Oku Digital Health Launches From Topcon Healthcare to Accelerate Drug Development Using Ocular Data

Leveraging 17.1 Million Retinal Images and Point-of-Care Networks, Oku Connects Life Sciences Sponsors with Early-Stage, Treatment-Naïve Patients and Data for Drug Development

LA JOLLA, Calif., Oct. 06, 2026 (GLOBE NEWSWIRE) -- Oku Digital Health, Inc. today launched from Topcon Healthcare, bridging a connected network of more than 10,000 point-of-care locations directly with pharmaceutical development. Access to real-world ocular data helps sponsors identify treatment-naïve patients, accelerate clinical trials, and generate longitudinal real-world evidence across the drug development lifecycle.

Bringing a new drug to market can take more than a decade and, according to the Tufts Center for the Study of Drug Development, carries an estimated capitalized cost of approximately $2.6 billion per approved medicine.¹

But scientific discovery is only part of the challenge. Clinical development is also slowed by operational friction — complex eligibility criteria, patient recruitment, site performance, and fragmented data and clinical systems. These delays have real economic consequences. Recent Tufts research estimates that each day of delayed market entry represents approximately $800,000 in lost prescription drug or biologic sales on average — roughly $24 million per month.²

Turning Routine Eye Exams Into Clinical Trial Pipelines
Oku addresses these challenges by using ophthalmic data to accelerate drug discovery across ocular, cardiovascular, renal, metabolic, and neurodegenerative diseases. With U.S. patients living an average of nine miles from one of its sites, Oku’s Harmony solution turns routine eye exams into faster trial candidate identification, recruitment, better retention and scalable real-world evidence.

"Because eye exams happen every day at the point of care, they are a natural setting for opportunistic screening," said Matthew Lungren, MD, MPH, Chief Data AI Officer, Oku Digital Health, Inc. "Our multimodal AI models read OCT and fundus imaging alongside linked clinical data to identify signs associated with disease. Acting on these insights helps pharma sponsors advance drug development toward precision medicine by identifying ideal trial candidates, designing sharper protocols, and tracking longitudinal outcomes."

Oku’s AI-enabled clinical development and trial solutions include:

• Real-world data (RWD) and real-world evidence (RWE) access to de-identified clinical and imaging data: Oku offers longitudinal retinal imaging and linked clinical data across primary, specialty, and health-screening networks. AI-labeled and expert-annotated insights support biomarker development, trial design, adherence, post-market surveillance, and access claims.
• Point-of-care candidate identification and site finding services for clinical trials: Oku’s Harmony solution connects sponsors to treatment-naïve patients having routine eye exams, and helps pharma and surgical sponsors choose sites based on verified patient density.
• Expert AI-assisted Reading Center Services for clinical trials: Oku’s hybrid reading model combines AI and human expert reading to reduce variability, safeguard data integrity, and accelerate regulatory submissions for drugs and devices.
  
  

"Pharma sponsors face enormous pressure to identify the right patients faster and reduce screen-fails across fragmented trial workflows," said Trent Norris, Chief Operating Officer, Oku Digital Health, Inc. "Oku combines an AI development engine with proprietary and partner data to discover signals associated with disease, generate real-world evidence, and identify treatment-naïve patients directly at point-of-care."

Oku will make its debut at the American Academy of Ophthalmology (AAO) Annual Meeting in New Orleans, October 9 to 12, 2026. Attendees can meet the Oku team and explore its solutions within the Topcon Healthcare booth at AAO (1737). Learn more about the launch of Oku Digital Health here, and its provider solutions here.

Frequently Asked Questions

Q: How does Oku Digital Health assist pharmaceutical companies?
A: Oku provides life sciences sponsors with point-of-care patient identification services for clinical trials, real-world data (RWD) licensing, real-world evidence (RWE) generation, and expert AI-assisted Reading Center services for clinical trials.

Q: How does Oku Digital Health identify candidates for clinical trials?
A: Oku’s point-of-care AI algorithms analyze routine eye scans to detect early signs associated with disease to flag eligible, treatment-naïve candidates during routine primary care and comprehensive eye care visits.

Q: What datasets power Oku Digital Health’s Pharma Solutions?
A: Oku’s solution is built on 17.1 million retinal images, 1.2 million OCT volumes, and tokenized longitudinal EHR linkages across 14 health systems covering 146 million exams.

Q: How does Oku Digital Health protect patient data privacy and security?
A: Oku operates on Microsoft Azure cloud infrastructure with tenant isolation, end-to-end encryption, and components that have been certified to security standards including ISO 27001 and HITRUST. De-identified ocular imaging is linked to longitudinal EHR data through a secure tokenization framework that does not expose PHI.

About Oku Digital Health
Oku Digital Health, Inc. is an AI-powered digital health company headquartered in La Jolla, Calif., that connects eye insights to whole-body care. Launched from Topcon Healthcare, Inc. in 2026, Oku unites a connected network of more than 10,000 care locations, leverages Topcon’s global installed base of 50,000+ diagnostic devices, and has screened over 2.2 million patients outside of traditional eye care. Built on Microsoft Azure cloud infrastructure and optimized for AI workloads with NVIDIA CUDA libraries, Oku helps healthcare providers, researchers, and life sciences partners unlock the full clinical value of ophthalmic data.

Learn more at www.okuglobal.com

Forward-Looking Statements
This press release contains forward-looking statements, including statements about Oku's plans, products, technologies, business integration, and growth. Words such as "will," "expect," "anticipate," "intend," "may," and similar expressions identify these statements. They reflect Oku's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including risks related to regulatory clearance and oversight of Oku's products, the integration of recently combined businesses, Oku's ability to obtain and use data in compliance with law and contract, its commercial relationships with Topcon and other partners, market acceptance, cybersecurity and data privacy, and competition. Oku undertakes no obligation to update these statements, except as required by law.

Media Contact
Jamie Allyn
MERGE for Oku Digital Health, Inc.
OkuPR@mergeworld.com
www.okuglobal.com/in-the-news

Reference

1. DiMasi JA, Grabowski HG, Hansen RW. Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics. 2016;47:20-33. doi:10.1016/j.jhealeco.2016.01.012
2. Smith Z, DiMasi J, Getz K. Quantifying the Value of a Day of Delay in Drug Development. Tufts Center for the Study of Drug Development; 2024. Accessed September 29, 2026. https://csdd.tufts.edu/sites/default/files/2025-02/Aug2024%20Day%20of%20Delay%20White%20Paper%20Final.pdf?1742845518