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NCX 470, Nicox’s lead clinical product candidate, is a novel NO-donating bimatoprost eye drop with a dual mechanism of action (nitric oxide and prostaglandin analog).

Nicox releases results from Whistler phase 3b trial in IOP lowering eye drops

Can a drop of perfluorohexyloctane, known to persist in the tear film, influence the precision of keratometry and ultimately affect surgical planning?

Evaluating the effects of perfluorohexyloctane on biometry: A Q&A with Kayla Karpuk, OD, from ARVO 2025

The recent study details the diagnostic value of a multimodal model utilizing both types of biomarkers when compared to unimodal models.

Researchers find Alzheimer disease detection potential in blood-based, retinal biomarkers

Because this year’s session is joint between the AOA and WCO, the session will feature work from members across both groups.

AOA announces top 5 posters in the 2025 live education session lineup

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Ophthalmology Times® spoke with Mitch Shultz, MD at ASCRS 2023 in San Diego where he shared insights from his presentation comparing patient results of the Hydrus stent and the iStent inject W with or without ABiC (or ab-interno canaloplasty).

ASCRS 2023: Comparing outcomes of 2 diﬀerent trabecular MIGS devices with or without ab interno canaloplasty for patients with glaucoma

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 2 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.

Pipeline

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

National Institutes of Health (NIH) researchers have developed a custom artificial intelligence (AI) system that digitally enhances images in order to better show tissues in the back of the eye to the point of being able to make out individual cells.

 By making these retinal pigment epithelium (RPE) cells visible, researchers have created implications for early detection of disease and the monitoring of treatment response, according to the news release.

The study, “Artificial intelligence assisted clinical fluorescence imaging achieves in vivo cellular resolution comparable to adaptive optics ophthalmoscopy,” was recently published in 

“AI potentially puts next-generation imaging in the hands of standard eye clinics. It’s like adding a high-resolution lens to a basic camera,” said Johnny Tam, PhD, investigator at NIH’s National Eye Institute and senior author of the study report, in the release.

The study included data gathered from 26 healthy eyes across patients, ranging from 22-63 years old.

 The AI utilization in the study was applied to images taken by ophthalmoscopes, with researchers first teaching the AI system to recognize image quality as poor, moderate, or good.

 The system was taught quality standards by being fed more than 1400 images from different parts of the retina taken by adaptive-optics ophthalmoscopy. Then, researchers fed the system corresponding images from the same retinal areas from standard ophthalmoscopy. After applying an image sharpness test, researchers found that AI-improved images were 8 times clearer than the original photos taken by ophthalmoscopy.

“Our system used what it learned from rating the images obtained from adaptive optics to digitally enhance images obtained with standard ophthalmoscopy,” said Tam in the release. “It’s important to point out that the system is not creating something from nothing. Features that we see in RPE cells with standard imaging are there, they’re just unclear.”

Researchers utilized the injection of indocyanine green (ICG) in order to increase contrast of anatomical features to aid in sharpening the images.

“Our ICG imaging strategy allows RPE cells to be quickly and routinely assessed in the clinic,” said Joanne Li, PhD, first author of the report and a biomedical engineer in Tam’s lab, in the release. “With AI, high quality images of the RPE cells can be obtained in a matter of seconds, using standard clinical imaging instruments.”

Another finding from the study was that although no differences in RPE cell parameters due to age were found and no RPE differences noted across ethnicities, RPE spacing was found to be larger with a smaller density in all eccentricities in female eyes when compared to male eyes. Spacing values in female eyes were on average 8% larger than in male eyes (

 test), with RPE density on average as 21% lower than in male eyes (

“Results show that both the RPE cell-to-cell spacing and density measurements based on [adaptive optics-indocyanine green, or] AO-ICG images are consistent with the values previously published by other imaging studies and histology, and the highest RPE density is observed in the fovea as previously described,” the study authors stated.

 “In addition, our results demonstrate an in vivo relationship between RPE packing and age that expands upon published literature. To our knowledge, we present the largest in vivo normative dataset for RPE cell structure in living human eyes, which will be particularly important for future studies using both AO and non-AO imaging to assess the RPE.”

NIH researchers supercharge ordinary clinical device to get a better look at the back of the eye. New release. National Institutes of Health. April 23, 2025. Accessed May 7, 2025. 

https://www.nih.gov/news-events/news-releases/nih-researchers-supercharge-ordinary-clinical-device-get-better-look-back-eye

Li J, Liu J, Das V, et al. Artificial intelligence assisted clinical fluorescence imaging achieves in vivo cellular resolution comparable to adaptive optics ophthalmoscopy. 

2025;5:105. https://doi.org/10.1038/s43856-025-00803-z

The system was taught quality standards by being fed more than 1400 images from different parts of the retina taken by adaptive-optics ophthalmoscopy. 

Researchers develop AI system that clarifies images of RPE, making cells visible

Bausch + Lomb has officially launched its Zenlens Chroma HOA scleral contact lenses in the United States. These lenses are designed to correct higher-order aberrations (HOA) using custom, wavefront-guided scleral lens technology that reduces symptoms such as hallows and glare to improve clarity and enhance vision.

“Zenlens Chroma HOA is a high-quality, customizable lens that fills a critical gap in scleral lens vision correction, especially for patients with complex corneal irregularities,” Yang Yang, president of global vision care at Bausch + Lomb, said in a press release. “Eye care professionals in the U.S. now have a new solution for patients that previously had limited options to improve vision quality.”

HOAs are complex irregularities in the lens or cornea that result from a variety of causes, such as irregular corneal shape, large pupils, scarring, previous eye surgeries, corneal dystrophy, keratoconus, and other medical conditions affecting the eye. As patients age, they may experience HOAs due to changes to the eye’s internal structures. Common symptoms include blurred vision, halos, glare, and difficulty seeing in low light conditions.

After the optometrist finds a secure scleral lens fit for the patient experiencing HOAs, Bausch + Lomb’s proprietary Zenlens technology, which includes SmartCurve and Bi-Elevation, applies custom HOA correction to the lens to reduce visual disturbance, blurring, and distortion.

“For years, I’ve had patients who struggle with visual distortions caused by higher-order aberrations, and there was little I could do beyond basic correction,” Jason Jedlicka, OD, chief of cornea and contact lens service and clinical professor at Indiana University School of Optometry, said in a press release. “With Zenlens Chroma HOA, I can offer a level of precision that wasn’t previously possible, and my patients can experience sharper vision and improved clarity, which has a significant impact on their quality of life.”

To support the US launch of Zenlens Chroma HOA, Bausch + Lomb is collaborating with Advance Medical and OVITZ for smoother implementation into practice workflows. OVITZ is providing its xwave aberrometer for precise HOA correction, and Advance Medical’s FocalPoints software platform supports seamless production of the Zenlens Chroma HOA design. The collaboration will ease custom lens production.

To learn more about Zenlens Chroma HOA, visit 

From the manufacturer: Important safety information for gas permeable and customized soft contact lenses

Problems with contact lenses and lens care products could result in serious injury to the eye. It is essential that patients follow their eyecare practitioner’s directions and all labeling instructions for proper use of lenses and lens care products, including the lens case. Eye problems, including corneal ulcers, can develop rapidly and lead to loss of vision.

Daily wear lenses are not indicated for overnight wear, and patients should be instructed not to wear lenses while sleeping. Clinical studies have shown that the risk of serious adverse reactions is increased when daily wear lenses are worn overnight.

Studies have shown that contact lens wearers who are smokers have a higher incidence of adverse reactions than nonsmokers.

If a patient experiences eye discomfort, excessive tearing, vision changes, or redness of the eye, the patient should be instructed to immediately remove lenses and promptly contact his or her eyecare practitioner.

Acute or subacute inflammation or infection of the anterior chamber of the eye.

Any eye disease, injury or abnormality, other than keratoconus, PMD, that affects the cornea, conjunctiva or eyelids

Severe insufficiency of lacrimal secretion (dry eye)

Corneal hypoesthesia (reduced sensitivity), if not aphakic

Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses

Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or using contact lens solutions

Allergy to any ingredient in a solution which is to be used to care for contact lenses

Any active corneal infection (bacterial, fungal or viral)

Eyes stinging, burning, itching, irritation or other eye pain

Comfort is less than when the lens was first placed on the eye

Feeling of something in the eye such as a foreign body, scratched area

Reduced sharpness of vision (poor visual acuity)

Blurred vision, rainbows, or halos around objects

Bausch + Lomb Launches Zenlens® CHROMA HOA™ in the United States. Bausch + Lomb. Press release. Published May 14, 2025. Accessed May 14, 2025. 

https://www.bausch.com/newsroom/news/?id=261

Bausch + Lomb’s propriety Zenlens technology, which includes SmartCurve and Bi-Elevation, apply custom HOA correction to the lens to reduce visual disturbance, blurring, and distortion.

Bausch + Lomb launches Zenlens Chroma HOA scleral lens in US

Prediction of Presbyopia Reading ADD and Its Progression: Using Digital Twin, Artificial Intelligence and Machine Learning-Based Algorithm

Predicting presbyopia reading ADD and progression with AI and machine learning algorithm Digital Twin

At the 2025 ASCRS meeting in Los Angeles, a concept was shared by AnnMarie Hipsley, DPT, PhD, for optometrists seeking to stay at the forefront of precision ocular care—the Digital Twin. More than a buzzword, a digital twin represents a virtual simulation of a real-world anatomical system, in this case, the human eye. Over the past decade, researchers have developed Virtual Eye Simulation Analyzer (VESA), a sophisticated AI- and physics-based model capable of simulating ocular anatomy and behavior with high fidelity.

VESA is not simply a generalized eye model. It can integrate refractive data, topography, biomechanical properties, and even simulate age-related changes in the eye—turning it into a predictive and diagnostic tool for clinicians managing complex conditions like presbyopia.

Presbyopia remains a progressive and pervasive challenge, typically addressed only at later stages—think 52-year-olds with +2.25D reading adds. But what if we could intervene earlier and manage presbyopia through its entire lifecycle?

That’s the vision behind VESA. By building 3D IDs of individual patients, the system models ocular aging from age 40 to 65 and beyond. Using platforms like Ansys and proprietary algorithms, researchers replicated not just the optical changes in accommodation, but also biomechanical shifts in the lens, zonules, sclera, and Bruch’s membrane.

The result? VESA can simulate and output customized treatment patterns tailored to age and ocular condition, paving the way for personalized presbyopia management from onset through advanced stages.

Looking ahead, VESA is set to revolutionize eye care by enabling virtual clinical trials and fail-fast innovation. This means intraocular lenses and other innovations can be trialed virtually—bypassing costly early-stage animal and human testing. Each patient becomes a rich data source, generating thousands of simulations that refine and improve treatment algorithms in real time.

Importantly, patient data is protected. Each digital twin is securely stored on a 3D ID “card,” enabling clinicians to access and update personalized treatment histories and predict future care needs. Think of it as a form of ocular Botox—patients will know when to return for treatment based on personalized aging simulations and digital guidance.

Ethical considerations and the road ahead

With such powerful technology comes ethical responsibility. VESA’s developers emphasized data privacy, algorithm transparency, and clinical validation. Human trials remain essential, but now, virtual models can run in parallel, drastically accelerating the pace and precision of innovation.

VESA and the digital twin approach mark a paradigm shift in how optometrists may soon diagnose, treat, and manage ocular conditions. The fusion of AI, biomechanics, and predictive modeling opens doors to individualized eye care that’s proactive, not just reactive—positioning the optometrist at the heart of next-generation visual health.

Digital Twin and VESA can integrate refractive data, topography, biomechanical properties, and even simulate age-related changes in the eye—turning it into a predictive and diagnostic tool for clinicians managing complex conditions like presbyopia.

Conference

Predicting presbyopia reading ADD and progression with AI and machine learning algorithm

Medical device company LumiThera has announced topline results from its LIGHTSITE IIIB extension trial assessing the Valeda Light Delivery System in patients with dry (non-neovascular) 

 Multiwavelength Valeda treatments were authorized by the US Food and Drug Administration (FDA) for dry AMD patients in order to improve vision in November 2024, according to a news release.

Valeda photobiomodulation (PBM) treatment is noninvasive and targets disease at the cellular level by delivering select wavelengths of light to enhance mitochondrial function to improve cellular energy production.

“There is now a non-invasive treatment for dry AMD patients that can improve vision and address the disease earlier, before permanent vision loss,” said Clark Tedford, PhD, president and CEO of LumiThera, in the release. “The extended trial results demonstrate that Valeda is potentially modifying the trajectory of vision loss in dry AMD patients and can offer sustainable benefits over several years with continued treatment.”

Valeda met the primary end point in the US LIGHTSIDE III trial, improving the best corrected visual acuity in patients for 24 months of >5 letters or equivalent to 1 line improvement on the eye chart.

 Additionally, Valeda was shown to be safe and effective, according to the release.

“The primary end point of the trial was BCVA gain. After another 13 months of treatment, although the size of the study population of LIGHTSITE IIIB is relatively small, >60% of the subjects that received Valeda treatment in both studies were still showing a benefit in vision of over one line,” said Quan Dong Nguyen, MD, MSc, FARVO, FASRS, professor of Ophthalmology, Medicine, and Pediatrics at the Stanford University School of Medicine, in the release. “What is exciting is this is the first and only FDA-authorized treatment that can improve vision with extended benefits out to 4.5 years, suggesting that earlier and extended treatment provides the best outcomes.”

“The LIGHTSITE IIIB extension trial results extend 2-year pivotal trial vision benefits out to 4.5 years and showed an excellent safety profile,” stated David Boyer, MD, FASRS, of Retina Vitreous Associates Medical Group in Beverly Hills, California, in the release. “This is very exciting data for early to intermediate dry AMD patients. The 4.5-year follow-up included a 20-month no-treatment period between the 2 trials, wherein the patients still maintained some vision benefit from the earlier pivotal trial and recovered vision upon retreatment in the extension trial.”

Valeda is intended to treat patients with a best correct visual acuity of 20/32 through 20/70 and who have dry AMD as characterized by The presence of at least 3 medium drusen {> 63 μm and ≤ 125 μm in diameter), or large drusen {> 125μm in diameter), or non-central geographic atrophy, in addition to the absence of neovascular maculopathy or center-involving geographic atrophy.

Valeda is shown to improve mean visual acuity of approximately 1 line of visual acuity (ETDRS) compared to those not receiving the treatment after approximately 2 years.

LumiThera’s LIGHTSITE IIIB extension trial topline results show extended vision improvement in dry AMD subjects. News release. LumiThera. May 8, 2025. Accessed May 12, 2025. 

https://lumithera.com/news/lumitheras-lightsite-iiib-extension-trial-topline-results-show-extended-vision-improvement-in-dry-amd-subjects/

Introducing the Valeda Light Delivery System. Valeda. Accessed May 12, 2025. 

Valeda met the primary end point in the US LIGHTSIDE III trial, improving the best corrected visual acuity in patients for 24 months of >5 letters or equivalent to 1 line improvement on the eye chart, according to the company.

LumiThera announces top-line results from LIGHTSITE IIIB extension trial assessing the Valeda Light Delivery System

The recent passage of West Virginia’s Senate Bill (SB) 565 has made the state the thirteenth in the country to authorize optometrists for ophthalmic lasers. The bill, which passed on May 1, allows for West Virginian ODs to provide certain in-office procedures such as laser treatments, according to an American Optometric Association (AOA) news release. The new law will take effect on July 9, 2025.

“We’re incredibly proud of what this means for our patients,” says Laura Suppa, OD, president of the West Virginia Association of Optometric Physicians (WVAOP), in the release. “This legislation will allow optometrists to deliver essential care, like managing certain eye conditions and performing minor procedures, without patients having to travel long distances or wait weeks for an appointment. It’s a win for public health and for West Virginia families.”

According to the AOA, more than 146,000 ophthalmic procedures have been performed safely by optometrists in the 12 other states that have permitted these scope of practice expansions.

“This is a monumental step forward for health care in West Virginia,” says Chad Robinson, WVAOP executive director, in the release. “SB 565 ensures that our highly trained optometrists can practice to the full extent of their education, training, and licensure—bringing more timely, accessible care to West Virginians where they are. We’re grateful to our representatives for recognizing the importance of this legislation.”

The AOA also stated in the release that advancing scope of optometric practice has led to an increase in the number of Medicare beneficiaries receiving YAG procedures, resulted in a gradual substitution between optometrists and ophthalmologists in the market for YAG procedures, and has made a larger impact in rural areas in comparison to urban areas.

“The future of optometry and access to critical patient eye health and vision care lies in the ability for doctors of optometry to adapt and expand the profession’s scope of practice, which has long been a key priority for the AOA and affiliates across the country,” says AOA President Steven T. Reed, OD, in the release. “The AOA is committed to supporting the fight for this important progress across the country.”

Other recent legislative optometric news in West Virginia is House Bill 3444, which has passed both the House and the Senate and is waiting to be signed into law. If signed, the bill would remove the mandate that all newborns in the state receive erythromycin ointment applied to their eyes after birth, which helps prevent ophthalmia neonatorum. The bill would repeal several sections of the Code of West Virginia that outline the duties and responsibilities related to the reporting, treatment, and management of ophthalmia neonatorum by health care providers, local health officers, and county officials.

“With removal of the mandate, legislators are opting for parental notification and choice as to whether their newborn child receives the ointment—a topical noninvasive intervention,” a statement from Prevent Blindness arguing against the bill stated.

 “The legislation does not, however, provide a clear method to define or ensure that informed parental consent has occurred. While providers will still move forward with clinical practice standards set by the American Academy of Pediatrics in application of a topical prophylaxis, the removal of a mandate creates a pathway for parental confusion and misinformation to the science that has driven this proven public health intervention.”

Major victory for West Virginia patients and optometrists. News release. American Optometric Association. May 8, 2025. Accessed May 12, 2025.

Joy J. Prevent Blindness urges West Virginia State Legislature to reject a bill proposing mandate removal for newborn eye care. 

https://www.optometrytimes.com/view/prevent-blindness-urges-west-virginia-state-legislature-to-reject-a-bill-proposing-mandate-removal-for-newborn-eye-care

The bill, which passed on May 1, allows for West Virginian ODs to provide certain in-office procedures.

Mitch Shultz, MD

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