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The US Food and Drug Administration (FDA) has approved an expanded label for fluocinolone acetonide intravitreal implant (ILUVIEN) that includes an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). In addition to the expansion of this label, the approval includes updates to the label including to the Warnings and Precautions section. This treatment is already approved for both diabetic macular edema (DME) and NIU-PS outside the US, including in 17 European countries.

ANI previously announced that it extended its supply agreement for ILUVIEN with a subsidiary of Siegfried Holding AG (Seigfried) through 2029. Siegfried and ANI also agreed to upgrade equipment on the existing manufacturing line and significantly expand capacity.

ILUVIEN is a corticosteroid indicated for:

the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.

the treatment of chronic NIU-PS of the eye.

with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases;

with glaucoma who have cup to disc ratios of greater than 0.8;

with known hypersensitivity to any components of this product.

Additional information on safety information and adverse events can be found in the company press release.

1. ANI Pharmaceuticals Announces FDA Approval for Expansion of ILUVIEN® Label. ANI Pharmaceuticals, Inc. March 14, 2025. Accessed March 18, 2025. https://www.globenewswire.com/news-release/2025/03/14/3042856/0/en/ANI-Pharmaceuticals-Announces-FDA-Approval-for-Expansion-of-ILUVIEN-Label.html

This treatment is already approved for both diabetic macular edema (DME) and NIU-PS outside the US, including in 17 European countries.

clinical

Canonical

FDA approves expanded label for fluocinolone acetonide intravitreal implant

Diagnos Inc. will file for US Food and Drug Administration (FDA) pre-market authorization of its CARA SYSTEM. This is a machine-learning-enabled medical device (MLMD) that is designed to assist optometrists and frontline healthcare professionals in analyzing fundus images for the early detection of diabetic retinopathy, age-related macular degeneration, and hypertensive retinopathy.

To ensure a smooth regulatory process, DIAGNOS has engaged ORA, a leading clinical research organization specializing in regulatory affairs and clinical development for ophthalmic products. ORA will play a pivotal role in navigating the US regulatory landscape and ensuring a successful FDA submission process.

André Larente, CEO of Diagnos, shared his thoughts on this milestone in the company’s growth in the news release

, saying, “Diagnos is committed to revolutionizing eye health through Artificial Intelligence technologies. Our expertise in Artificial Intelligence driven diagnostics is helping to improve patient outcomes worldwide. The optometry market comprises over 300,000 sites globally, and our recent partnership with the largest player in the industry will significantly boost our visibility. Additionally, our government-related business initiatives are resuming, marking an exciting phase of growth for Diagnos.”

Diagnos Inc. is headquartered in Brossard, Canada.

1. DIAGNOS to File for FDA Pre-Market Authorization of Its AI-Powered CARA SYSTEM and Engages Ora as Regulatory Specialist. Diagnos Inc. February 25, 2025. Accessed February 27, 2025. https://www.globenewswire.com/news-release/2025/02/25/3032119/0/en/DIAGNOS-to-File-for-FDA-Pre-Market-Authorization-of-Its-AI-Powered-CARA-SYSTEM-and-Engages-Ora-as-Regulatory-Specialist.html

This device is designed to assist healthcare professionals in analyzing fundus images for the early detection of key retinal conditions.

Diagnos Inc to submit FDA pre-market authorization for CARA SYSTEM

AEYE Health and Topcon Healthcare, Inc., are sharing results of the combination of Topcon's NW500 non-mydriatic retinal camera and AEYE Diagnostic Screening (AEYE-DS). Together, these technologies demonstrated exceptional efficacy and unprecedented 100% imageability, which may set a new standard for accessible, on-the-spot patient care.

The companies noted in their shared press release

 that a recent study of AEYE-DS AI technology used in conjunction with the Topcon NW500 resulted in exceptional clinical diagnostic efficacy of 92% sensitivity and 90% specificity. The study also saw unprecedented imageability with 100% of patients receiving diagnostic results, and greater than 99% of participants successfully imaged on the first attempt without dilation.

Zack Dvey-Aharon, PhD, CEO of AEYE Health shared his thoughts on this milestone, saying, “With Topcon's NW500, we were able to achieve 100% imageability and virtually 100% success rate on the first attempt without dilation. This means all patients can be screened on the spot, ensuring no one is left out of this critical diagnostic opportunity. This amazing advancement will significantly increase adoption of AI screening in the US and around the world."

Similarly, Ali Tafreshi, CEO & President of Topcon Healthcare, Inc. is also quoted in the release

 regarding the future steps, saying, "To successfully scale DR screening for all patients, robotic and high-quality imaging combined with a robust AI algorithm is essential. The NW500 with AEYE-DS will empower primary care providers to improve patient outcomes and enhance adherence to diabetic retinopathy screenings. It is another significant milestone in delivering Healthcare from the Eye."

AEYE-DS is already FDA-cleared for use with Topcon's TRC-NW400 and can be accessed through the Harmony digital health platform. AEYE Health is seeking additional clearance for its autonomous screening solution in combination with the Topcon NW500. AEYE-DS is the only approved autonomous AI solution that requires a single image per eye and, with the NW500, does not require dilation therefore significantly improving the time to screen patients to under one minute.

1. AEYE Health in partnership with Topcon Healthcare, Inc, Announces Exceptional Usability and Clinical Efficacy for Autonomous Diabetic Retinopathy Screening. AEYE Health. February 12, 2025. Accessed February 13, 2025. https://www.prnewswire.com/news-releases/aeye-health-in-partnership-with-topcon-healthcare-inc-announces-exceptional-usability-and-clinical-efficacy-for-autonomous-diabetic-retinopathy-screening-302374944.html

A recent study of AEYE-DS AI technology used in conjunction with the Topcon NW500 resulted in exceptional clinical diagnostic efficacy.

Companies' results of the combination of Topcon's retinal camera and AEYE Diagnostic Screening

Heart Eye Diagnostics Limited, based in the UK, announced a new tool for cardiovascular disease (CVD) risk assessment using retinal imaging. Dr Noon CVD uses artificial intelligence (AI) to detect and predict future cardiovascular risks. The noninvasive system uses retinal imaging rather than traditional predictive tools, such as blood sampling, CT scans or carotid ultrasounds.

According to a press release from Heart Eye, the retinal-based AI algorithm exhibits the same degree of accuracy as heart CT scans. The technology is being further developed to provide information on other systemic health factors, such as kidney function, using other ocular biomarkers.

The device’s deep-learning algorithm is validated on a global cohort to match the predictive performance of heart CT scans. The design is intended to be scalable and cost-effective, expanding access to patients who may be otherwise unable to undergo scans for CVD risks.

In the press release, Dr Husain Khaki, the director of Heart Eye, described potential applications for the device. “Traditional methods like heart CT scans come with a lot of drawbacks for mass screening including high radiation doses, long wait times and expensive costs. This technology helps lower healthcare costs by catching potential issues early and preventing strokes and heart disease before they become serious,” he said.

Dr Khaki also noted that early, accurate diagnosis represents “a breakthrough” for patients with CVD or at risk of CVD. He praised the speed of the screening tool.

“The fact that results are available in just three minutes is a game-changer for opticians, hospitals and primary care providers,” Dr Khaki said. “It means they can act quickly with preventative care, which leads to better outcomes for patients.”

Heart Eye will offer free cardiovascular disease risk retinal scans using Dr.Noon CVD at two upcoming meetings in the UK: 100% Optical, which runs from 1-3 March at ExCeL in London, and Optix Conference, which runs from 17-19 March at The Celtic Manor in Wales.

World’s First AI-Powered Cardiovascular Retinal Screening to be launched in the UK. News release. Heart Eye Diagnostics LTD. Published February 19, 2025. Accessed February 19, 2025.

The UK-based company will debut the tool, called Dr.Noon CVD, at two conferences in March

Heart Eye announces AI-driven retinal imaging system to detect biomarkers of cardiovascular health risks

A study conducted at major Ophthalmology departments across the US found that the rates of sexual harassment in the specialty, which were high when a previous survey was conducted, remained high 5 years after those high rates were disclosed, with higher frequencies of recent experiences and continued low reporting rates,

 according to Olivia J. Killeen, MD, MS, and colleagues. She is from the Department of Ophthalmology, Duke University, Durham, NC, and the Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor.

Killeen was joined in this study by colleagues from the Department of Ophthalmology, University of Washington, Seattle; the Department of Pediatrics, Duke University; the Department of Ophthalmology, Weill Cornell Medicine, New York; and the Division of Ophthalmology, Seattle Children’s Hospital, Seattle.

The investigators had a dual goal: to compare the rates and characteristics of sexual harassment in ophthalmology reported in 2018 to those described in 2023 and to investigate the rates of gender discrimination among the 2023 respondents. They conducted a cross-sectional, observational survey study using Google Forms through the Women in Ophthalmology email blast list from August 25 to September 25, 2023. The main study outcomes were the rates of sexual harassment, number of occurrences during the past 5 years, and gender discrimination, they recounted.

Killeen and colleagues reported that 1,051 emails containing the survey were sent; of the 692 (65.8%) that were opened, 289 were eligible participants who responded, for a response rate of 27.5% of the emails initially send. Almost 40% of participants were from 31 to 40 years of age.

“Of the 289 survey respondents in 2023, 172 (59.5%) experienced sexual harassment in ophthalmology compared with 265 of 447 (59.3%) surveyed in 2018 (difference, 0.2%; 95% confidence interval, −7.0% to 7.5%; 

More respondents in 2023 experienced sexual harassment compared with 2018, ie, 62.2% versus 47.2% (

 < 0.001). The investigators also found that in 2023, 24.1% reported their most severe experience to an authority compared with 15.1% in 2018 (

 = 0.02). Of 287 survey respondents in 2023, 85.0% experienced gender discrimination.

In commenting on their findings, the authors said, “In this survey study, the rates of sexual harassment among respondents remained high 5 years after a survey on sexual harassment in ophthalmology, with a higher frequency of recent experiences and continued low reporting rates. With other forms of gender discrimination also highly prevalent among respondents, these results support pursuit of validated strategies to foster a culture of zero tolerance toward harassment and discrimination.”

1. Killeen OJ, Ding L, Enyedi L, Sun G, Cabrera MT. Sexual harassment in ophthalmology. 

Published online February 20, 2025. doi: 10.1001/jamaophthalmol.2024.6489

Sexual harassment remains high in ophthalmology

The American Academy of Ophthalmology (AAO) is holding its annual meeting October 18 to 21 at McCormick Place in Chicago, Illinois, featuring symposia, instruction courses, clinical sessions, original papers, skills transfer lectures, videos and posters, and the Expo.

According to Debra Rosencrance, vice president of meetings and exhibits at the AAO, the theme for AAO 2024 is “elevate.”

“The academy’s annual meeting helps attendees elevate their skills, knowledge, and the profession,” she explained. “We encourage physicians to bring their entire team to the annual meeting as there are sessions and networking opportunities that can elevate one’s entire practice.”

A new addition this year is the Saturday Night Celebration, being held from 7:30 PM to 10:30 PM on October 19. Rosencrance noted that it is a new meetingwide event supporting the academy’s education initiatives. Attendees can buy tickets through registration.

Rosencrance added that more educational opportunities are now available in the AAO 2024 Expo.

“In addition to the sessions taking place in the Learning Lounge and Poster Theater, industry will talk about products and trends in the Showcase Theater,” she pointed out. “Exhibitors from early-stage and start-up companies will speak in the new Innovation Theater, and academy education, advocacy, and research initiatives will be highlighted in the new Academy Theater.”

During the meeting there will be a range of educational opportunities available, including hands-on workshops and certification courses, with an educational opportunity for everyone, regardless of their learning style. Rosencrance noted that these include the following:

Small-group learning at the Learning Lounge, Academy Café, Poster Theater, Poster Discussions, new Innovation Hub, and more.

Hands-on surgical labs allow attendees to practice a new technique or brush up on an old one.

Symposia rooms allow attendees to listen to ophthalmology’s key opinion leaders on the latest research and then immediately discuss with nearby colleagues during the breaks.

There are several keynote speakers lined up for the event, including the following:

Jasmine H. Francis, MD, will deliver the Jackson Memorial Lecture. The title of her presentation is “Histiocytosis Advancements Parallel Ophthalmic Innovation.”

Mary Street Alinder will deliver the Michael F. Marmor Lecture in Ophthalmology and the Arts with a presentation titled “Ansel Adams: The Development of Vision.”

Rosencrance pointed out that there are several must-attend sessions on the schedule this year. New sessions and hot topics include Office-Based Surgery; Ophthalmology Mythbreakers; The Year in Literature: Editor’s Choice Highlights From the Ophthalmology Journal Family; Artificial Intelligence in Ophthalmology; Geographic Atrophy; New Retinal Therapies; and New Therapies for Corneal Endothelial Diseases.

“We encourage attendees to stay for Cataract Monday, the academy’s must-attend Spotlight on Cataract Complications,” she added.

The primary objectives for planners this year, according to Rosencrance, have been to provide more networking and educational opportunities in the Expo and to develop programs for the entire practice team.

“We continue to look for ways to make the meeting more comfortable for attendees,” she added. “One way we are addressing this at this year’s meeting is the introduction of a quiet room. We’ll be providing a room away from the action where attendees who may be feeling a little overwhelmed can sit quietly to read, work, or relax.”

Each year, the academy sets out to make the event a little different.

“AAO attendees will find something different every year because the program is based on what is hot in ophthalmology right now,” Rosencrance explained. “We are continually tweaking the educational opportunities to continue offering value to all attendees.”

Rosencrance also pointed out that Chicago remains a favorite destination for the academy.

“It is easy to travel to and from the city, and there is always something new to see, hear, and experience,” Rosencrance said. “It is known for its cutting-edge theater, breathtaking architecture, world-renowned museums, and inventive chefs.”

The academy will also provide myriad ways for ophthalmologists to network during the annual meeting.

“We have been creating more and more business-ready networking lounges designed for attendees to conduct meetings and interviews, charge devices, check in with the office, focus, and relax,” Rosencrance pointed out. “We’ve added more educational opportunities to interact and discuss in small groups—Learning Lounge, Academy Café, poster discussions, and introducing ‘continue the conversation’ areas in selected session rooms.”

Rosencrance added that attendees are encouraged to take advantage of regularly scheduled breaks in the scientific program to meet up with colleagues and mentors, visit affinity group lounges, and explore the AAO 2024 Expo.

“The new Saturday Night Celebration is a great place to connect with friends and colleagues, meet academy leadership, and just have fun at one of Chicago’s hottest nightclubs, TAO,” she added.

The academy also will offer both in-person and virtual options for AAO 2024 and Subspecialty Day.

American Academy of Ophthalmology offers in-person and virtual options for annual meeting, Subspecialty Day.

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