Eyenovia, Inc. is partnering with Senju Pharmaceutical Co., Ltd. to develop a potential new chronic dry eye disease (DED) treatment incorporating the companies’ proprietary technology and corneal epithelial wound healing candidate, respectively.
First up: these companies.
We’ll start with Senju.
Established in 1947 and headquartered in Osaka, Japan—with a U.S.-based subsidiary in Torrance, California since 2005—the privately-held, research-based pharmaceutical company is developing, manufacturing, and commercializing ophthalmic-based therapeutics.
Note: A reported +90% of its sales are generated from prescription-based drugs for indications such as:
- Eyestrain
- Itchy eyes
- Blepharitis
- Conjunctival hyperemia
And Eyenovia?
Founded in 2014 and headquartered in New York, New York, Eyenovia is a late-stage ophthalmic biopharmaceutical company developing a pipeline of micro-dosed treatments for both front- and back-of-eye diseases:
- Presbyopia
- Myopia
- Mydriasis
- Note: In May 2023, the FDA approved Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1% / 2.5% for inducing mydriasis.
Key to these therapeutics is Eyenovia’s proprietary technology: The Optejet device platform.
- Also: Optejet is FDA-cleared as the delivery system for Mydcombi
Refresh me on that technology.
The Optejet device is exclusively designed for ocular therapeutics as a way to dispense topical eye medications.
How it does this: By using Eyenovia’s Microdose Array Print (MAP) technology as a topical delivery system, which is similar to an inkjet printer.
- The process: Medication is dispensed horizontally in a mist, coating the surface of the cornea.
- Note: Contact to the eye occurs at a low velocity in order to reduce ocular impact.
And for chronic medications: The device is intended to ensure patient adherence while providing real-time data to a physician.
How exactly does this form of dispensation compare to standard eye drops?
It’s an alternative option for patients and clinicians both to administer in precise dosings.
As Eyenovia has noted, standard eye drops are typically 40μL in volume and exceed the absorption capacity of the eye (approximately 8μL).
The result of that: A potential for drug overflow when dispensed as well as an overdosing of excess drug and preservative.
Eyenovia’s solution: An 8μL medication dose is not only misted onto the cornea, but it’s done so with a reported 80% less exposure to both drug and preservative toxicity.
And the clinical data to support it?
A research study published in January 2023 evaluated the Optejet delivery system for dispensing latanoprost + benzalkonium chloride (BAK) treatment vs BAK administered via conventional eye drops to treat glaucoma.
The data reported favored the use of this dosing technology.
- Specifically: Optejet-administered drops were more effective in reducing inflammatory processes and pathways than with standard drops.
Alrighty, now bring in this Senju candidate.
Formulated as a topical ophthalmic solution, SJP-0035 is in clinical development for corneal epithelial wound healing.
- Its clinical data: The companies reported that, in two prior clinical trials (phase 1 and phase 2), SJP-0035 has been “well tolerated at multiple doses tested in over 250 subjects.”
Further, the eye drop is noted as having a unique mechanism of action that “has the potential to offer dry eye patients additional relief when compared to existing treatment options alone,” according to Mitsuyoshi Isaka, Senju corporate executive officer.
So what’s the intent behind this eye drop + device combo?
Quite simply: To use Eyenovia’s Optejet as a basis for administering SJP-0035 in patients with chronic dry eye.
By integrating these two products, the companies intend to develop a “more efficacious and highly-differentiated treatment” that has the potential to rapidly become a new standard of care for chronic dry eye, Isaka stated.
Will this be clinical studied?
Yes! A phase 2b trial is in the planning stages to evaluate SJP-0034 administered via the Optejet dispenser.
- Note: No further information is currently available on this study, but stay tuned!
Ahead of this, the companies expect to meet with the FDA in H2 2024 to present a clinical development proposal of the eye drop + device to support a potential new drug application (NDA) filing.
And the anticipated time frame for this?
Pending the outcomes of that FDA meeting, the phase 2b study could be completed by 2025.
If successful, a potential expansion to Eyenovia and Senju’s agreement may lead to two phase 3 studies by 2026.