Eyenovia Inc

Invention:	Eye drop dispenser
Trademark:	Optejet™
Patents:	16
NASDAQ:	EYEN

The invention

Optejet is a digital device designed to address issues with ease-of-use and dosing precision in ophthalmic drug delivery. It utilizes microdose array print technology to deliver drugs effectively, improving tolerability and reducing side effects. Optejet aims to improve the usability of topical ophthalmic medications.
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The device includes:

• A replaceable drug cartridge system that is proprietary and pre-filled, ensuring sterile drug delivery.
• A spray nozzle with 109 laser-drilled ports for precise drug delivery, avoiding the need for eye dropper bottles that can lead to contamination and wastage.
• An ergonomic design with horizontal delivery, push-button dosing, and no protruding tip, making it easier and more comfortable for patients to use.

Performance advantage

​The Optejet presents several advancements over standard eyedropper bottles for ophthalmic drug delivery, making it a significant improvement for patients requiring eye medications. Here are the key benefits and improvements Optejet offers compared to traditional eye drops:

1. Improved Usability and Comfort:

• Ergonomic Design: Optejet's design allows for horizontal delivery with a push-button dosing mechanism, eliminating the need for patients to tilt their heads back and squeeze a bottle, which can be challenging for many users.
• No Protruding Tip: Unlike eye dropper bottles whose tips can touch the patient's eye surface, potentially causing discomfort or contamination, Optejet has a recessed nozzle protected by a shutter when not in use.

2. Precision Dosing:

• Microdose Technology: Optejet delivers 80% less drug volume than traditional eye droppers, reducing excessive drug and preservative exposure to ocular tissues. This minimizes the risk of local side effects and systemic absorption.
• Spray Nozzle with 109 Laser-Drilled Ports: Ensures a precise and consistent dose with each use, which is critical for the effectiveness of many ophthalmic drugs.

3. Sterile Drug Delivery:

• Replaceable Drug Cartridge System: Designed for sterile drug delivery, the proprietary pre-filled cartridges are thoroughly tested to demonstrate microbial integrity, ensuring that the medication remains uncontaminated throughout its use.

4. Digital Health Integration (Optecare™):

• Automatic Usage Tracking: The ability to automatically track medication usage and integrate with digital health platforms offers patients reminders and progress tracking, which can significantly improve adherence to treatment regimes.
• Physician and Payer Benefits: Provides real-time data for healthcare providers to monitor patient compliance and outcomes, potentially reducing the need for additional medications and saving costs through improved disease management.

5. Reduced Waste and Overdose Risk:

• Minimized Drug Waste: By delivering a microdose, Optejet ensures that the drug is utilized more efficiently, reducing waste associated with the overflow common in standard eyedrop use.
• Lower Risk of Overdosing: Precision dosing also reduces the risk of applying more medication than needed, which can be a risk with traditional eyedrops due to their less controlled delivery method.

6. Enhanced Safety and Tolerability:

• Minimizes Side Effects: The reduced volume of medication not only decreases the potential for systemic side effects but also improves local tolerability by limiting the exposure of ocular tissues to potentially irritating substances.

Addressable market

​The addressable market for Optejet encompasses several large-market opportunities, each with significant revenue potential in the United States:

1. Office-Based and Surgical Pupil Dilation Market: Valued at approximately $250 million in the United States. This market includes around 108 million office-based dilations annually, with current pupil dilation methods having numerous shortfalls, such as the need for multiple eye drops, patient discomfort, time-consuming administration, and cross-contamination risks. Optejet aims to address these issues, offering a more efficient and patient-friendly solution​​.
2. Pediatric Progressive Myopia Market: Estimated at $1.8 billion in the US and similarly in China. Progressive myopia is a global issue affecting millions of children, leading to significant vision problems if not controlled. Optejet's ease of use, lower systemic exposure, and connected-care features (Optecare service) position it as a promising solution for managing this condition​​.
3. Presbyopia Market: Estimated at $850 million. Optejet's features, including ease of use and low side effect incidence, make it a suitable candidate for addressing presbyopia, a condition associated with aging that affects the ability to focus on close objects​​.
4. Additional Large-Market Opportunities: Include glaucoma and dry eye, with the addressable market for glaucoma estimated at $2.7 billion and acute dry eye at $610 million in the United States. Chronic dry eye, another significant opportunity, is part of a larger dry eye market valued at $5.5 billion. Optejet's advantages, such as ease of use, fast onset, and low side effect incidence, could make it a competitive option in these markets as well

Intellectual property

​The company has 16 patents issued in the US. 

Regulatory status

Eyenovia has been actively pursuing FDA approval for specific drug formulations delivered via the Optejet device for various ophthalmic conditions:

1. Mydcombi™ for Pupil Dilation: Eyenovia announced FDA approval for Mydcombi, a microdose formulation of tropicamide and phenylephrine for mydriasis (pupil dilation), delivered using the Optejet device. This approval marks a significant milestone as it is the first FDA-approved product using the Optejet technology, validating its potential for other applications.
2. MicroPine for Progressive Myopia: Eyenovia has been developing MicroPine, a microdose formulation of atropine for the treatment of progressive myopia in children, to be delivered using the Optejet device. The company has been conducting clinical trials and working towards FDA approval for this indication.
3. MicroLine for Presbyopia: Another product in development is MicroLine, a microdose formulation of pilocarpine for the treatment of presbyopia, also intended for delivery via Optejet. Eyenovia has been advancing clinical trials for MicroLine and seeking FDA approval.

Upside

As at 17 Feb 2024, the company's market cap (USD$75m) is low relative to the size of its addressable markets.


Sources

Eyenovia corporate presentation, January 2024
https://ir.eyenovia.com/static-files/e0c3463a-52b4-4c8d-a20c-d66e3942f283