tricks, and updates

Knowing the truths concerning patient adherence and history and visual field tests can make a difference in care quality.

What to keep in mind when diagnosing and treating glaucoma

Slideshows

Catch up on the top stories in optometry during the week of May 5-May 9.

Takeaways from this week in optometry: May 5 - May 9

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Epi-on cross-linking may speed visual recovery

I have spent a good part of my career focused on dry eye and ocular surface disease. I believe that I have a good grasp of current diagnostic and management strategies for patients who are clinically and symptomatically affected by alterations/dysfunction of the ocular surface.

Recently, the expertise I have gained in my career took a turn into my personal life. This year, one of my longest and best friends, Karen, was diagnosed with a cancerous lesion. The treatment plan was comprehensive and included infusion chemotherapy, surgery, and radiation.

Karen, an executive vice president in the health care space, was thorough in her research regarding her oncologist’s road map to being cancer free. Naturally, the risks, benefits, and rewards of management were weighed and acknowledged by a second opinion. In her research and in an effort to blunt some of the adverse effects of cytotoxic chemotherapy agents (most notably hair loss), Karen elected to proceed with “cold capping.” To cold cap, the patient wears a cooling cap or device on the scalp before, during, and after chemotherapy treatments. The cooling effect constricts blood vessels in the scalp, which reduces blood flow and minimizes the exposure of hair follicles to the chemotherapy drugs, and may prevent hair loss.

Well into her infusion therapy, Karen called to ask my advice for her eyes, which had become dry and irritated. These were new sensations for Karen, who had never worn contact lenses or experienced chronic eye discomfort. Of note, although Karen retained most of her hair, her eyebrows and eyelashes were lost.

Besides helping to prevent foreign bodies from entering the eye, recall that our eyelashes help direct air currents away from the ocular surface, limiting surface desiccation.

 Was the loss of Karen’s eyelashes the cause or a contributor to her dry eye concerns? Did chemotherapy precipitate something beyond the obvious?

Research demonstrates that many patients undergoing chemotherapy (for a variety of malignancies) will experience dry eye symptoms that may be related to identifiable corneal changes induced by the cytotoxic therapeutic agent.

Corneal confocal microscopy has identified that antineoplastic drugs negatively affect the corneal subbasal nerve plexus (thinner and reduced number of nerves). Additionally, corneal alterations secondary to chemotherapy, particularly microcytic-like epithelial changes induced by biological drugs and antibody-drug conjugates, are recognized as chemotherapy-induced corneal toxicity.

Renowned cancer care hospital Memorial Sloan Kettering Cancer Center in New York, New York, prepares patients undergoing certain types of chemotherapy with ocular therapy to reduce the onset or worsening of dry eye secondary to treatment. Preventive/therapeutic management to reduce ocular adverse effects of cytotoxic agents can include cooling masks or ice bags on the eye/adnexal area before, during, and after drug infusions; brimonidine drops to vasoconstrict ocular blood vessels; a topical steroid; and lubricating drops.

Adverse anterior, posterior, and other adverse ocular effects of the variety of classes of chemotherapy drugs are multiple and can manifest in epiphora, conjunctivitis, uveitis, visual field defects, cataracts, optic neuropathy, corneal erosions, and retinopathy, among other conditions.

Because this was the first time in all my years of friendship with Karen that she reported significant ocular dryness, I initiated a palliative regimen consisting of preservative‑free artificial tears, eyelid occlusion during naps and at bedtime, local ambient humidification, and protective eyewear as needed both indoors and outdoors. Since I was unable to perform an in‑office examination, I recommended that she follow up with her own optometrist to rule out any chemotherapy‑related ocular changes and keep her oncologist informed of her symptoms. Fortunately, this initial therapy carried her comfortably through the remainder of her oncology treatment.

Now that her chemotherapy has concluded, Karen’s eyelashes and eyebrows have fully regenerated and her dryness symptoms have markedly improved. It was deeply gratifying to be able to support her in this way, and I remain grateful to all the researchers and clinicians who continue to advance our treatment options for dry eye patients.

Ocular toxicity induced by chemotherapeutic agents is often underestimated. It would be a service to our patients to conduct comprehensive patient history updates to educate patients about ocular effects prior to, during, or after cancer treatment. I certainly was remiss in this regard. However, going forward, I will keep this lesson top of mind so that patients (and friends) are well-informed and prepared for ocular adverse effects of chemotherapy.

Amador GJ, Mao W, DeMercurio P, et al. Eyelashes divert airflow to protect the eye. 

. 2015;12(105):20141294. doi:10.1098/rsif.2014.1294

Ma J, Pazo EE, Zou Z, Jin F. Prevalence of symptomatic dry eye in breast cancer patients undergoing systemic adjuvant treatment: a cross-sectional study. 

. 2020;53:164-171. doi:10.1016/j.breast.2020.07.009

Cosmo E, Midena G, Parrozzani R, Midena E. Chemotherapy induced corneal changes assessed by corneal confocal microscopy: a review. 

. 2024;14(21):2399. doi:10.3390/diagnostics14212399

Stoicescu EA, Iancu RC, Popa Cherecheanu A, Iancu G. Ocular adverse effects of anti-cancer chemotherapy. 

. 2023;16(6):818-821. doi:10.25122/jml-2023-0041

When her friend began experiencing dry eye symptoms while undergoing chemotherapy, Katherine Mastrota, OD, MS, FAAO, Dipl ABO, found herself in a unique position to provide specialized advice.

What do you say when your best friend asks for dry eye advice?

Dr Luke Lindsell discusses retinal therapy and geographic atrophy at Controversies in Modern Eye Care 2025

CIME 2025: Luke Lindsell, OD, MD, on bridging innovation and practical care in retinal disease

, Luke Lindsell, OD, MD, offered a compelling perspective on how evolving therapies for 

 and improved imaging tools are reshaping 

. Now practicing at the Cincinnati Eye Institute and teaching at the University of Cincinnati, Lindsell emphasized optimism and pragmatism in how eye care professionals can collaboratively manage retinal disease.

“Having any therapy at all for GA has been exciting,” Lindsell stated, referring to the current intravitreal treatments now in clinical use. But what excites him most are the developments on the horizon: at-home therapies, gene therapy, and devices like the Valeda Light Delivery System (LumiThera), which uses photobiomodulation and shows early promise in preventing GA altogether.

Gene therapy and the quest to reduce treatment burden

With patient fatigue around frequent injections being a persistent concern, Lindsell highlighted the growing excitement around gene therapy. Although still in clinical trials, early results suggest these treatments could significantly reduce the frequency—or even eliminate the need—for repeated injections. “It’s what patients ask all the time: ‘When will I be done?’” he said.

Lindsell recommends a proactive approach to imaging for optometrists. “Most of us have an [optical coherence tomography scanner], but don’t forget about autofluorescence,” he urged. Utilizing autofluorescence alongside near-infrared imaging or red-free photography can enhance detection of subtle GA changes, particularly at the fovea, where natural hypoautofluorescence can mask early signs.

Lindsell emphasized that optometrists should feel confident in managing early to moderate stages of retinal disease, including diabetic retinopathy and macular degeneration. “Be the leaders in early retinal care,” he said. Discussions around supplements, glycemic control, and lifestyle modifications are key components of this care phase. Referral should be considered when vision is threatened or novel therapies become appropriate.

Collaboration built on respect and transparency

Above all, Lindsell championed a respectful, comanaged approach to patient care. “This patient is not mine,” he stated, reinforcing that a specialist’s role is to complement—not replace—the referring optometrist’s care. He communicates this clearly to patients and colleagues, advocating for shared decision-making and continuous communication.

Finally, he reminded ODs to set realistic expectations. Not every referral will yield a treatment option, especially in advanced disease. However, patients often benefit emotionally from a second opinion and a clearer understanding of their condition.

Lindsell discusses promising retinal therapeutics, such as at-home therapies, gene therapy, and devices like the Valeda Light Delivery System (LumiThera), which uses photobiomodulation and shows early promise in preventing geographic atrophy altogether.

Conference

Cognition Therapeutics reported top-line results for the phase 2 MAGNIFY trial of the oral medication zervimesine intended to slow lesion growth in patients with 

age-related macular degeneration (dry AMD)

. At 18 months, patients who were treated with zervimesine had 28.6% slower GA lesion growth and their lesions were 28.2% smaller than lesions in patients in the placebo group.

“To date, we have observed evidence of robust slowing of disease progression with zervimesine treatment in Phase 2 studies in Alzheimer’s disease and dementia with Lewy bodies,” Anthony O. Caggiano, MD, PhD, Cognition Therapeutics’ chief medical officer and head of research and development, said in a press release. “These results in dry AMD represent yet another indication in which zervimesine has potential to slow the progression of disease with a once-daily oral pill. Compared to current treatment options, which require regular clinic visits for intravitreal injections, an effective oral treatment that patients can take at home would be truly transformative.”

The MAGNIFY phase 2 study concluded after approximately 100 participants were enrolled, despite the trial’s intended enrollment of 246 patients. The double-masked, placebo-controlled clinical trial randomly assigned patients to be dosed with either 200 mg of once-daily oral zervimesine or placebo. Of the 100 enrolled patients, approximately two-thirds (~66 patients) completed 12 months of dosing and one-third (~33 patients) completed 18 months. Patients were evaluated for safety, tolerability, changes in GA lesion size, lesion growth rate, changes in visual acuity, and additional anatomic and visual measures.

Investigators reported that a slope analysis showed that in patients treated with zervimesine, the trajectory of GA lesion growth rate slowed by 28.6% at 18 months. Additionally, the mean lesion size was 28.2% smaller in patients treated with zervimesine compared with lesions in patients in the placebo group (

In a press release, Cognition Therapeutics said the top-line results compare favorably with published data for FDA-approved injectable complement inhibitors (Syfovre, Apellis Pharmaceuticals; Izervay, Astellas Pharma).

“Dry AMD is now the third indication in which we have shown efficacy signals with a once-daily oral drug,” Lisa Ricciardi, Cognition Therapeutics’ president and CEO, said in a press release. “We believe zervimesine has the potential to be used as a monotherapy or in combination with existing medications. This would allow physicians the flexibility to tailor treatment regimens for their patients. Importantly it would also allow patients who are not appropriate for injectables to have access to treatment. With the right partner and development plan, we believe zervimesine could be a treatment breakthrough in these large, underserved diseases.”

The company said in a press release that the voluntary conclusion of the MAGNIFY study before fulfilling its enrollment goal has allowed the company to use its resources for ongoing programs in the Alzheimer disease and dementia with Lewy bodies pipeline.

At this time, only top-line results are published. Cognition Therapeutics will publish additional data, such as safety, demographics, and visual and anatomic outcomes, at an unreported later date. Cognition indicated its intention to submit complete findings for presentation at a medical meeting later in 2025.

Cognition Therapeutics reports topline results showing oral zervimesine (CT1812) reduced lesion growth in phase 2 study in geographic atrophy. Cognition Therapeutics. Press release. May 8, 2025. Accessed May 8, 2025. 

https://ir.cogrx.com/press_releases/cognition-therapeutics-reports-topline-results-showing-oral-zervimesine-ct1812-reduced-lesion-growth-in-phase-2-study-in-geographic-atrophy/

Topline results from the MAGNIFY phase 2 clinical trial of oral zervimesine show 28.6% slower geographic atrophy lesion growth compared with placebo.

Pipeline

Oral zervimesine reduced GA lesion growth in phase 2 study from Cognition Therapeutics

Boehringer Ingelheim announced the start of the JADE and VERDANT phase 2 clinical studies to investigate the safety and efficacy of 2 candidates: BI 1584862, a potential first-in-class oral compound for the treatment of geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD)

; and BI 771716, an antibody fragment, respectively. BI 1584862 is a phospholipid modulator intended to preserve patient vision by targeting inflammation and preserving vascular function. It follows Boehringer Ingelheim’s other candidate under investigation for the treatment of GA, BI 771716, in kicking off phase 2 investigation.

 Both announcements coincided with the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting, which took place May 4 through May 8, 2025, in Salt Lake City, Utah.

“Vision loss associated with geographic atrophy profoundly affects the lives of those impacted, particularly older adults, making daily activities more difficult. The loss of independence has a significant burden for patients, caregivers and society overall. I’m excited to see that Boehringer Ingelheim is exploring treatment options aimed at reducing the treatment and visit burden for patients and their caregivers,” Karl Csaky, MD, PhD, principal investigator of the phase 2 trial and CEO and chief medical officer of the Retina Foundation of the Southwest, said in a press release. “An oral treatment could alleviate the burden of existing treatment regimens and offer the opportunity to address both eyes simultaneously in patients with [bilateral] disease.”

BI 771716, also under phase 2 investigation, is a highly specific antibody fragment that targets GA pathology through optimized penetration of the retinal layers. Boehringer says its molecular properties have to potential to achieve unprecedented efficacy.

Currently, only 2 therapeutics are FDA approved to slow the progression of GA: pegcetacoplan (Syfovre; Apellis Pharmaceuticals) and avacincaptad pegol (Izervay; Astellas Pharma). A photobiomodulation device (Valeda; LumiThera) is FDA-approved to improve visual outcomes in patients with dry AMD. Boehringer Ingelheim’s hopeful therapeutics would widen the treatment landscape further, giving eye care providers the chance to choose the treatment that is best for the patient and their lifestyle.

“At Boehringer Ingelheim, we recognize the need for treatments that address the diverse needs of GA patients and of the medical community. Our commitment is reflected in our Phase II clinical trials investigating two distinct compounds, BI 1584862 and BI 771716, each targeting different pathways. This approach highlights our dedication to providing tailored solutions that support the individual needs of people living with the condition,” Patrick Bussfeld, MD, PhD, global head of medicine, eye health, at Boehringer Ingelheim, said in a press release. “By exploring multiple avenues, we are seeking to offer more individualized treatment options and, ultimately, improve the quality of life for people living with geographic atrophy."

In April 2023, Boehringer announced it was partnering with RetinAI to leverage its artificial intelligence (AI) properties in pursuit of pipeline advancement. The plan was to use RetinAI’s Discovery platform and range of AI tools to scour imaging to detect novel biomarkers and markers of disease progression as Boehringer continued research on its GA candidates.

At ARVO 2025, Boehringer presented 19 abstracts across its eye health portfolio, which aims to address unmet need for retinal conditions.

1. Boehringer Ingelheim starts Phase II study of its potential first-in-class oral compound as a treatment for geographic atrophy​. Boehringer Ingelheim. Press release. Published May 6, 2025. Accessed May 7, 2025. 

https://www.boehringer-ingelheim.com/science-innovation/human-health-innovation/phase-ii-start-oral-treatment-geographic-atrophy

2. A study to test different doses of BI 1584862 in people with a distinct form of age-related macular degeneration (AMD) called geographic atrophy. ClinicalTrials.Gov. Accessed May 7, 2025. 

https://clinicaltrials.gov/study/NCT06769048?cond=BI%201584862&rank=5

3. A study to test whether BI 771716 helps people with an advanced form of age-related macular degeneration (AMD) called geographic atrophy (VERDANT). ClinicalTrials.Gov. Accessed May 7, 2025. 

https://clinicaltrials.gov/study/NCT06722157?cond=BI%20771716&rank=1

4. Hutton D. RetinAI, Boehringer Ingelheim team up with shared vision to use AI to develop treatments for patients with geographic atrophy. 

https://www.ophthalmologytimes.com/view/retinai-boehringer-ingelheim-team-up-with-shared-vision-to-use-ai-to-develop-treatments-for-patients-with-geographic-atrophy

Boehringer Ingelheim announced that the phase 2 clinical studies will investigate a potential first-in-class oral compound and a highly specific antibody fragment for geographic atrophy.

Boehringer Ingelheim kicks off dual phase 2 clinical studies for geographic atrophy candidates

Bausch + Lomb has announced CE mark approval for its LuxLife full range of vision (IOL).

 The preloaded, non-diffractive IOL utilizes Pure Refractive Optics (PRO) technology in order to provide continuous vision for the entire optical diameter and from distance to near, according to a news release.

The company stated in the release that the announcement “reinforces Bausch + Lomb’s commitment to equip cataract surgeons with choices to fit the right lens to the right patient following the recent launches of enVista Envy full range of vision lenses in the United States and Canada and enVista Aspire intermediate-optimized IOLs in Europe.”

“This platform has delivered both quality of vision and patient satisfaction since its introduction,” said Luc Bonnefoy, president of surgical at Bausch + Lomb, in the release. “LuxLife is an example of how we plan to build on that success by developing premium options designed to meet the evolving needs of surgeons and patients.”

The LuxLife IOL is available in a range of cylinders spanning from +0.75D to +6.00D, which enables surgeons to treat the 79.5% of patients who have more than 0.5D of corneal astigmatism prior to their cataract surgery. Surgeons are also provided options for injection technique during implantation with LuxLife’s preloaded dual injector system.

A multicenter, comparative clinical study recently evaluated the LuxLife IOL  compared with the monofocal LuxGood IOL and found that patients experienced excellent binocular visual outcomes with LuxLife at near, intermediate, and far distances. The lens also demonstrated high patient satisfaction levels, with 95.6% reporting spectacle independence at intermediate distance and 89.5% at near.

The IOL is also equipped with 2 unique Allied Ray Technology (ART) Zones, which control and refocus light rays. According to the release, the PRO technology and ART Zones allow the lens to maintain light to the retina.

"The LuxLife lens provides truly multifocal optical performance, offering an extensive range of clear vision from distance to near,”  Francisco Javier Castro Alonso, MD, PhD, of UFR-Miguel Servet University Hospital in Zaragoza, Spain, an investigator in the multicenter clinical study, said in the release. “I consider this lens a first-choice option for patients seeking freedom from glasses at all distances.”

Bausch + Lomb expects LuxLife IOLs to be commercially available in Europe in the coming weeks, with a toric version of the lens to follow. Submissions for regulatory approvals in other countries are ongoing.

Bausch + Lomb receives European CE mark approval for preloaded LuxLife full range of vision intraocular lens. News release. Bausch + Lomb. May 7, 2025. Accessed May 8, 2025. 

https://www.bausch.com/newsroom/news/?id=260

The LuxLife full range of vision IOL is available in a range of cylinders spanning from +0.75D to +6.00D.

Bausch + Lomb's LuxLife IOL receives CE mark approval in Europe

What to know about legislative moves that have been made through May this year.

A roundup of legislative news from 2025 so far

Optometric associations, optometrists, and legislators have hit the ground running in 2025 with a flurry of legislative action. With initiatives including pay reforms, addressing vision plan abuses, and simplifying prescription verification systems, legal advocacy has already taken many forms. 

Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act

A bill signed into law in January provides physician recognition for Department of Veterans Affairs (VA) optometrists, which grants leverage to the department to increase pay awards, bonuses, and annual evaluations to VA eye care providers. With the American Optometric Association (AOA) acting as a longtime advocate for the bill, AOA President Steven Reed, OD, said the passage of the law is a critical win for all optometrists.

"This is huge, not only for the VA ODs, but for all of us," Reed said. "First of all, within the VA system, back in 2004 is when a new law was created that put physicians, the MDs and DOs, in a different pay scale. At that time, the dentists, podiatrists, and optometrists were left off. Over time, though, the dentists and podiatrists were able to be included. But even now, 20 years later, until recently, optometrists were left off. So what that did in the VA system is create some gaps because optometrists don't necessarily have a big motivation to practice in a system where they can't get paid at least comparable to what they could get in the general public. So there are a lot of holes in the system. And then to cap that off, you've got 20% of the VA optometrists at or nearing retirement, so we're about to have a big problem, because VA optometry takes care of the majority of the eye care within that system. 

"So we're very proud for them, and it's a huge win. It's very significant. But I mentioned that it's good for us too, and the reason why is that many times when we're fighting these scope battles or these 'not-a-doctor' bills, which are so prevalent, our opposition will say, 'Well, at the VA level, you guys aren't even recognized as physicians, not to mention that we are at Medicare.' They use that against us, but they can't anymore. So we just took away some of the ammunition."

VA ODs provide approximately 70% of essential primary and medical eye care services. Despite the important role optometry plays in VA health care, ODs had been on the general schedule pay scale, which was largely unchanged since 1976.

Vision/eye health care is the third-most requested service by veterans.

It is estimated that there are approximately 130,000 veterans in the United States who are legally blind and more than 1 million veterans who have low vision that causes a loss of ability to perform necessary daily activities.

As many as 64% of patients with traumatic brain injuries are estimated also to have a vision problem.

A month later, HB 3211 was introduced in Texas to address anticompetitive practices in the vision benefits market. The bill is a continuation of efforts that can be traced to June 2023, when HB 1696 was signed into law. The bill works to prevent abuses, including patient steering, doctor tiering, practice control, chargebacks, and covered services, requiring unrelated information on claims, and extrapolation in audits. 

"HB 3211 strengthens patient choice by ensuring that any properly credentialed optometrist who agrees to the [vision benefits manager's] contract terms can participate as an in-network provider—allowing Texans to see the optometrist of their choice when using their vision plan," Tommy Lucas, OD, director of advocacy at the Texas Optometric Association, said in a news release.

Other recent VBM news comes from Arkansas, with Act 142 of 2025 being signed into law in late February. Members of the Arkansas Optometric Association (ArOA) recently sat down with 

"Everything we do in optometry is legislative, and if we're to advocate for ourselves or our patients, it has to be legislative, and we're going to be the only ones that's going to do that," said Matt Jones, OD, legislative cochair at the ArOA. "So not only was the Arkansas Optometric Association behind this bill—we did this for all eye care providers across the state—but as an affiliate of the American Optometric Association, they were also advocates for this bill. And along with Matt [Burns], Joe [Sugg] and I, we worked with several AOA leaders across the country to help formulate the bill and to help talk through the bill and to make sure that we were on the right path toward advocating for better access for our patients through this VBM bill."

Unfortunately, for as long as I've practiced longer contracts and terms between doctors, these vision plans have become contracts of adhesion, where we have no ability to negotiate," said Joe Sugg, OD, legislative cochair for ArOA. "So they really give a take-it-or-leave-it type of approach, not just in the reimbursement aspect, but many other contractual aspects as well. Obviously, reimbursement is a big, big piece...if doctors don't feel that they can run their practices and get reimbursed appropriately to make a plan make sense, then, unfortunately, they're not going to accept those plans. But now, inherently in optometry, we tend to do it anyway for the good of our patients, whether it makes sense from a business standpoint or not, but not only reimbursement, but just other contractual aspects that we just continue to get squeezed. You try to negotiate these things and just have really no leg to stand on, which is ultimately why we felt something had to be done here to help our patients, ultimately, but also help doctors across the state. This bill also brings more authority for the Department of Insurance to regulate VBMs."

"Previously, it was a little limited, and this brings it under a health benefit plan, or changes that definition so it gives them the ability to regulate these companies, whereas beforehand, that was not the case," said Matt Burns, executive director of ArOA. "So for our doctors, we're going to be implementing education resources from the association to help them with this transition, to make sure that these companies are following the law in conjunction with the Department of Insurance."

The regulations will take effect in August 2025, with additional provisions to roll out based on plan renewals or contract changes or by January 1, 2026.

Most recently, North Dakota secured comprehensive telemedicine provisions as part of its scope of practice legislation. 

"Our members' willingness to step up when called upon was truly incredible and we saw the passion our membership has for their profession," Kim Hacker, North Dakota Optometric Association's executive director, said in a release. "We built lasting relationships at the capitol and walked away with a positive reputation, and as many of you know, that's half the battle."

Jessica Heckman, OD

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