Safety Syringes

Advancing Retinal Drug Delivery Through Innovative Injection Technology

Partner
Spin-off in 2016, collaborating with Sheba Medical Center and Rad-biomed incubator.
Device
Novel delivery technology for suprachoroidal administration.
Delivery Profile
Delivery of therapeutics to the choroid and retina (to the back of the eye) via the suprachoroidal space (SCS) with rapid and extensive distribution to the posterior segment of the eye and the macula.
Key Challenges
01
Adapting the original methods to a device that will be easily used and will consistently allow injections to be made into the SCS, a very thin layer covering the retina, without injecting to the vitreous or injecting too shallow.

Solution

Proprietary, sharp needle tip penetration with a stopper, and geometrically-optimized non-sharp tissue separator that opens path into SCS, enabling a tangential injection that leads to rapid and extensive distribution.

Background

Everads Therapy was founded as a spin-off startup company. The company was established within RAD Biomed, a premier biotech accelerator, and is built on core technologies licensed from the laboratory of Prof. Yigal Rotenstreich at Sheba Medical Center.

DALIMED was chosen to join as a recognized leader in injectable drug delivery technologies.

The Challenge | Addressing a Critical Unmet Need

Retinal diseases such as Age related Macular Degeneration (AMD) require repeated intravitreal injections, which can be burdensome for patients and carry risks of side effects and complications.

The medical community continues to seek solutions that improve drug delivery efficiency while reducing treatment frequency and patient discomfort.

The Innovation

The journey began when Sheba Medical Center approached DALIMED with a groundbreaking invention developed by Prof. Yigal Rotenstreich. The concept introduced a novel approach for delivering drugs to the back of the eye, targeting retinal diseases more effectively.

This innovative method was designed to:

  • Enable superior distribution of therapeutic agents across the retina
  • Target the posterior segment of the eye with higher precision
  • Reduce the need for frequent intravitreal injections
  • Minimize associated side effects and risks

Development Process

Developing its first Opthalmic injector, DALIMED focused on simplifying the injection procedure while maintaining high performance and safety standards.

The development phase included:

  • Extensive preclinical testing across multiple models
  • Iterative design improvements to optimize delivery efficiency
  • Engineering refinements to enhance usability for clinicians

Throughout this process, several new patents were successfully filed, strengthening the intellectual property portfolio and reinforcing the uniqueness of the solution.

Clinical Progress

The product has successfully completed a Phase 1 clinical trial in humans, demonstrating a favorable safety profile and initial efficacy signals. Building on this success, the device is currently being evaluated in a Phase 2 clinical trial in combination with a therapeutic compound provided by one of Everads’ partners.

Starting the clinical trials was based on approved Investigational New Drug (IND) application after submitting a Master Access File (MAF) to the FDA.

Impact and Future Outlook

This innovative drug delivery product has the potential to transform the treatment paradigm for retinal diseases by:

  • Reducing treatment burden on patients
  • Improving clinical outcomes through better drug distribution
  • Enhancing safety and patient compliance

As clinical development progresses, Everads continues to collaborate with pharmaceutical partners to expand the application of its technology across multiple ophthalmic indications, aiming to set a new standard in retinal drug delivery.

Outcome

First In-Human study completed successfully, after the technology has been validated in over 60 non-human-primates using various modalities including AAV vectors, anti-VEGF antibodies, nanoparticles, and other materials.
A Master File has bee submitted to the FDA, supporting Everad’s pharma client in IND submission. A Phase I/II clinical study is in progress.

Contact Us

Talk to us about your drug delivery device needs

    DALIMED has been developing drug delivery devices from concept to commercialization since 2003, serving pharmaceutical and medical device companies.

    Our injectable solutions are designed to improve patient compliance with biologic, biosimilar, and generic therapies, offering greater ease, comfort, and enabling simple self-administration. With expertise across the full product lifecycle, 
we provide both market-ready devices and customizable solutions tailored to specific needs-covering everything from design and development to verification, validation, and compliance with all relevant standards and regulations.

    Tel: +972-8-3730080
    Email: info@dalimed.com