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The supplemental BLA seeks approval for Eylea HD for both the treatment of macular edema following retinal vein occlusion, and for broadening the dosing schedule to include every 4-week dosing across approved indications.

Regeneron’s sBLA for Eylea HD accepted for priority review by FDA

Dr. Gaddie is also executive vice president of the Optometric Glaucoma Society and co-chair of International Vision Expo meetings. Dr. Gaddie serves as a consultant to ScienceBased Health.

0820 4196 Ben Gaddie.jpg

Inflammation is both a cause and consequence of dry eye disease.

Addressing the root cause of dry eye disease

The VLP system, engineered nucleocytosolic vehicle for loading of programmable editors (ENVLPE), was found to have corrected 2 mutations associated with blindness.

Researchers develop virus-like particle to edit proteins causing inherited eye diseases

The program also offers eligible students with an in-school commitment to hire them after graduation and provides support for federal and private loans.

EyeCare Partners and Clasp partner to create a new student loan repayment program for eye care providers 

The leading source of breaking news, news analysis, and emerging research reports in optometry, Optometry Times® disseminates practical content by optometrists for optometrists that can be immediately applied to improve the clinical experience.

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Fasting regimens have gained popularity as a technique for reducing weight and obesity. This strategy may improve insulin sensitivity in patients with insulin resistance and diabetes.

Fasting regimens may be key in treating type 2 diabetes

Recently, a colleague wrote me to express his concern about a primary care physician (PCP) in his community acquiring digital retinal photographs of his diabetes patients. One of those patients presented to the optometrist’s office with the impression that “all he needed was a refraction” since the PCP had “already checked him for diabetic retinopathy.”

The importance of multidisciplinary care for diabetes

Opthea announced its intention to lay off approximately 65% of the company in a corporate update filed with the US Securities and Exchange Commission (SEC).

This news follows the announcement from Opthea that it plans to discontinue its COAST and ShORe trials in 

wet age-related macular degeneration (AMD)

COAST trial failed to meet its primary end point.

The company stated that “a limited number of employees will remain in place to ensure the compliant termination of clinical trial activities and oversee administration operations.”

Fred Guerard, PharmD, CEO of Opthea, commented on the news in the SEC release, saying, “Following the negative phase 3 trial results and in consultation with the company’s Development Funding Agreement (DFA) investors, the board has concluded that it is in the best interest of our investors to conserve cash. We are grateful for the numerous contributions of our colleagues leaving Opthea and wish them the best for their future endeavors.”

The company stated that the layoffs are expected to take effect on May 1, 2025, and that one-off costs associated with the reduction in force are expected to be approximately $4.5 million. Overall, the layoffs will result in a reduction in monthly employee costs of approximately $1 million, according to the company.

Opthea estimates unaudited cash and cash equivalents of $100 million as of March 2025. Opthea remains in active negotiations with its DFA investors, “pursuant to and as required under the DFA, to explore possible options to deliver the best outcome for the company and its shareholders.”

As previously reported, Opthea is currently relying on the "safe harbor" provisions in section 588GA of the 

 (Cth), and trading in Opthea’s listed securities will be suspended by ASX under ASX Listing Rule 17.3 until the company is in a position to provide an announcement to the market providing more clarity on these issues and the impact on its financial position.

Opthea Provides Corporate Update. Published April 10, 2025. Accessed April 10, 2025. 

https://www.sec.gov/Archives/edgar/data/1815620/000095017025052661/opt-ex99_1.htm

Harp M. Opthea discontinues COAST and ShORe trials in wet AMD. Ophthalmology Times. Published March 31, 2025. Accessed April 10, 2025. https://www.ophthalmologytimes.com/view/opthea-discontinues-coast-and-shore-trials-in-wet-amd

Harp M. Opthea phase 3 clinical trial, COAST, in patients with wet age-related macular degeneration fails to meet primary endpoint. Ophthalmology Times. Published March 24, 2025. Accessed April 10, 2025. https://www.ophthalmologytimes.com/view/opthea-phase-3-clinical-trial-coast-in-patients-with-wet-age-related-macular-degeneration-fails-to-meet-primary-endpoint

The announcement follows the decision to discontinue the COAST and ShORe trials in wet age-related macular degeneration after the COAST trial failed to meet its primary end point.

Canonical

Opthea to lay off 65% of company following announcement of clinical trial discontinuation

This quiz accompanies THIS article from our November issue

Quiz: Treatments for presbyopia coming soon

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

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.

A. Paul Chous, MA, OD, FAAO

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