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Investigational pipeline provides promise for an unmet need.

Emerging treatments for advanced dry AMD

The role of oxidative stress in DME

Formosa Pharmaceuticals and Cipla Limited have entered into an exclusive licensing agreement for the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007) for post-operative inflammation and pain following ocular surgery.

Under the terms of the agreement, Cipla has exclusive rights to market APP13007 across 11 countries: India, Nepal, Sri Lanka, Bangladesh, Malaysia, Myanmar, Kenya, Nigeria, South Africa, Argentina, and Colombia.

approved by the US Food and Drug Administration (FDA) in March 2024

. It offers a twice-daily dosing regimen for 14 days without tapering, providing rapid and sustained relief from inflammation and pain.

 The rights to APP13007 have been split depending on the country, with numerous deals being made, and the deal with Cipla adds to the list.

 to the drug in August 2023 from Formosa. 

Cristália Products Químicos Farmacêuticos LTDA acquired exclusive Brazilian rights

 from Formosa in January 2024. In Canada, 

Apotex Inc. acquired exclusive rights in August 2024

Erick Co, president and CEO of Formosa Pharmaceuticals, and Achin Gupta, global chief operating officer of Cipla, both commented on the recent partnership in a press release.

"Formosa Pharma welcomes this partnership with Cipla, a well-renowned and respected global pharmaceutical brand. We appreciate their recognition and desire to add APP13007 to their rich portfolio of innovative medicines and look forward to working together to provide our novel therapy to ocular surgery patients to their audience," said Co.

"The partnership with Formosa Pharmaceuticals marks a significant milestone for Cipla, as it is our first multi-regional licensing agreement in ophthalmology. It reinforces our commitment to bringing cutting-edge treatments to patients worldwide. With exclusive rights to market APP13007 across 11 countries, we are excited to expand access to this innovative therapy and strengthen our ophthalmology portfolio,” said Gupta.

The strategic licensing agreement between Cipla and Formosa Pharmaceuticals includes upfront payments, royalty milestones, and additional value-driven considerations throughout its term.

Cipla and Formosa sign multi-regional licensing deal for Clobetasol Suspension. PRnewswire. Published March 18, 2025. Accessed March 20, 2025. 

https://www.prnewswire.com/news-releases/cipla-and-formosa-sign-multi-regional-licensing-deal-for-clobetasol-suspension-302403405.html

The recent agreement with Cipla adds to the list of partnerships Formosa has formed for APP13007.

Canonical

clinical

Formosa Pharmaceuticals enters into licensing agreement with Cipla for commercialization of APP13007 across 11 countries

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.

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

David S. Boyer, MD

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