Raytone Biotech, a clinical-stage biotechnology company focused on innovative ophthalmic therapies, announced the successful dosing of the first patient with RTP-008 during Q2 2025. The milestone was achieved at Beijing Tongren Hospital, Capital Medical University, marking a significant step forward in addressing the complex treatment challenges of moderate-to-severe dry eye disease (DED).
The trial was conducted by Professor Ying Jie, Director of the Ophthalmology Center, and Professor Lei Tian, Deputy Director of the Ophthalmology Center. The first enrolled patient, diagnosed with moderate-to-severe DED, tolerated the procedure well with no significant adverse reactions observed post-administration.
Addressing Complex Treatment Challenges
Dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, accompanied by ocular symptoms. Tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles in the condition.
Current clinical approaches include physical interventions such as punctal occlusion and pharmacological therapies including artificial tears and anti-inflammatory agents. For patients with moderate-to-severe DED, treatment typically requires combination therapies. Many patients rely on two to three topical ophthalmic agents administered multiple times daily, a regimen that often leads to poor patient compliance due to its complexity.
This treatment complexity may result in incomplete treatment courses, perpetuating a "remission-relapse vicious cycle." Breaking this cycle demands therapies that provide symptomatic relief and address underlying pathophysiology, coupled with patient-centric treatment modalities to improve patient compliance.
Dual-Mechanism Innovation
RTP-008, developed based on Raytone Biotech's iSus® bioabsorbable sustained-release drug delivery platform, is designed to address the complexities of dry eye disease through a dual mechanism of action targeting two key pathological aspects:
Physical Tear Retention: The hydrogel-based plug rapidly swells upon insertion into the lacrimal canaliculus, forming a stable physical occlusion that reduces tear drainage and prolongs tear retention on the ocular surface.
Sustained Anti-inflammatory Effect: Tacrolimus, a potent anti-inflammatory agent, is released continuously into the tear film, dispersing across the ocular surface to suppress chronic inflammation. The plug's physical presence extends drug retention time, creating a self-reinforcing therapeutic loop.
The iSus® platform utilizes advanced polymer-drug composite technology to achieve precisely controlled drug release for weeks to months following a single administration. A single administration of RTP-008 can maintain therapeutic efficacy for several months, significantly improving patient compliance.
Clinical Outlook
Professor Ying Jie and Professor Lei Tian, Principal Investigators of the trial, commented, "RTP-008 demonstrated promising efficacy and safety profiles in preclinical animal studies. The favorable tolerability observed in the first patient is an encouraging signal. We will closely monitor the patients and look forward to demonstrating robust clinical efficacy."
Dr. Yanbo Ling, CEO of Raytone Biotech, stated, "We extend our gratitude to Professor Ying Jie and Professor Lei Tian's team for their professional collaboration, which ensured the successful first patient dosing. This milestone marks our transition from preclinical development to clinical trials, opening new possibilities for patients with moderate-to-severe dry eye. We hope our efforts will ultimately bring meaningful benefits to patients in need."
Company Development Strategy
Founded in 2021, Raytone Biotech specializes in ocular bioabsorbable sustained-release technologies, dedicated to addressing clinical challenges associated with traditional eye drops such as frequent dosing and low bioavailability. The company is dedicated to driving the transformation of ophthalmic treatment towards a "long-lasting and precise" model.
Beyond RTP-008, Raytone will research and develop other ocular drug-device combination products in parallel, while extending its mature products into the field of pet healthcare, bringing benefits to people with eye diseases worldwide.
