Recent research published in Ophthalmology evaluated the use of mydriatic eye drops administered via the Optejet user-filled device (UFD) versus standard eye drops.
The intent: To determine the drops’ non-inferiority on pupillary dilation among pediatric patients.
Let’s start with this delivery system.
Developed by Eyenovia, Inc.—which, if you’ll recall, rebranded to Hyperion Defi, Inc. earlier this year— the Optejet UFD is an FDA-cleared proprietary dispensing platform designed with a sterile-filled, replaceable drug cartridge to dispense topical eye medications for ocular therapeutics.
How it does this: By utilizing a unique Microdose Array Print (MAP) technology as the delivery system (operating in a manner similar to that of an ink jet print)
- See a visual of this in action.
And you mentioned it’s already received U.S. regulatory clearance?
Indeed, it has. The system is currently only cleared to operate as the delivery dispenser for another FDA-cleared product from Hyperion DeFi:
- Mydcombi (tropicamide and phenylephrine hydrochloride [HCl] ophthalmic spray) 1%/2.5%, indicated for inducing mydriasis.
Wasn’t it under investigation for use in another ophthalmic condition as well?
Emphasis on was. More specifically: Optejet was previously part of a phase 3 evaluation for pediatric progressive myopia, in which it was used as a drug-device combination with low-dose atropine.
- However, the company reported last November that the study (dubbed CHAPERONE) failed to meet its primary goal.
Gotcha. Now, what should we know about this new research?
To start: Investigators sought to address a few all-too-common limitations associated with the traditional form of sequential, manual eye drop administration for pupil dilation.
- How: By switching to a less invasive, microdosing mechanism offered by the Optejet system.
Next: Give me a rundown on the study.
This randomized, interventional phase 4 clinical trial (NCT06366217) evaluated 67 pediatric patients (aged 2+; mean age: 8.8 years; 60% male) receiving a pupil dilation in both eyes as part of a standard, comprehensive eye exam.
The setup: Patients were randomized 1:1 and dilated just once using two different methods:
- Optejet + MydCombi (tropicamide 1% and phenylephrine HCl 2.5%) ophthalmic spray in one eye, followed by a second spray 5 minutes later
- Standard eye drop of tropicamide 1% and phenylephrine 2.5% administered via manual, topical application onto the second eye
And what was measured?
Measured before dilation as well as 30 minutes after dilation, the primary outcomes included a percentage change in:
- Maximum pupil diameter
- Pupil constriction percentage
Among the secondary outcomes: Percentage change in intraocular pressure (IOP) and cycloplegia (defined as the change in spherical equivalence [SE] before and 30 minutes after dilation).
Anything to note about these outcomes?
Both changes in maximum pupil diameter and pupillary constriction were “prespecified and required to reach statistical significance to demonstrate non-inferiority,” according to investigators.
Additionally: ≤ 6.0 mm was defined as a “clinically significant poor pupillary dilation.”
Now to the results.
We’ll begin with the maximum pupil diameter for each group:
- Eye drop: 7.65 mm (95% confidence interval [CI] 7.45 to 7.85 mm)
- Ophthalmic spray: 7.72 mm (7.54 to 7.90 mm)
And the change in maximum pupil diameter:
- Eye drop: 2.15 mm (1.96 to 2.35 mm)
- Ophthalmic spray: 2.48 mm (2.09 to 2.87 mm)
Talk about the changes in pupillary constriction.
For the eye drop group, this was -30.29% (-33.03 to -27.55%), compared to the ophthalmic spray group’s -32.29% (-34.87 to -29.70%).
So was non-inferiority achieved for secondary outcomes?
Unfortunately, no. However, the investigators’ observed differences for both the change in SE as well as IOP were “small and unlikely to be clinically meaningful.”
And any limitations to be aware of?
A few were highlighted, including the investigators' selection of a non-inferiority margin of 10% (which they noted was “more conservative” than the 50% margin typically recommended by the FDA).
See here for their reasoning behind this—as well as two other limitations.
Now to the general takeaways.
The investigators stated that, compared to eye drops, the ophthalmic spray met non-inferiority criteria for both maximum pupil diameter and pupillary constriction percentage.
- As for the patients themselves: A reported 67% of participants preferred the spray over the drops.
Based on this, what did the study authors conclude?
Essentially, the ophthalmic spray of medication (delivered via the Optejet) was “non-inferior to traditional eye drops" for both maximum pupil diameter and pupillary constriction percentage.
- “Ophthalmic sprays have the potential to increase the acceptability of pupillary dilation in children while maintaining a similar mydriatic effect as eye drops,” they wrote.
But for the future: They recommended that additional investigation is needed to "characterize the cycloplegic properties” of the ophthalmic spray’s route of administration.