A BREAKTHROUGH TECHNOLOGY DESIGNED TO PRESERVE SIGHT AND HALTING VISION LOSS ASSOCIATED WITH A RANGE OF RETINAL DISEASE BY PREVENTING THE DEATH OF KEY RETINAL CELLS .

Project Information

SeaBeEYE

Grant agreement ID: 101113845

DOI

10.3030/101113845

Project closed

EC signature date 28 June 2023

Start date 1 July 2023

End date 30 June 2024

Funded under

• European innovation ecosystems

Total cost

No data

EU contribution

€ 75 000,00

Coordinated by

SEABELIFE SAS
France

Periodic Reporting for period 1 - SeaBeEYE (A BREAKTHROUGH TECHNOLOGY DESIGNED TO PRESERVE SIGHT AND HALTING VISION LOSS ASSOCIATED WITH A RANGE OF RETINAL DISEASE BY PREVENTING THE DEATH OF KEY RETINAL CELLS .)

Reporting period: 2023-07-01 to 2024-06-30

Summary of the context and overall objectives of the project

Context and Overall Objectives
The SeaBeEYE project, led by SeaBeLife, aimed to tackle significant unmet medical needs in the realm of retinal diseases, which can lead to severe vision loss and currently lack effective treatments. SeaBeLife, a French biotechnology company, has been at the forefront of developing first-in-class drug candidates to protect and regenerate organs impacted by serious pathologies. With the support of the Women TechEU grant, SeaBeLife embarked on an innovative journey to create advanced treatments for retinal diseases, focusing specifically on achieving proof-of-concept (POC) for novel vision protection technologies.

Activities and Achievements
The primary objective of the SeaBeEYE project was to develop and validate formulations designed for intravitreal (IVT) and ophthalmic gel applications. The project commenced with the development of two clinically relevant formulations:

(1)-Sustained Release Formulation for Intravitreal Administration: This formulation aimed to release the therapeutic agent over an extended period, enhancing treatment efficacy and patient compliance.
(2)-Ophthalmic Gel for Instillation: This innovative approach intended to provide a non-invasive route of administration, making treatment more accessible and patient-friendly.

Key partnerships played a crucial role in the project's success. A specialized Contract Research Organization (CRO) in France, was engaged to develop and produce prototypes for both formulations. They also conducted comprehensive in vitro characterizations and preliminary stability studies. Another key partner conducted in vivo pharmacokinetic evaluations using a rabbit model, demonstrating effective retinal delivery of the ophthalmic gel formulation.

Expected Impact:
The SeaBeEYE project is poised to make a significant impact in the field of ophthalmology by introducing new treatment paradigms for retinal diseases. The sustained release IVT formulation and the ophthalmic gel for instillation offer distinct advantages over current solutions, including prolonged drug release and non-invasive administration. These advancements are expected to improve patient outcomes, reduce the frequency of treatments, and enhance the overall quality of life for individuals suffering from retinal conditions.

Role of Social Sciences and Humanities:
While the primary focus of the SeaBeEYE project is scientific and technological, the integration of social sciences and humanities is implicit in its approach to patient care. By prioritizing non-invasive treatment methods and aiming to enhance patient compliance and accessibility, the project underscores the importance of patient-centric solutions in medical innovation.

Conclusion
The Women TechEU grant has been instrumental in propelling the SeaBeEYE project forward, enabling SeaBeLife to make significant strides in developing breakthrough treatments for retinal diseases. With continued efforts and further validation, these innovative formulations have the potential to transform the landscape of vision care and offer new hope to patients worldwide.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Activities Performed
Formulation Development: SeaBeLife collaborated witha CRO to develop two clinically relevant formulations: a sustained release formulation for intravitreal (IVT) administration and an ophthalmic gel for instillation.
In Vitro Evaluations: Studies showed that the IVT formulation could release the active ingredient SBL03 over a period of 2 to 6 months.
In Vivo Evaluations: Our partner demonstrated that the ophthalmic gel effectively diffused to the retina in a rabbit model.

Project Management: Coordinated by Morgane Rousselot and Lucie Churet, ensuring effective project management and successful collaboration with partners.

Main Achievements
Successful Formulation Development: Creation of two innovative formulations validated by in vitro and in vivo studies.
In Vitro Success: Confirmed prolonged release of SBL03 for the IVT formulation.
Positive In Vivo Results: Effective retinal diffusion of SBL03 with the ophthalmic gel.
Risk Mitigation: Successfully managed initial risks, ensuring project progression.
These achievements lay the groundwork for future clinical treatments of retinal diseases, potentially transforming eye care and improving patient outcomes.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The SeaBeEYE project developed two groundbreaking formulations for retinal diseases: a sustained release intravitreal (IVT) formulation and an ophthalmic gel for instillation. These innovations offer prolonged drug release and non-invasive administration, surpassing current treatments. Key needs for further success include additional clinical trials, securing funding, robust commercialisation strategies, intellectual property protection, regulatory support, and international partnerships to ensure market adoption and patient benefit.