A long-acting, constant release ocular implant for the sustained delivery of biologics and small molecules for the treatment of retinal diseases.

Project Information

BlueDot

Grant agreement ID: 882295

DOI

10.3030/882295

Project closed

EC signature date 9 December 2019

Start date 1 November 2019

End date 29 February 2020

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

MICROSERT LTD
Israel

Periodic Reporting for period 1 - BlueDot (A long-acting, constant release ocular implant for the sustained delivery of biologics and small molecules for the treatment of retinal diseases.)

Reporting period: 2019-11-01 to 2020-02-29

Summary of the context and overall objectives of the project

Retinal diseases are the leading cause of blindness and visual impairment in people aged 50 years and older in Europe. Retinal diseases such as Age-related Macular Degeneration (AMD), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Glaucoma, etc. pose a significant economic burden on the patients, their families, society and the healthcare systems. The prevalence of retinal diseases such as wet AMD and DME is increasing. In 2014, 170M people around the world suffered from AMD and this number is expected to rise to 196M by 2020 and to 288M by 2040. Europe is expected to have the second highest number of AMD cases, trailing just behind Asia. The complexity of eye anatomy presents several challenges for effective treatment of these diseases. Microsert propose the BlueDOT system which uses a long-acting release (LAR) ocular implant for the sustained delivery of wide range of drugs (e.g. biologics and small molecules) for the efficient treatment of retinal diseases. The BlueDOT implant is delivered empty, sterile and within the insertion needle of the special insertion device. Inserting, re-filling and removing of the BlueDOT implant from the patient's eye does not require incision and can be performed as an ambulatory procedure in the physician’s OPD

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

During the feasibility assessment, Microsert has completed a full analysis of the technical and business potential of the BlueDOT. Throughout the project, Microsert has greatly expanded their knowledge regarding the technical objectives, potential target markets, and regulatory approval required for European market launch.
The key technical milestones achieved during the feasibility period was the securing of Qsite, fo regulatory approvals to be undertaken during the next phase of development. Microsert also decided on the parameters that they need to improve in the BlueDOT implant and the insertion device prior to licensing the it to the pharmaceutical company. The company also analyzed their production capabilities in conjunction with their future targets and decided it was advantageous to set-up a clean room to produce the implants and the insertion devices for the next phase of development and validation.
Microsert analyzed in detail the go-to-market strategy to define the approach for accelerated and effective market uptake. It was concluded that initially, the BlueDOT will be targeted at ocular drug delivery market due to a huge unmet need, high CAGR and the increasing number of elderly worldwide. The company expects to achieve revenues of €119M in year 5 and to reach a total of 42 total employees five years after commercialization. The company also secured the interest of three major pharmaceutical companies for commercialization of their innovative technology.

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 expected outcome of the project is to successfully execute the pre-clinical validation and demonstrate that the efficacy of Microsert’s drug delivery system. The BlueDOT implant releases the drug slowly in the eye over a pre-determined period, thus, ensuring a constant and even dosage for the eye condition. This improves the quality of life of the patients, allowing them to live more independently. For Healthcare systems, the BlueDOT implant represents an opportunity to reduce the unnecessary costs associated with existing treatments and generate new revenue streams. Ophthalmologists would also benefit from the BlueDOT implant as they will need to undertake lower number of complicated and lengthy invasive procedures. The use of BlueDOT implant thus will generate both economic and social benefits.