Raytone Biotech Announces First Patient Dosed in Clinical Trial of RTP-008 for Dry Eye Disease

BEIJING, Aug. 3, 2025 /PRNewswire/ -- Raytone Biotech, a clinical-stage biotechnology company dedicated to innovative ophthalmic therapies, announced that it successfully completed the first patient dosing in its clinical trial of RTP-008 during Q2 2025. RTP-008 is a bioabsorbable tacrolimus lacrimal canaliculus plug for the treatment of dry eye disease (DED). The milestone was achieved at Beijing Tongren Hospital, Capital Medical University, a leading ophthalmic research institution in China.

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.

Unmet Needs in DED Management

Dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles. Restoration of tear film homeostasis is the ultimate goal in the management of DED, and this involves breaking the vicious circle of the disease. Determining whether the major cause(s) of an individual's DED pertains predominantly to aqueous tear deficiency or to evaporative causes, or both, is critical in helping select the most appropriate management strategy.

Management of DED is often complex. The challenge remains to develop management and treatment strategies that are not overly complicated for our patients. The heterogeneity of the DED patient population mandates that practitioners manage and treat patients based on individual profiles, characteristics and responses.

Current clinical approaches include physical interventions (e.g., punctal occlusion) and pharmacological therapies (e.g., 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. It 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.

About RTP-008

RTP-008, developed based on Raytone Biotech's iSus® bioabsorbable sustained-release drug delivery platform, is a novel ophthalmic therapeutic designed to address the complexities of dry eye disease. The iSus® platform utilizes advanced polymer-drug composite technology to achieve precisely controlled drug release for weeks to months following a single administration. The dual mechanism of action of RTP-008 addresses two key pathological aspects of dry eye:

(1) 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; 

(2) 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. In addition, the plug's physical presence extends drug retention time, creating a self-reinforcing therapeutic loop.

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. Raytone will also research and develop other ocular drug-device combination products in parallel, while extending its mature products into the field of pet healthcare."

About Raytone Biotech

Raytone Biotech, founded in 2021, is an innovative biotech company specializing 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's proprietary iSus® bioabsorbable sustained-release technology platform enables precise drug release that lasts from days to months following a single administration. The company's lead product, RTP-008, represents a breakthrough in moderate-to-severe dry eye disease (DED) treatment by integrating punctal occlusion functionality with sustained immunosuppressant delivery. A single administration can maintain therapeutic efficacy for several months, significantly improving patient compliance. Raytone is dedicated to driving the transformation of ophthalmic treatment towards a "long-lasting and precise" model, bringing benefits to people with eye diseases worldwide.

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SOURCE Raytone Biotech