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An innovative, effective and minimally-invasive retinal cell therapy combined with a new injection system for treatment of retinal degenerative diseases.

Periodic Reporting for period 1 - EIS (An innovative, effective and minimally-invasive retinal cell therapy combined with a new injection system for treatment of retinal degenerative diseases.)

Berichtszeitraum: 2019-11-01 bis 2020-02-29

Retinal degeneration is a leading cause of incurable low vision and blindness affecting about 200 million worldwide. The pathologies include inherited retinitis pigmentosa (RP), age-related macular degeneration (AMD), diabetic retinopathy (DR), diabetic macular edema (DME) and other damages to the eye/retina. Despite recent therapeutic advances for retinal diseases the real-world results of treatment are poor, and there are no or only limited treatment options in many areas, resulting in an overall high unmet need. One of the major challenges of such treatments is inability to deliver the therapy to the right place with the right dosage. This lead to ineffective treatment and results into multiple re-visits to the doctor for repeat treatment and poise side effects like IOP and glaucoma resulting in worsening the condition.
EIS is a novel delivery system for delivery of advanced retinal therapies into the back of the eye. The device encompasses a minimally-invasive injector and a fixation tool, featuring a unique access method through the suprachoroidal space and the matrix between the choroidal blood vessels. It is an effective retinal delivery method with wide drug distribution over 80% which leads to minimal surgeries needed for treatment.
Identifying the need, Everads developed the safe, minimally invasive and effective device to deliver targeted therapy, potentially improving the clinical outcome. The EIS delivery system has minimal side effects and will drastically improve patient's quality of life. It allows the patients who often tend to be elderly be more independent. Everads Therapy thus envisions a future where safer and effective therapy delivery techniques will enable better outcomes for retinal degeneration treatment.
The overall objectives of the project include, defining a minimum viable product, establish a feasible product development plan and industrialisation strategy, plan demonstration and validation trials and analyse risks and opportunities.
Everads reviewed in more detail the current stage of EIS and defined a sound development plan based on the remaining activities needed for a product ready to be used for integration with advanced retinal therapies. This will lead to a successful partnership with pharmaceutical companies for product integration, clinical trials of combined therapy (Phase I and II trials) and ultimate commercialization. Everads aims to review, engineer and optimise the components of EIS. This includes reviewing the specifications of EIS, optimization of several components, design freeze and development of EIS prototypes. Then the aim is to optimize different manufacturing process, validate supply chain, prepare and finalise production and quality protocols, establish in-house production line and assembly for EIS and manufacturing first batch of EIS to be used for pre-clinical validation studies. Everads will conceive the plan and conduct pre-clinical validation studies to confirm safety and efficacy of updated EIS as a delivery system for injectable retinal therapies. This will enable to submit a technical file for CE marking, preparation of FDA Masterfile and to be ready for use in clinical studies with the partner pharmaceutical company. Everads analysed in detail the go-to-market strategy to define the approach for accelerated and effective market uptake. It was concluded that sales through licensing out the EIS units to partnered pharmaceutical company which will further conduct clinical studies and hence reach to hospitals and ophthalmology centers is the preferred go to market strategy. This will allow easy penetration of multiple and diverse markets as big pharmaceutical have multiple ongoing contacts with various hospitals. Everads recently signed an option agreement with a pharma company to exploit the EIS product. This pharma company will evaluate Everads' suprachoroidal delivery system with a number of its pipeline products according to a mutually-agreed-upon pre-clinical research plan. In this scenario, the EIC project will be crucial to finalize EIS and finally conclude the agreement with the pharma company.
The expected outcome of the project is to successfully upgrade EIS with design development and increased efficacy results after the pre-clinical validation studies. The results will be used to apply for the CE Mark (Medical device) certification to be technically ready for the partnered pharmaceutical company to conduct clinical trials in combination to their retinal therapies. EIS will improve the quality of clinical treatments by ensuring high-performance and safe therapeutic delivery solution, resulting in cost savings by 37%, improved quality of life for people affected by retinal degenerative conditions by 68%, thereby helping relieve a major societal burden.
The total costs of managing the consequences of severe/late-stage AMD alone in the EU was estimated to be €89.46 billion per year among adults aged 50 years and older. With the use of the EIS combined delivery, these costs can be reduced or even completely eliminated due to multiple advantages generated by Everads novel delivery system. Directly EIS commercialization will create 32 high skilled jobs in Europe.