Caravel Oculus Inc. today announced that its leading ophthalmic candidate, CA201A, has received approval from Australia’s Human Research Ethics Committee (HREC) and completed the Clinical Trial Notification (CTN) process with the Therapeutic Goods Administration (TGA). Marking a pivotal milestone in the company’s international expansion, Caravel Oculus has officially launched patient recruitment for this Phase II clinical trial.

Addressing Unmet Medical Needs in Post-Cataract Surgery Care

Cataract surgery is one of the most frequently performed ophthalmic procedures worldwide. However, the procedure often causes damage to non-regenerative corneal endothelial cells. Excessive corneal endothelial cell loss can lead to corneal edema, delayed visual recovery, and, in severe cases, the risk of requiring a corneal transplant.

CA201A was specifically developed by Caravel Oculus to protect the cornea following cataract surgery. The therapy aims to reduce post-operative loss of corneal endothelial cells, lower the risk of corneal edema and related complications, and accelerate visual recovery.

Dr. Chien-Hong Lee, Chairman of Caravel Oculus, stated:

“There has long been a lack of effective pharmaceutical interventions to protect corneal endothelial cells in clinical practice. After years of dedicated effort, our team leveraged our MDPF (Multi-Dose Preservative-Free) platform to successfully formulate CA201A as an ophthalmic solution. We aim to offer cataract patients a stable, user-friendly eye drop for both pre- and post-operative care, filling this long-standing unmet medical need.”

Global Clinical Strategy to Lay the Groundwork for International Licensing

The Phase II clinical trial in Australia will evaluate the safety, tolerability, and preliminary efficacy of CA201A in patients undergoing cataract surgery, tracking parameters such as corneal endothelial cell density, corneal edema, and visual acuity recovery.

Australia offers a well-established clinical trial ecosystem, world-class medical personnel, and a research environment aligned with international regulatory standards. Executing this trial in Australia will not only expand CA201A’s international clinical database, but also establish a solid foundation for subsequent global regulatory filings, cross-border licensing partnerships, and global market expansion.

Details regarding the trial design, eligibility criteria, and primary endpoints have been registered on ClinicalTrials.gov under identifier NCT07694375: https://clinicaltrials.gov/study/NCT07694375

Caravel Oculus remains dedicated to addressing key unmet needs in ophthalmology, accelerating the clinical pipeline of its innovative therapies, and delivering safer, high-value clinical options to patients globally.

About Caravel Oculus Inc.

Caravel Oculus Inc. is a biopharmaceutical company focused on the development of innovative ophthalmic therapeutics. The company concentrates on addressing high unmet medical needs in eye care by advancing its product pipeline through clinical development, aiming to offer safer and clinically meaningful treatment options to patients worldwide. For more information, please visit www.caraveloculus.com.

Media Contact

• Contact Person / Title: Bonnie Tsai / CFO
• Email: service@caraveloculus.com