Eye-D – In-office insertable platform for a long term controlled release of ophthalmic medications
ViSci develops controlled released drug delivery technology – The Eye-D VS-101
Eye-D, an in-office insertable platform that provides for controlled release of ophthalmic medications over time, thereby resolving poor compliance with eye drop treatment regimens and permitting 100% patient compliance with drug therapy regimens. Our first product candidate utilizing the Eye-D platform, the VS-101, contains the most prescribed glaucoma medication worldwide, latanoprost. We believe that the Eye-D platform can be further developed to treat various other ocular conditions. The VS-101 concluded a Phase 1/2a clinical study in the United States as part of a new drug application under the Food and Drug Administration, or FDA, 505(b)(2) regulatory pathway.
Clinical Results Demonstrate Safety & Efficacy. Phase 1/2a protocol: Randomized, blinded, controlled, Compared three different insert elution rates (high, medium & low) with latanoprost eye drops (control group), 39 subjects, 3 months duration.
- Proof of concept in humans achieved
- Safety endpoint achieved (no unanticipated findings, no severe adverse events)
- Evidence for efficacious/preferred dose (high dose)
- Supporting information for improving retention in phase 2b
The treatment of glaucoma comprises one of the largest segments in the ophthalmic market. According to a Market Scope study, there are approximately 78 million glaucoma patients worldwide, 10 million of whom are located in the United States. The rate of diagnosis and treatment of glaucoma and ocular hypertension is increasing, particularly in emerging economies where healthcare infrastructure and access to diagnostic and treatment technologies are improving.
According to GlobalData, improving patient compliance with glaucoma medication therapy represents the most significant unmet medical need within the glaucoma care field. Market Scope expects the global glaucoma pharmaceutical market to climb from roughly $4.7 billion in revenues in 2015 to nearly $6.1 billion in 2020, at a compounded annual rate of 5.1%.
Known poor compliance and adherence with eye drops is a major clinical challenge with no meaningful solutions. Poor compliance occurs in an estimated 25 to 70% of patients, especially when those drugs need to be administered more than once daily.
A safe, tolerable and simple insert delivering a drug for up to 12 months, thus offering 100% compliance, would address this widely recognized unmet need.
The current technology is targeted to compete in the $4-5 billion glaucoma market worldwide.
A simple in-office procedure, in which a doctor places the VS-101 latanoprost subconjunctival insert through a small opening created in the conjunctiva, enables the VS-101 to release latanoprost in a controlled manner over time, ensuring 100% patient compliance to drug therapy.
The insert is a safe, well tolerated and placed with a simple, quick procedure. It avoids the need for daily administration of eye drops. It would offer a reliable and convenient solution for many glaucoma patients struggling with their current eye drop therapies that can involve taking two to three different medications several times per day.
The insert is placed under the eyelid, just below the surface of the eye in a quick, safe office procedure (5-10 min.) by an ophthalmologist and will be invisible to the patient. It allows use with a wide variety of future drugs in multiple indications. Some other areas of use for this technology include: bladder, prostate and skin.