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The survey results included 11,412 patients in the general population and 964 health care providers.

Global survey reveals health care provider, patient confidence in AI and medical technology

Leos is supported by emerging data from a randomized controlled clinical trial, further validating its safety and efficacy.

BVI Medical receives 510(k) clearance FDA for laser endoscopic surgical system for glaucoma

The affected mandate requires that all newborns receive erythromycin ointment applied to their eyes after birth, which helps prevent ophthalmia neonatorum.

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

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

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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Tools help to address multifocal contact lens fitting challenges

Global ophthalmic device company BVI Medical has announced the completion of its $1 billion strategic capital raise in partnership with global alternative asset management firm TPG. The investment fully refinanced BVI’s existing debt and added new equity from both TPG and new investors.

 The company plans to continue substantial growth in its portfolio of product offerings in light of the investment, according to a news release.

“This investment marks a pivotal moment for BVI as we scale our capabilities to meet the rising demand for advanced ophthalmic solutions,” said Shervin Korangy, president and CEO of BVI, in the release. “We are redefining the future of eye surgery and changing the competitive landscape by driving the launch of breakthrough technologies that will empower surgeons worldwide.”

Of recent note, BVI expanded its IOL manufacturing to Europe in order to meet global product demand, introduced new product lines including SERENITY and SERENITY Toric premium monofocal IOLs,

 and has engaged in a number of strategic acquisitions. Additionally, the company launched an education platform for ophthalmologists earlier this year, which allows physicians to connect across specialties to share insights and address complex cases.

“TPG is proud to continue our partnership with BVI as it works to scale its global impact in ophthalmic care,” said Kendall Garrison, Partner at TPG. “The company has strengthened its market position while advancing patient care worldwide and this investment will further drive innovation and expansion. We look forward to supporting BVI’s continued success,” added John Schilling, MD, Co-Managing Partner at TPG Capital.

BVI Medical secures strategic capital raise to fuel global growth and innovation. News release. Businesswire. March 10, 2025. Accessed March 12, 2025. 

https://www.businesswire.com/news/home/20250306731225/en/BVI-Medical-Secures-Strategic-Capital-Raise-to-Fuel-Global-Growth-and-Innovation

Joy J. BVI to launch new SERENITY and SERENITY Toric monofocal IOLs. 

September 5, 2024. Accessed March 12, 2025. 

https://www.optometrytimes.com/view/bvi-to-launch-new-serenity-and-serenity-toric-monofocal-iols

BVI Medical launches educational platform for ophthalmology professionals. News release. News release. BVI Medical. January 31, 2025. Accessed March 12, 2025. 

https://www.bvimedical.com/us/bvi-medical-launches-educational-platform-for-ophthalmology-professionals/

The capital raise was completed in partnership with global alternative asset management firm TPH.

BVI Medical completes a $1 billion strategic capital raise

EyeCare Partners has partnered with recruitment platform Clasp in order to establish a new student loan repayment program to aid in the attraction and retention of eye care providers.

 The program, EyeRise, also provides eligible students with an in-school commitment to hire them after graduation, according to a news release.

“We are driven by the belief [that] together we can bring the absolute best eye care to communities across the US,” said Billy Parsons, chief human resources officer at EyeCare Partners, in the release. “Through this program, we aim to empower optometry and ophthalmology students to focus on their education and future eye care careers without the financial stress that often accompanies their journey.”

Additionally, the program also provides support for federal and private loans, offering comprehensive financial relief for students.

 For optometrists, up to $45,000 to $100,000 in student loan repayment benefits are available over 3 to 4 years of employment. The amount of relief available is dependent on work location, and is offered in 3 tiers. Tier 1 provides up to $100,000 for a 4-year commitment, tier 2 is up to $75,000 for a 4-year commitment, and tier 3 is up to $45,000 for a 3-year commitment. Applying to the program requires a phone recruiter interview, phone interview with the medical director or practice administrator, and a site visit.

Once a student has submitted an application and is selected for the program and hired by a practice, EyeCare Partners will repay the select amount of loans over a set period of future employment in accordance with the terms of the loan repayment agreement. Selected students will sync their eligible federal or private education loans on the Clasp platform. Additionally, after graduation and licensure, the student will join EyeCare Partners as a full-time hire.

“Clasp is proud to support EyeCare Partners in their commitment to addressing eye care workforce shortage in health care,” said Tess Michaels, founder and CEO of Clasp. “This program not only provides immediate financial relief for students but also builds long-term retention and engagement, creating a sustainable talent pipeline.”

Eligibility criteria and application submission information are available on Clasp’s 

EyeCare Partners announces new student loan repayment program to attract and retain optometrists and ophthalmologists. News release. EyeCare Partners. April 15, 2025. Accessed April 15, 2025.

Optometry students: Your optometry career, backed by EyeCare Partners. EyeCare Partners. Accessed April 15, 2025. 

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 

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.

Nick Gidosh, OD, FAAO

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