Micro Ocular Drug Delivery System



This project develops an easily implantable, refillable, reservoir-type device for long-lasting ocular drug release. The device is capable of sustained and controlled release of biologic medications and can be refilled for up to two years after being implanted. It intends to further develop this versatile drug-delivery platform for the treatment of age-related macular degeneration (AMD) and diabetic macular edema (DME), while its implant can also be used for punctal implant(dry-eye condition) and and in-vitro fertilization (IVF) implant.

According to statistics, there are about 285 million people with visual impairment in the world, of which 246 million suffer from low vision (severe or moderate visual impairment); DME is the main cause of blindness in working-age population in developed countries; AMD is the third leading cause of decreased vision and the number one untreated disease in developed countries. In China, more than 100 million people have diabetes. DME is the main cause of blindness in diabetic patients, with an incidence of 7.6% in diabetics. By the end of 2015, China's DME patients have exceeded 5.4 million; It is expected that China's DME patients will exceed 7.5 million by 2040.



Technology Introduction

Anti-VEGF therapy has been standard of care for over 10 years in the treatment of ocular neovascular disorders including: Neovascular (wet) AMD, DME, and more. However, current anti-VEGF intravitreal injection therapy is associated with burden on both the patient and the health care system: Patients need office visits every month for treatment and monitoring; Average of 6.6-to-8 intravitreal injections required in the first year depending on indication. The repeated and invasive injections are significantly increases the risk of complications. Furthermore, this method of drug delivery is of short duration because dynamic clearance mechanisms will rapidly eliminate current VEGF formulations from the vitreous.

This project provides a simple, low cost versatile implant, which is compatible with all drugs (tested w-small molecules and biologics), for treatment of chronic eye diseases.The implant can be refilled for up to two years from implantation, each refill is capable of releasing sustaining therapeutic drug concentration over 4-6 months. Thus reducing monitoring office visits from every 6 weeks to every 3-6 months. What’s more, this implant has no incision, which is a office-based procedure. The implant is made of medical grade elastomeric polymers. The implant is inserted into the eye in an empty compressed phase by using a fine needle, with no incision needed. By filling the implant with drug and removing the needle, the implant remains anchored beneath the conjunctiva and the drug is released in a controlled and sustained manner. Insertion of implant is performed using a unique insertion device, one-step, ambulatory procedure.



Intellectual property

The Company’s IP includes five (5) families of patents that cover the implant and the drug release concept by US patents # 8,821,474 and # 8,038,650 (both issued), and the delivery / insertion tools / system by US patent # 8,992,503 (issued). Addition applications worldwide are under.


Project Stage

This project has finished two in-vivo rabbits studies.

1st Study (preliminary) – completed successfully 

3 Subjects, One (1) month

Anchoring secured

No visible infections at histological examination  

Saline filled

2nd Study – completed successfully 

3 Subjects, Three (3) months

Insertion, Filling, Anchoring and Validation of end point sensor

No visible infections at histological examination  

Protein filled


Market Size

It is estimated that 76 million people will suffer from blindness by 2020. Age-related retinal disorders including AMD and DME are two of the leading causes of blindness in the world.

AMD is the leading cause of blindness in the United States and will affect nearly 8 million Americans by 2020 and cost the US healthcare system $30 billion per year. Nearly 300 million individuals have Diabetes worldwide and prevalence is rising. This project targets the retinal drug market. The global retinal disease drugs market is forecasted to reach $9.8B by 2018, with growth (CAGR) of 10% during the coming years.


Project Need

Strategic Partners

This project is looking for investors and strategic partners in the field of ophthalmic drug company, surgical staplers manufacturers etc.


Funding

The amount of funds invested in the Company as of today is $2M. The Company is seeking an investment of $3M to $5M* to allow completion of a First in Human trial (*depends on partner’s involvement in the trials.)