Eyenovia, Inc. and SGN Nanopharma Inc. are collaborating to develop and validate a novel drug-device combination featuring the companies’ Optejet dispenser and proprietary platform-based cyclosporine formulation to treat chronic dry eye disease DED).
Wait just a minute here… this all sounds eerily familiar.
That’s not surprising, given Eyenovia quite literally just announced a similar partnership with Senju Pharmaceutical Co. Ltd.
- The similarities: That collab also features the company’s Optejet dispenser and will be used to develop a chronic DED eye drop device-combo.
- The difference: The Eyenovia-Senju partnership involves Senju’s topical ophthalmic formulation (SJP-0035) for corneal epithelial wound healing
Now let’s get a refresher on these players.
First up: Eyenovia.
The U.S.-based, late-stage ophthalmic biopharmaceutical company is developing a pipeline of micro-dosed treatments for anterior and posterior segment disease sequelae and diagnostic ophthalmic evaluations (i.e., DED, myopia, and mydriasis).
Regulatory note: In May 2023, the FDA approved MYDCOMBI (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1% / 2.5% for inducing mydriasis.
And its proprietary technology?
Dubbed the Optejet device platform, this technology is key to Eyenovia’s therapeutics—and is also FDA-cleared as the delivery system for MYDCOMBI.
Give me the details.
The Optejet device is designed to dispense topical eye medications for ophthalmic therapeutics.
How it works: The device uses Eyenovia’s Microdose Array Print (MAP) technology as a topical delivery system—akin to an inkjet printer—to dispense medication in a horizontal mist, coating the surface of the cornea.
- Note: Optejet makes contact with the eye at a low velocity so as to reduce ocular surface impact.
For chronic medications: The device is intended to ensure patient adherence while providing real-time data to an eyecare professional (ECP).
And how is this form of topical delivery unique?
As we previously noted, this option for administering precise dosings not only reduces the potential for drug overflow/overdosing, but can also be done with a reported 80% less exposure to both the drug and preservative toxicity.
See the supporting clinical data on Optejet’s delivery mechanism.
Gotcha. So tell me about SGN Nanopharma.
The Tampa, Florida-based, clinical-stage nanopharmaceutical company is developing best-in-class fixed-dose combination nanomedicines.
Key to this: A proprietary nanotechnology platform that serves as the basis for a pipeline of therapeutics targeting the following diseases and conditions:
- DED
- Acute post-op pain relief
- Moderate-to-severe preoperative knee pain
- Diabetic neuropathy
- Erectile dysfunction
- Rheumatoid arthritis (RA)
Now this platform.
SGN’s Micellar Nanoparticle (MNP) Platform is designed to serve multiple applications, including routes via ocular/nasal, oral, topical/transdermal, parenteral, and vaginal/rectal.
The platform delivers on four key components:
- Multiphasic
- Enables active pharmaceutical ingredients (API)—which offer a slow release in the oil phase as well as reduced irritability—distribution in the following phases:
- Free micro-/nanoparticle-based drugs
- Oil droplet-associated drug
- Micelle-associated drug
- Drug in solution within hydro-alcoholic droplet
- Enables active pharmaceutical ingredients (API)—which offer a slow release in the oil phase as well as reduced irritability—distribution in the following phases:
- Engineerable
- Controlled API proportion in various phases, particle sizes (10 nm to 100 nm), and ingredients plus develop complex formulations
- Multiple APIs
- Broad spectrum of formulated APIs via MNP technology
- Includes APIs with various physicochemical properties with stable/scalable formulations
- Broad spectrum of formulated APIs via MNP technology
- Scalable and stable
- Scalable with stability already demonstrated for 25+ different APIs (standalone and combination formulations included)
And how was it used for SGN’s dry eye therapeutic?
The MNP platform was utilized to develop the company’s 0.05% MNP cyclosporine ophthalmic emulsion (SGN-101), a novel topical formulation of cyclosporine A (CsA).
Its purpose: To provide better penetration into ocular target tissues—compared to standard CsA delivered via oil-based topical formulations, which have been found to have limited penetrance— as well as less ocular surface irritation.
How: By delivering the active ingredient to the ocular surface in neutral to positively-charged nanoparticles (150 to 170 nm) in two phases: aqueous and oil globules.
The intent: For CsA unique properties to enable the formulation to possibly have better access to the deep layers of the cornea and other ocular surface areas—essnetially improving efficacy with minimal to no adverse effects.
Has its efficacy been demonstrated?
It has! In fact, data from a head-to-head, randomized control trial (RCT) evaluating its efficacy among 155 keratoconjunctivitis sicca (KCS; dry eye) subjects demonstrated SGN-101’s superiority over AbbVie’s RESTASIS (cyclosporine ophthalmic emulsion) 0.05%.
- Note: SGN-101 was evaluated in two doses, administered either twice daily for the entire 12-week study duration or twice daily for the first 4 weeks and then once daily for the remaining 8 weeks.
- RESTASIS was administered twice daily for the entire study period.
The study results were published in BMC Ophthalmology, where, beginning at Week 4 of treatment, SGN-101 (evaluated in two doses) was found to be statistically superior to RESTASIS and well-tolerated.
And the significance of this data?
Eyenovia CEO Michael Rowe noted the “significant shortcomings” of currently-available formulations for DED (excluding CsA), including “a delayed onset of action of up to 12 weeks and unpleasant side effects that result in significant patient attrition and noncompliance,” he stated.
Now to this partnership… how is the Optejet being integrated?
Per the agreement, the companies will develop SGN-101 to be used with the Optejet dispenser.
“With the precision dosing afforded by the Optejet dispenser, we believe we can further improve this promising drug's efficacy and tolerability profile,” stated Navdeep Jaikaria, PhD, SGN’s chairman and CEO.
Rowe added that this duo combination, “will result in a more efficacious and better tolerated cyclosporine-based treatment that we believe has the potential to become the standard of care in this multi-billion-dollar addressable market.”
A multi-billion-dollar market, you say?
Yup… the U.S dry eye market alone is estimated to be reach over $6 billion this year—and of that, the cyclosporine-based therapeutic market is reported to rake in approximately $2.35 billion.
Wow… so what’s next for this partnership?
The new collaborators are reported to be validating this drug-device combo product’s manufacturability in order to support clinical testing.
Following this, they plan to schedule a consultation meeting with the FDA to talk about next steps for clinical development.