• Regeneron released a statement in response to a complaint that was filed by the U.S. Department of Justice (DOJ) under the False Claims Act against the company that alleges that it misreported the Average Sales Price (ASP) for Eylea (aflibercept) Injection 2 mg by not taking into account credit card service fees incurred by its distributors and reimbursed by Regeneron. In the statement, Regeneron said it “believes the complaint is meritless and illustrates a fundamental misunderstanding by the DOJ of drug price reporting standards. Regeneron will vigorously defend this case in court. The filing of this lawsuit will not change our practices with respect to reimbursement of credit card fees incurred by our distributors. Reimbursing credit card service fees to distributors is not a price concession and does not affect Eylea’s price. Congress has provided by statute how to calculate ASP. The statute requires manufacturers to include a specific list of price concessions in ASP. Credit card service fees are not included on that list. The Centers for Medicare & Medicaid Services has not exercised its rulemaking authority to define credit card service fees as a price concession under the statute.” Regeneron adds that Bona Fide Service Fees are not included in ASP per applicable statute and regulation. The company says it is reimbursing distributors for credit card service fees incurred by the distributors performing services on Regeneron’s behalf, and such fees are thus Bona Fide Service Fees that do not reduce the ASP for a drug. 

• iHealthScreen Inc. was awarded a US patent for its iPredict glaucoma detection model. iPredict provides a fully automated detection report for glaucoma that can be implemented in primary care settings for screening and detection of early-stage glaucoma. Once high-resolution images of the patient’s eyes/retina have been captured using a color fundus camera and submitted to the iPredict AI System, the glaucoma detection results are available in a fully automated report in less than 60 seconds. The entire test — which includes color retinal imaging and the automated AI-based glaucoma report generation — can be completed within 5 minutes. iPredict-glaucoma report will indicate referable (ie, early to severe glaucoma) or non-referable glaucoma (not glaucoma). For referable glaucoma subjects, patients will be referred to a glaucoma specialist.

• Dr. David F. Chang presented the first-of-its-kind robotic cataract procedure on a porcine eye  at the ASCRS Annual meeting, marking the debut of this technology at a conference. During his Charles D. Kelman Innovator Lecture, Dr. Chang discussed his experience using ForSight Robotics’ ORYOM Surgical Robotics Platform to perform a complete, remote robotic cataract procedure. He presented a video of the procedure and discussed the future potential for this technology. ORYOM is being developed to amplify surgeons’ skills and to increase patient access to sight-saving surgery, worldwide. Utilizing AI-based algorithms, robotics and advanced computer vision, the ORYOM Platform has already completed dozens of full robotic cataract procedures (on an animal eye model). 

• Sight Sciences announced the results of a large scale, comparative real-world clinical outcomes study of patients treated by three leading, minimally invasive glaucoma surgery (MIGS) technologies. Using the AAO IRIS Registry, the study evaluated long-term 2-year post-surgical outcomes among patients with primary open-angle glaucoma treated with three commonly used FDA-approved/cleared ab interno MIGS devices in the United States combined with cataract surgery, as well as for cataract surgery alone. At 24 months, high baseline IOP (>18 mm Hg) patients who received the outflow procedure using OMNI Surgical System had the greatest numerical reduction in IOP and the greatest numerical reduction in medication use. Additionally, at 24 months, low baseline IOP (≤18 mm Hg) patients who received the outflow procedure using OMNI technology had the greatest numerical reduction in IOP and a statistically significantly greater mean medication use reduction compared to all other treatment groups. For more, see the study results here. 

• Orbis and Heidelberg Engineering are providing free clinical education for physicians around the world. In 2024, Heidelberg Engineering is sponsoring three instructional virtual sessions, taking place via Cybersight, the telemedicine and e-learning platform founded by Orbis. The targeted clinical educational sessions will guide physicians in how OCT, and other technological advances, can be used to detect, treat and prevent common causes of sight loss, like cataract, glaucoma, diabetic retinopathy and corneal disease. The free webinars can also be accessed in the Cybersight Library after the sessions have taken place. The first session - Improved Perioperative Management of Cataract Surgery Using OCT Technology - took place on April 12. The next two sessions are scheduled on July 19 at 1:00 p.m. UTC - Using OCT as an Approach to Diagnose Glaucomatous and Other Optic Neuropathies and November 15 at 2:00 p.m. UTC - Clinical Technology & Surgical Techniques in the Evolving Management of Corneal Diseases. 

• Ocuphire Pharma announced the enrollment of the first subject in the LYNX-2 Phase 3 registration study evaluating phentolamine ophthalmic solution 0.75% for the treatment of decreased visual acuity under low (mesopic) light conditions following keratorefractive surgery. The LYNX-2 trial is being conducted under conditions of a Special Protocol Assessment with the FDA. As previously announced, Ocuphire received written agreement from the FDA that the clinical trial protocol and planned statistical analysis of the LYNX-2 Phase 3 trial would adequately address objectives supporting regulatory submission and a potential future marketing application in this indication.

• A new EU research project called I-SCREEN will help with early detection of AMD. The I-SCREEN project will pioneer an AI-based program to identify and monitor AMD at its earliest stages. Utilizing the precision of AI, the project aims to revolutionize AMD care by introducing an AI-powered platform compatible with optical coherence tomography (OCT) scanners found in optometry practices. This approach will empower primary care optometrists to diagnosis AMD earlier and facilitate more timely treatment by efficient referrals. The researchers will recruit a cohort of patients with intermediate AMD to follow for 2 years to identify the earliest stage of transition to late AMD, which will help refine the AI models that could be used in the community.

• A recently published paper in Psychodynamic Psychiatry reveals the importance of understanding how mental and physical health can affect each other in people with vision loss. The paper, titled, “Psychodynamic Psychiatry and the Care of Persons with Vision Loss and Blindness,” discusses how an approach that considers the emotions and experiences of individuals who are visually impaired can aid in dealing with challenges they may face, such as depression, anxiety and negative self-perceptions. Since persons with vision loss have an increased risk of depressive and anxiety disorders, the authors recommend targeted screening, integrated services and a biopsychosocial approach to clinical care. Common psychotherapy themes in the treatment of persons who experience vision loss from systemic illness include reactivation of memories of past traumas resulting in avoidance, social withdrawal, depressive states, catastrophic thinking, a sense of foreshortened future, anhedonia, and fear of disintegration and invisibility. 

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.