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The novel intraocular lens works to restore dynamic range of vision following cataract surgery.

US FDA gives Atia Vision go-ahead to begin clinical study of the OmniVu Lens System

The OTC eye drops contain low-dose brimonidine tartrate 0.025%.

Bausch + Lomb launches LUMIFY Preservative Free redness reliever eye drops in US

The drop has the potential to become the first-ever ocular surface indication for an IG.

US FDA clears Grifols' Investigational New Drug application for immunoglobulin drops for the treatment of DED

The cross sector initiative that intends to drive a shift from reactive to proactive health care by leveraging ocular data through the means of oculomics.

Health care leader coalition launches Alliance for Healthcare from the Eye initiative

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BostonSight announced it has released FitConnect

3.0, a significant advancement in the web-based scleral lens fitting and order management system for BostonSight Scleral.

BostonSight was the first specialty lens manufacturer to provide eye care practitioners with a web-based platform for real-time scleral lens design, sent directly to the manufacturing lab. FitConnect is an innovative application that enables quadrant-specific, independent adjustments, SmartChannel technology, and SmartSight FSE for HOA correction without an aberrometer. FitConnect also integrates effortlessly with leading industry profilometers, empowering practitioners to digitally design custom scleral lenses using BostonSight’s advanced design feature, Smart360.

“When we introduced FitConnect in 2017, we delivered a platform that would empower practitioners to design BostonSight lenses the way they envisioned to address the needs of their patients and support their practice workflow. As BostonSight is both a busy clinic and a manufacturer, we have a unique perspective on not only patient care, but also clinical workflow and the needs of a business,” said Sara Yost, BostonSight President and CEO. “We are always looking for ways to improve the practitioner experience and their feedback has helped design FitConnect 3.0. The improvements provide a more intuitive user interface, as well as advancements in lens design capabilities. We are confident this upgrade will also improve overall fitting and practice efficiency. We’re excited to deliver the new FitConnect platform to our growing customer network around the world.”

In addition to the updated user interface, FitConnect 3.0 now allows practitioners to make changes to limbal clearance in addition to haptics in a quad-specific manner, design multifocal lenses with SmartFocus, and add SmartChannels specifically for reducing lens suction or vaulting anatomical obstacles. FitConnect 3.0 provides advanced practice management tools and guides practitioners with lens design by providing recommended measurements and fitting tips throughout the order process. The platform also supports multiple languages and incorporates feature flex, allowing the platform to be customized for BostonSight’s global manufacturing partners.

Coming later in 2025, FitConnect will add Quad-Elevation, an industry-leap forward in the custom design of scleral lenses. Quad-Elevation will let practitioners modify the mid-peripheral corneal zone. With quad-specific customization in the haptic, limbal and mid-peripheral corneal zones, practitioners will be able modify the lens across 12 independent zones. This level of available customization ensures that practitioners can easily fit patients with irregular corneas and scleral shapes, providing best comfort, visual acuity, and long-term ocular health.

BostonSight is a nonprofit health care organization that advances the treatment of corneal irregularities and ocular surface disease through specialty lenses. BostonSight’s ongoing commitment to research and achieving optimal patient outcomes through innovative scleral lens design, education, and technology has saved the sight of thousands of people around the world.

Enhanced scleral lens design and order management platform for practitioners provides exceptional user experience.

BostonSight Announces FitConnect 3.0  

Nicox has announced the results of its Whistler phase 3b exploratory clinical trial investigating the intraocular pressure (IOP)-lowering effects of NCX 470 ophthalmic solution, 0.1%, in healthy volunteers and ocular hypertensive patients.

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

The Whistler Phase 3b exploratory trial was a double-masked, placebo-controlled study in 18 healthy volunteers or patients with ocular hypertension. Measurements were taken at baseline and after 8 days at 1 PM and, for some parameters, at 3 PM. Patient population in the trial was primarily normotensive healthy volunteers with mean baseline IOPs of 16.6 mm Hg and 16.9 mm Hg for NCX 470 and placebo-treated patients, respectively.

Results showed that changes in aqueous humor flow rate trended toward significance when compared to placebo (

=.072). Furthermore, outflow facility was positive at 1 PM (

=.004). The company noted in the results it believes this change is due to “the effect of nitric oxide on the trabecular meshwork.”

IOP lowering and uveoscleral outflow were statistically significant at all timepoints measured, according to the company, while episcleral venous pressure did not show a notable trend.

Doug Hubatsch, chief scientific officer of Nicox, commented on the results in a press release from the company.

“These positive exploratory results suggest that further investigation may be warranted into the dual mechanism effect of NCX 470 on intraocular pressure,” said Hubatsch. “The therapeutic characteristics of NCX 470 demonstrated in the phase 3 program so far show that we have an approvable and differentiated asset with a promising clinical profile.

The Whistler trial was an exploratory trial and is not a requirement for the submission of new drug applications for NCX 470, according to the company, and thus will not impact the development timeline.

A second phase 3 clinical trial, named Denali, is currently ongoing, and results are expected from that in Q3 of 2025. The last American patient in Denali has completed their final visit, with Chinese patients having already completed theirs.

The company also noted it plans to submit a new drug application to the US Food and Drug Administration for NCX 470 and plans on using Mont Blanc and Denali to fulfill the regulatory requirements for safety and efficacy. The company did not specify a timeline for the NDA submission.

Nicox announces results of the exploratory Whistler phase 3b glaucoma trial. Published May 14, 2025. Accessed May 15, 2025. 

https://www.nicox.com/wp-content/uploads/EN_WhistlerResultsMay2025_PR_FINAL.pdf

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 analogue).

Pipeline

Canonical

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

An investigation into the association between COVID-19 and childhood astigmatism showed substantial increases in the prevalence and severity of refractive and corneal astigmatism, independent of myopia,

 reported Ka Wai Kam, MSc, the first study author from the Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, and the Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong Special Administrative Region, China.

Kam and colleagues explained, “Considering the association between myopia and astigmatism, 2 local studies evaluated the prevalence of refractive astigmatism in Hong Kong during the enforcement of COVID-19 restrictions in 2020 and compared with historical data from earlier years.

 The high co-occurrence of astigmatism with myopia suggested that the change in the prevalence of refractive astigmatism might result from axial elongation. Nonetheless, no data exist on the changes in the corneal component of astigmatism, which might also be related to an increase in refractive astigmatism, and no study has reported the prevalence of astigmatism after the lift of social and school restrictions.”

They conducted a population-based cross-sectional study that stratified all the primary schools registered with Education Bureau in Hong Kong into 7 clustered regions used by Hospital Authority Services in Hong Kong.

The students, aged 6 to 8 years, underwent comprehensive ocular examinations at 2 academic medical centers in Hong Kong from 2015 to 2023. Astigmatism was measured with optical biometry and auto-refractor after cycloplegia. The primary outcomes were the annual prevalence rates of refractive astigmatism and corneal astigmatism.

A total of 21,655 children were included in the study (52.9% boys; mean age, 7.31 years).

The authors found a prevalence rate of refractive astigmatism of at least 1.0 diopter (D) in 21.4% and corneal astigmatism of at least 1.0 D 59.8% in 2015 that increased to 34.7% (difference, 13.3%; 95% confidence interval [CI], 9.3%-17.3%) and 64.7% (difference, 4.9%; 95% CI, 0.5%-9.2%), respectively, in 2022 to 2023.

The COVID-19 pandemic was associated with a 20% increase in the risk of refractive astigmatism (odds ratio [OR], 1.20; 95% CI, 1.09-1.33), a 26% increase in the risk of corneal astigmatism (OR, 1.26; 95% CI, 1.15-1.38), a 0.04-D magnitude of refractive astigmatism (95% CI, 0.02-0.07), and a 0.05-D magnitude of corneal astigmatism (95% CI, 0.02-0.08) (

 < 0.001 for all comparisons) compared with the prepandemic period of 2015 to 2019 and after adjusting for sociodemographic factors, parental astigmatism, and child myopia, the investigators reported.

They concluded, “This study found an increase in both the prevalence and severity of refractive astigmatism and corneal astigmatism after the COVID-19 pandemic in schoolchildren in Hong Kong. Corneal changes especially along the steepest meridian may explain some of the progression of the corneal astigmatism. The potential impact of higher degrees of astigmatism may warrant dedicated efforts to elucidate the relationship between environmental and/or lifestyle factors, as well as the pathophysiology of astigmatism, in order to preserve children’s eyesight and quality of life.

Kam KA, Shing E, Zhang Y, et al. Prevalence and severity of astigmatism in children after COVID-19. 

2025;143:383-391. doi:10.1001/jamaophthalmol.2025.0205

Wong SC, Kee CS, Leung TW. High prevalence of astigmatism in children after school suspension during the COVID-19 pandemic is associated with axial elongation. 

Liang Y, Leung TW, Lian JT, Kee CS. Significant increase in astigmatism in children after study at home during the COVID-19 lockdown. 

Significant association between COVID-19 and astigmatism in Hong Kong schoolchildren

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.

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.

Andrew D. Pucker, OD, PhD, FAAO, FSLS

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