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Susana Marcos, PhD, discusses the implications her research presents for the role optical coherence tomography (OCT) could play in presbyopia and myopia accommodation efforts.

ARVO 2025: Lens thickness as a significant biomarker for accommodation in presbyopia

Articles

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

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Private practice eye care providers’ ability to immediately administer antibiotic eye drops or have them overnighted to the patient is a giant step forward for practice and patient.

Fortified antibiotic advance improves corneal infection treatment paradigm

Brian Shafer, MD, discussed Fortisite and the ability to treat corneal ulcers at the 2023 ASCRS annual meeting in San Diego.

ASCRS 2023: Fortisite for corneal ulcers

At ARVO 2025, Mark Bullimore, MCOptom, PhD, emphasized the need for more accurate, condition-specific tools in evaluating myopic eye growth and treatment efficacy.

ARVO 2025: Rethinking centile growth curves in myopia management with Mark Bullimore, MCOptom, PhD

At the 2025 ARVO conference in Salt Lake City, Mark Bullimore, MCOptom, PhD, of the University of Houston College of Optometry shared a compelling critique of the current use of centile growth curves for axial length in myopia management. Speaking directly to optometrists, Bullimore emphasized the need for more accurate, condition-specific tools in evaluating myopic eye growth and treatment efficacy.

The problem with conventional growth curves

Centile growth curves—long used in pediatrics to track height and weight—are increasingly being applied to axial length measurements in children. According to Bullimore, this is where the utility of these curves begins and ends in the context of myopia.

"These curves are based on data from all children, not just myopic ones," he explained. "So they substantially underestimate axial elongation in myopic children."

This limitation has 2 major consequences:

 The curves fail to reflect how fast a myopic child's eye is likely to elongate.

 They hinder clinicians from accurately determining whether myopia control treatments are working.

Bullimore also cautioned against relying on axial length alone to predict myopia onset. While it has some predictive value, "cycloplegic refractive error is far more accurate," he said.

To manage myopia effectively, Bullimore recommends using data derived solely from myopic children. This would allow practitioners to assess the expected axial elongation in untreated cases and compare it meaningfully against treated ones.

“What you want is to know how quickly the average untreated myopic child’s eye will grow,” he said. “And ideally, you’d have confidence intervals or centile ranges 

By separating myopic from nonmyopic data, clinicians can gain a more realistic benchmark and better evaluate the success of interventions like orthokeratology or low-dose atropine.

Bullimore’s insights at ARVO underscore the importance of precision in pediatric myopia care. As the prevalence of childhood myopia continues to rise, refining the tools we use to monitor progression and assess treatment outcomes is more critical than ever.

Conference

Biopharmaceutical company Perfuse Therapeutics has announced positive 24-week results from its phase 1/2a trial of PER-001, a first-in-class endothelin antagonist intravitreal implant for glaucoma.

 Data from the completed trial were presented at the Association for Research in Vision and Ophthalmology (ARVO) meeting earlier this week, according to a news release.

“Our mission is to develop the first disease-modifying treatment for glaucoma, the leading cause of irreversible global blindness with no approved therapies,” said Sevgi Gurkan, MD, CEO and founder of Perfuse Therapeutics, in the release. “These data are very promising, with PER-001 improving vision in glaucoma patients. We plan to advance the clinical development of PER-001, with initiation of an adaptive phase 2b trial in glaucoma in the second half of 2025 that we believe could serve as one of 2 pivotal studies required for registration.”

The phase 1/2a clinical trial was a multicenter, 2-part trial that assessed the safety and tolerability of the PER-001 intravitreal implant in patients with glaucoma. Other exploratory objectives of the study included pharmacodynamic (optic nerve head blood flow), functional (visual field), and structural (optical coherence tomography [OCT] retinal nerve fiber layer [RNFL]) effects of PER-001.

The phase 1 portion of the trial was a first-in-human, open-label, single ascending dose (SAD) study that assessed the safety and tolerability of 2 doses in a single PER-001 administration in 6 patients with advanced glaucoma (n=3 per dose). Phase 2a was a randomized, patient and reading center masked study that evaluated PER-001 low and high doses against sham control in patients with progressive mild-to-moderate glaucoma (n=approximately 8 for each of the low dose, high dose, and sham control groups). Both portions of the study included 33 participants who were followed for 24 weeks after dosing.

Data from the trial demonstrated that when added to existing standard of care intraocular pressure (IOP) reducing therapies, the single intravitreal administration of PER-001 aided in increasing ocular blood flow and improved both visual function and anatomic structure with registrable outcomes measured by visual field sensitivity and OCT RNFL thickness. Specifically, improvement in visual field mean deviation from baseline was +1.5 and +1.1 decibel (dB) per year at 24 weeks for high dose and low dose, respectively. The increase in RNFL thickness from baseline was +7.7 and +2.4 microns per year for low and high dose, respectively, as measured by OCT at 24 weeks in phase 2a. The study also demonstrated a strong and linear relationship between functional and structural improvements (Pearson Correlation Coefficient = 0.721; 

The trial also demonstrated that PER-001 was safe and well-tolerated over the 6-month period. The 2 drug-related adverse events noted were both mild, intermittent, and self-resolved vitreous floaters. No instances of endophthalmitis, intraocular inflammation, uveitis, or retinal vasculitis were reported.

“For decades, glaucoma treatments have focused on lowering intraocular pressure (IOP). Yet, many patients still experience vision loss and progress to blindness,” said Steven Mansberger, chief of ophthalmology and director of glaucoma services at Legacy Devers Eye Institute, investigator of the study, and presenter of the ARVO presentation, in the release. “What is particularly remarkable is that treatment with PER-001 led to improvements in ocular blood flow, optic nerve structure, and visual function. These findings suggest a potentially transformative approach for the treatment of glaucoma by targeting the endothelin pathway, a well-established mediator of vascular dysfunction in the disease. Notably, this represents the first time endothelin antagonism has been studied in the human eye, marking the potential start of an exciting new era of treatment for patients with glaucoma.”

Perfuse Therapeutics announces positive results from the completed phase 1/2a clinical trial of PER-001 intravitreal implant in patients with glaucoma. News release. Perfuse Therapeutics. May 6, 2025. Accessed May 8, 2025. 

https://perfusetherapeutics.com/perfuse-therapeutics-announces-positive-results-from-the-completed-phase-1-2a-clinical-trial-of-per-001-intravitreal-implant-in-patients-with-glaucoma/

The first-in-class endothelin antagonist intravitreal implant aided in increasing ocular blood flow and improved both visual function and anatomic structure, according to the company.

ARVO 2025: Perfuse Therapeutics announces positive results from phase 1/2a trial of PER-001, an intravitreal implant for glaucoma

Prevent Blindness has vocalized its full support of the recent reintroduction of the Early Detection of Vision Impairments for Children Act (EDVI), or HR 2527, in the US House of Representatives.

 The bipartisan legislation would work to establish grants for states and communities to apply for and access for the implementation of new approaches and improved public education regarding children’s vision, early detection of vision concerns, referrals for eye examinations, and follow-up mechanisms, among other initiatives, according to the release.

“Far too many children in the United States face unnecessary barriers to essential vision care,” said Jeff Todd, president and CEO of Prevent Blindness, in the release. “The EDVI Act brings us closer to a future where every child has access to the vision screenings, eye exams, and treatment they need to see clearly and thrive. We are proud to support this critical legislation that prioritizes children's eye health and educational success.”

The EDVI Act was first introduced in the House in May 2024 and was reintroduced on March 31, 2025. The bill has maintained the same cosponsors in the Congressional Vision Caucus cochairs, Rep Gus Bilirakis (FL-12), and Rep Marc Veasey (TX-33). Companion legislation to the bill is expected to be introduced in the US Senate in the near future.

 Dozens of public health organizations have also voiced their support for the EVDI Act, including the American Optometric Association, the American Academy of Optometry and Ophthalmology, Lighthouse Guild, The Vision Council, World Council of Optometry, and many others.

If passed, the EDVI Act would allow the US Department of Health and Human Services’ Health Resources and Services Administration to award grants and cooperative agreements to eligible states and communities.

 The act would also work to “establish a coordinated public health system for vision health and eye care diagnosis and treatment, develop state-based data collection and performance improvement systems, and promote wrap-around services for children who experience vision loss,” according to the release.

“As an American who has suffered from poor vision since childhood, I have a firsthand understanding of how critical early detection and treatment is when it comes to ensuring that all children have the best possible start in life,” said Bilirakis in the release. “The EDVI Act, reintroduced this year, will ensure all children get the screening and care they need at the right age by creating the first-ever federally funded program to address children’s vision and eye health. This legislation will empower states and communities, like mine, to improve systems of care for our youngest citizens and their families.”

The EVDI Act would also provide resources through the Centers of Disease Control and Prevention for technical assistance and guidance for new children’s vision systems of care, in addition to aiding the conducting of research. Current resources to provide information to help legislators and advocates further the act include Prevent Blindness’ 

, which breaks up children’s vision issues and needs, state-level regulations, and prevalence of vision impairment and blindness by geographic location. The organization also has a state-specific 

 with brief overviews of early intervention efforts by state based on data from the 2022 National Survey of Children’s Health that is free to download.

“When I was in elementary school, I struggled to see the board, and it made learning incredibly difficult. It wasn’t until I had a vision screening and got the right pair of glasses that everything changed for me,” said Veasey in the release. “I know from personal experience that vision issues can hold a child back, and how something as simple as a pair of glasses can unlock their potential. No child should fall behind simply because they can’t see. With the reintroduction of The Early Detection of Vision Impairments for Children Act, we can all work together to ensure all children, in Texas and across the country, have access to the screenings they need to see clearly and reach their full potential.”

For those interested in the advocacy process, Prevent Blindness and the National Center for Children’s Vision and Eye Health at Prevent Blindness will be hosting a free 

Prevent Blindness applauds reintroduction of Early Detection of Vision Impairments for Children Act. News release. Prevent Blindness. May 6, 2025. Accessed May 6, 2025.

Early Detection of Vision Impairments for Children (EDVI) Act. Prevent Blindness. Accessed May 6, 2025. 

https://advocacy.preventblindness.org/edvi-act-of-2024/

The Early Detection of Vision Impairments for Children Act (EDVI), or HR 2527, would allow the federal government to award grants and cooperative agreements to eligible states and communities for children's vision care initiatives. 

Prevent Blindness voices support for reintroduction of EDVI Act

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. 

Brian Shafer, MD

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