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CLI Visionaries provide professional perspectives on best practices and highlight the EASY (Eyes, Awareness, Safety & You) Way program in the series.

CLI publishes video series to educate new soft contact lens wearers

Deborah Ristvedt, DO, and Melissa Tawa, OD, FAAO, detail the benefits of interventional glaucoma during their CRU 2025 presentation.

CRU 2025: Rethinking first-line glaucoma therapy

The Vision Council report highlights providers’ expectations and the perceived impact of economic factors including tariffs, inflation, staffing and hiring, and technological integration including telehealth and artificial intelligence.

Optimism persists among eye care providers despite looming tariffs

Under the Vevye Access for All program, patients with a Klarity-C prescription can switch to Vevye for $59 per bottle.

Harrow expands Vevye Access for All program to encourage switch from Klarity-C

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Myopia- Management

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Authors

How to fit lenses with simple devices and when to expand your armature.

Basic and beyond: technology for every level of scleral lens management

HOYA has announced the launch of its VisuPro All Day and VisuPro Flex advanced focus spectacle lenses to help patients that are beginning to experience age-related presbyopia.

 The new lenses are designed for young presbyopes, ranging in age from their late 30s to mid-40s, who may be either existing spectacle wearers or non-wearers, according to a news release.

“Uncorrected refractive error is the leading cause of vision impairment globally, yet current market offerings fail to address the unique needs of young presbyopes,” said John Goltermann Lassen, CEO at HOYA Vision Care, in the release. “Innovations to manage first presbyopic symptoms at the earliest stage are essential to minimize the impact of presbyopia on patients’ quality of life and ensure continued clarity of vision.” 

The lenses use HOYA’s Binocular Harmonization Technology (BHT) that considers the prescription for both eyes to calculate the prescription in the lenses for focusing, stability, and enhanced depth of vision. The Focus Max Optimization allows for additional vision support at close distance. The lenses can help reduce eye strain or visual fatigue when working with digital devices, which caters to the interest of younger patients with presbyopia, according to results from a HOYA survey. This research found that 53% of existing spectacle wearers and 60% of non-spectacle wearers between 36 and 44 years of age have increasing problems seeing clearly in the near distance and when using digital devices.

"VisuPro lenses represent a major advancement in our approach to pre-presbyopia," said Griffith Altmann, chief technology officer at HOYA Vision Care, in an exclusive quote for 

. "By focusing on patients in the early stages of the condition, we’re offering a proactive solution that helps busy people beginning to experience symptoms continue to enjoy their lives to the full without compromising on visual comfort or performance. At HOYA, we’re committed to developing technologies that meet the evolving needs of patients, ensuring they can continue to enjoy clear and seamless vision at every age.”

HOYA launches VisuPro advanced focus spectacle lenses for patients experiencing first symptoms of presbyopia. News release. HOYA. April 2, 2025. Accessed April 3, 2025.

The new lenses are designed for young presbyopes, ranging in age from their late 30s to mid-40s, who may be either existing spectacle wearers or non-wearers.

HOYA launches new advanced focus spectacle lenses for younger patients with presbyopia

Clinical stage biotechnology company Tenpoint Therapeutics has announced its New Drug Application (NDA) submission to the US Food and Drug Administration (FDA) for brimochol PF for the treatment of presbyopia.

 Brimochol PF has the potential for a best-in-class product profile due to its unique combination of brimonidine and carbachol in a pupil-modulating eye drop, according to a news release.

“The submission of the US NDA for brimochol PF marks a significant milestone for our company,” said Henric Bjarke, Tenpoint Therapeutics CEO, in the release. “As we accelerate the build-out of our commercial team in preparation for the anticipated launch in the first half of 2026, we are incredibly proud of the dedication and tireless work that has brought the company to this point. We look forward to collaborating closely with the FDA throughout the NDA review process.”

Brimochol PF’s combination of brimonidine and carbachol produces a “pinhole effect,” which is intended to improve depth of focus and sharpen near and distant impact, benefiting the patient with greater peak efficacy and duration relative to monotherapy alone, according to the release. If approved by the FDA, this formulation would be the first combination therapy for presbyopia.

Tenpoint’s NDA submission is supported by positive data from the first pivotal phase 3 BRIO-I trial, which demonstrated the benefit of the combination therapy over individual component. The company noted that this is a requirement for FDA approval of a fixed dose combination. Additionally, brimochol PF achieved all primary and secondary near vision improvement endpoints in a second vehicle-controlled phase 3 BRIO-II trial. Results were statistically significant with 3-lines or greater improvement in binocular uncorrected near visual acuity over 8 hours without the loss of 1 line or more in binocular uncorrected distance visual acuity. The therapy was well tolerated with no serious treatment-related adverse events over a total of 70,000 treatment days in the BRIO-II trial.

“The NDA submission includes data from the world’s largest and longest (12 months) efficacy and safety study in presbyopia, with more than 70,000 dosing days of data. Brimochol PF demonstrated a very favorable tolerability profile and no reduction in efficacy over the 12-month study duration,” said Rhett Schiffman MD, MS, MHSA, chief medical officer and head of Research and Development at Tenpoint, in the release. “We also observed additional patient benefits beyond near vision improvements such as statistically significant increases in reading speed and significant lower rates of hyperemia (eye redness) compared with carbachol (p=0.001) and importantly, the rate of vitreous detachment was similar to vehicle. The increase in peak effect and duration of brimochol PF over carbachol alone

, along with the decreased incidence of hyperemia

 and the lower rate of vitreous detachment

 are all consistent with previously reported mechanisms of action of brimonidine or related compounds.”

The FDA will conduct a standard 60-day filing review to assess the application for formal review.

Tenpoint Therapeutics Ltd. submits New Drug Application to US FDA for BRIMOCHOL PF for the treatment of presbyopia. News release. Businesswire. April 8, 2025. Accessed April 8, 2025. 

https://www.businesswire.com/news/home/20250408026931/en/Tenpoint-Therapeutics-Ltd.-Submits-New-Drug-Application-to-U.S.-FDA-for-BRIMOCHOL-PF-for-the-Treatment-of-Presbyopia

Verhoeven RS, Burke, J, Schiffman, R. Nonclinical Pharmacokinetics and Pharmacodynamics of Brimochol, a Combination Product for the Treatment of Presbyopia. 

https://iovs.arvojournals.org/article.aspx?articleid=2780074

Ackerman SL, Torkildsen GL, Mclaurin E, & Vittitow JL. Low‐dose brimonidine for relief of ocular redness: integrated analysis of four clinical trials. 

Kubo C, Suzuki R. Involvement of prejunctional alpha 2-adrenoceptor in bovine ciliary muscle movement. 

Brimochol PF’s combination of brimonidine and carbachol produces a “pinhole effect,” which is intended to improve depth of focus and sharpen near and distant impact.

Tenpoint Therapeutics submits NDA application to US FDA for brimochol PF for the treatment of presbyopia

Opus Genetics announced the 1-month open-label phase 1/2 results from the first pediatric patients treated with its investigational gene therapy candidate, OPGx-LCA5, for Leber congenital amaurosis (LCA) 5-related inherited 

 (IRD). IRD is a rare and severe genetic condition that causes early-onset vision loss.

The new data build upon previously reported 6- and 12-month positive results from adult patients treated in the same study.

These results matter, the company said, because:

LCA5-related IRD has no approved treatments.

Gene therapy offers the potential to restore vision early, before irreversible retinal damage occurs.

This is part of a growing effort to bring gene therapy into pediatric care, where early intervention may have a profound impact on healthspan and quality of life.

The company described that their early data are “meaningful: the 16-year-old participant showed clinically significant improvement in visual function after just 1 month, reporting brighter vision and new independence in mobility and reading, without any drug-related adverse events.”

The patient received 1 subretinal injection of OPGx-LCA5 and clinically meaningful improvement in vision was observed at the 1-month time point. No drug-related adverse events were reported.

A second pediatric patient was recently dosed, and the pediatric cohort is expected to complete enrollment in the second quarter of 2025, according to the press release. The initial data from all 3 patients is anticipated in the third quarter of 2025.

These results build on 6- and 12-month data in adults, where sustained improvements in visual function have been observed. A potential registrational trial could begin as early as the first quarter of 2026, following a productive Type D meeting with the US Food and Drug Administration.

“The preliminary results observed in our pediatric patient are encouraging and are consistent with the improvements we previously observed in adults," Tomas Aleman, MD, Scheie Eye Institute Perelman, the study principal investigator, said.

"[The patient] noticed that objects were significantly brighter and was able to distinguish letters and navigate with an independence she had never had before, after only 1 month following treatment. We’re excited to continue enrolling patients and studying improvement over longer periods of time in this important study.”

George Magrath, MD, chief executive officer of Opus Genetics, added, “We believe these findings provided further evidence supporting the potential of OPGx-LCA5 to restore meaningful vision in patients affected by LCA5. The meeting with the FDA regarding the design of our program may lead to the start of a trial in 2026. Early intervention may be particularly beneficial in pediatric patients, given the progressive nature of this disease.”

The 1-year results are going to be presented at the annual meeting of the Association for Research in Vision and Ophthalmology on May 4, 2025.

An FDA Type D meeting discussed the potential regulatory path for OPGx LCA5, including the design of a potential registrational study. Opus proposed a single arm, adaptive pivotal study, to enroll as few as 19 patients, with a primary end point utilizing the multiluminance orientation and mobility test (MLoMT), which is a functional vision and patient mobility test. MLoMT is a virtual-reality version of the multiluminance mobility test, which provided evidence to support a prior FDA approval.

The company also received constructive feedback on its proposed statistical analysis plan as well as chemistry, manufacturing, and controls (CMC). The FDA requested additional information on these topics, and Opus plans to submit further materials and continue discussions with the FDA.

Opus anticipates the pivotal trial could initiate in Q1 2026, according to the press release.

1. Opus Genetics, Inc. Opus Genetics, Inc. Published April 8, 2025. Accessed April 8, 2025. 

https://ir.opusgtx.com/press-releases/detail/483/opus-genetics-announces-one-month-clinical-data-from-pediatric-patient-in-phase-12-trial-of-opgx-lca5-gene-therapy-in-inherited-retinal-diseases

Good safety profile and “meaningful improvement” in vision in patient with Leber congenital amaurosis.

Pipeline

Canonical

Opus Genetics issues 1-month pediatric gene therapy results

Dr. Rachelle Lin highlights the urgent need for early intervention in childhood myopia, discusses associated retinal and systemic risks, and emphasizes the long-term impact of axial length control in reducing serious ocular complications.

CRU 2025: Managing myopia today to prevent vision loss tomorrow

At the CRU Eye Symposium, Rachelle Lin, OD, FAAO, associate professor at the Southern California College of Optometry at Marshall B. Ketchum University, joined Andrew S. Morgenstern, OD, FAAO, FNAP, to deliver a comprehensive overview of both clinical guidelines and long-term ocular risks associated with 

. The CRU Eye Symposium took place March 28 to 30, 2025, in Napa Valley, California.

Morgenstern opened the session by highlighting the updated American Optometric Association (AOA) guidelines on myopia, which he codeveloped with a team of experts. These guidelines, now available on the AOA website, provide structured recommendations to help clinicians implement effective myopia management strategies in practice.

Lin’s portion of the talk focused on the retinal and systemic implications of myopia. She emphasized that even low levels of myopia can significantly elevate the risk of sight-threatening conditions such as myopic macular degeneration, retinal detachment, posterior subcapsular (PSC) cataracts, and open-angle glaucoma. These risks escalate with increasing myopic severity, underscoring the critical importance of early intervention and axial length control.

A key topic in Lin’s presentation was identifying and managing pediatric patients who are trending toward high myopia. She referenced recent studies indicating that children under age 10 who are projected to reach -6.00 D or higher—whether spherical or cylindrical—should be considered high-risk. These patients may face not only ocular complications but also potential systemic associations, including inherited retinal dystrophies, connective tissue disorders, and complications from prematurity, such as retinopathy of prematurity. Such complex profiles require optometrists to maintain a high index of suspicion and consider multidisciplinary referrals when appropriate.

Lin concluded by acknowledging the vital work of optometrists who are deeply engaged in myopia management. While preventing future pathology often goes unrecognized by patients, she emphasized that the long-term impact is profound. As a low-vision practitioner, she frequently sees the devastating outcomes of unmanaged myopia and affirmed that effective myopia control, especially in managing axial elongation, plays a crucial role in preserving vision and quality of life.

Dr Rachelle Lin highlights the urgent need for early intervention in childhood myopia, discusses associated retinal and systemic risks, and emphasizes the long-term impact of axial length control in reducing serious ocular complications.

Conference

The US Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg) for the treatment of 

wet age-related macular degeneration (AMD)

The company previously resubmitted the BLA in February 2025.

The company noted in a press release that the FDA determined the resubmission of the BLA was a Class 2 review, which results in a 6-month review period from the date of resubmission. A Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025, was set by the FDA. If approved, the drug will be branded as Lytenava in the US.

Lawrence Kenyon, chief financial officer and interim CEO of Outlook Therapeutics, commented on the resubmission in a press release from the company.

“Our team has worked diligently to advance our development and regulatory strategies for ONS-5010 to get to this point, and we are proud of the continued progress we have been able to achieve,” said Kenyon. “This BLA acceptance and PDUFA date are significant milestones in our continued mission to offer clinicians and their patients the first and only on-label, ophthalmic bevacizumab to treat wet AMD. We are committed to bringing an ophthalmic bevacizumab to market in the United States and are continuing our activities for potential commercialization.”

In August of 2023, the FDA issued a complete response letter (CRL)

 to Outlook for the company’s BLA of ONS-5010. According to the company, the FDA determined it could not approve the BLA during this review cycle due to several CMC issues, open observations from preapproval manufacturing inspections, and a lack of substantial evidence.

The BLA resubmission is based on the efficacy and safety demonstrated in NORSE EIGHT, as well as additional chemistry, manufacturing, and controls (CMC) information requested by the FDA. 

 the organization informed Outlook it could conduct a noninferiority study evaluating ONS-5010 vs ranibizumab in a 12-week study of treatment-naive patients with a primary efficacy end point at 8 weeks (Norse Eight).

Outlook Therapeutics announced results from the completed analysis of the 12-week safety and efficacy results for Norse Eight

 which indicated that ONS-5010 demonstrated clinically meaningful anatomic and functional improvements at each study time point.

The company stated that the data provided “provides the required evidence to support approval of the ONS-5010 BLA in the United States.”

Bevacizumab-vikg is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells.

Outlook Therapeutics announces acceptance of biologics license application by U.S. FDA for ONS-5010 as a treatment for wet AMD. Published April 4, 2025. Accessed April 7, 2025. 

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-acceptance-biologics-license-0

Harp M. Outlook Therapeutics resubmits BLA for ONS-5010 for treatment of wet AMD. Published February 28, 2025. Accessed April 9, 2025. 

https://www.ophthalmologytimes.com/view/outlook-therapeutics-resubmits-bla-for-ons-5010-for-treatment-of-wet-amd

Hutton D. FDA issues CRL for Outlook Therapeutics’ ONS-5010. Published August 30, 2023. Accessed April 9, 2025. 

https://www.optometrytimes.com/view/fda-issues-crl-for-outlook-therapeutics-ons-5010 

Hutton D. Outlook Therapeutics requests Type A meeting with FDA. Published September 29, 2023. Accessed April 9, 2025. 

https://www.ophthalmologytimes.com/view/outlook-therapeutics-requests-type-a-meeting-with-fda

Harp M. Outlook Therapeutics completes analysis of 12-week safety and efficacy results of NORSE EIGHT. Published January 16, 2025. Accessed April 9, 2025. 

https://www.ophthalmologytimes.com/view/outlook-therapeutics-completes-analysis-of-12-week-safety-and-efficacy-results-of-norse-eight

A Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025, was set by the organization.

FDA accepts updated biologics license application from Outlook Therapeutics for ONS-5010 for the treatment of wet AMD

Clinical stage biotech company Tenpoint Therapeutics announced positive topline results from BRIO-II, a Phase 3 pivotal trial assessing BRIMOCHOL PF for the treatment of presbyopia. According to a company news release, the clinical trial successfully met pre-specified visual acuity primary endpoints in both the US and European Union (EU)/United Kingdom (UK) with statistically significant near vision improvements recorded at all time points over 8 hours (p<0.008). Those primary endpoints were agreed upon with the US FDA, European Medicines Agency, and the UK Medicines and Healthcare Products Regulatory Agency.

The 3-arm, multicenter, randomized, double masked, safety and efficacy study (NCT05135286) evaluated BRIMOCHOL PF, a carbachol/brimonidine tartrate fixed-dose combination topical ophthalmic solution, in comparison to a carbachol monotherapy topical ophthalmic solution and a vehicle topical ophthalmic solution in the 629 participants with emmetropic phakic or pseudophakic presbyopia. Participants were enrolled in 47 different sites in the US.

“Tenpoint Therapeutics is the only company in the presbyopia category to demonstrate contribution of elements with BRIMOCHOL PF, paving the way for a combination drug approval that offers the additional benefits of brimonidine,” said Rhett Schiffman, MD, MS, MHSA, chief medical officer and head of Research and Development at Tenpoint, in the release. “In our studies, brimonidine increased the magnitude and duration of action of carbachol and reduced the incidence of hyperemia (eye redness) over carbachol alone. BRIMOCHOL PF is the only presbyopia correcting eye drop to have gone through a 12 month safety study. It was very well tolerated over 12 months of continuous dosing and subjects in the study reported very high compliance during the study and a strong willingness to use the drug. We are very grateful to the investigators, their staff, and the study participants for their enormous efforts in this groundbreaking trial.”

Tenpoint cited that brimonidine also significantly improved reading speed and patient reported quality of life outcomes based on the NEI-Refractive Error Quality of Life questionnaire, in addition to no treatment related serious adverse events reported. Additionally, BRIMOCHOL PF demonstrated clinically and statistically significant reductions in pupil size at all timepoints. This reduction in pupil size was cited as a key mechanism of action for the miotic class of therapies creating a pinhole effect that correct for the loss of near vision and increases depth of focus.

While BRIMOCHOL PF accomplished correction of lost near vision and a depth of focus increase, distance vision improvements and gradual resolution of miosis over 10 hours was also recorded in the clinical trial. According to Tenpoint, less miosis later in the day may minimize difficulties concerning nighttime vision. Additionally, no tachyphylaxis was observed in either vision or pupil effects over the duration of the 12 month at-home dosing phase of the study.

“I am very pleased to see that BRIMOCHOL PF was not only well tolerated over a 12 month dosing study, but also achieved a functional improvement in reading speed, something that patients really care about,” said John Hovanesian MD, a member of Tenpoint’s Medical Advisory Board, in the release. “BRIMOCHOL PF has demonstrated a profile that, if approved, will meet the needs for a large proportion of presbyopes and I’m excited for the product to become a reality for patients.”

Further details from the study will be presented at upcoming scientific meetings, according to Tenpoint.

Tenpoint Therapeutics announces positive topline data from Phase 3 pivotal study, BIO-II, of BRIMOCHOL PF for the treatment of presbyopia. News release. Tenpoint Therapeutics. January 8, 2025. Accessed January 9, 2025.

The 3-arm, multicenter, randomized, double masked, safety and efficacy study successfully met pre-specified visual acuity primary endpoints with statistically significant near vision improvements recorded at all time points over 8 hours.

Maria K. Walker, OD, PhD

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