Nanodropper, Inc. announced the release of promising data—published in Ophthalmology—from a non-inferiority clinical trial evaluating the company’s Nanodropper Adaptor vs conventional eye drops in delivering medication for the treatment of glaucoma.
Let’s start with this company.
Nanodropper, Inc. is a micro-volume ophthalmic delivery device company targeting solutions for adherence barriers in order to better manage chronic ocular disease.
Per the company, its products and educational content are designed to assist patients with issues such as vision insurance and eye care appointments, with the primary goal of reducing financial burdens.
Now this Nanodropper Adaptor.
As Nanodropper’s flagship product, the Adaptor is currently the first and only FDA-listed, volume-reducing sterile adapter for eye drop bottles that reduces the size of administered eye drops by coupling to the original bottle.
Its “one-size-fits-most” (an estimated 90% of multidose eye drop bottles) compatibility list can be found here.
Cost-wise: Per the Nanodropper website, it can be obtained directly from the manufacturer for $19.99, as well as at Amazon and DryEyeRescue.
Talk about this study.
The prospective, multicenter, randomized, parallel-group, single-masked, active-controlled, non-inferiority trial (NCT05181046) enrolled 424 participants (aged 18+) who were:
- Recently diagnosed with primary open-angle glaucoma (POAG) or ocular hypertension (OHT)
- Treatment naïve
- Had a baseline intraocular pressure (IOP) between 21-36 mm Hg
See here for complete inclusion/exclusion criteria.
And the setup?
Participants were randomized into one of two groups to receive either:
- Standard eye drops (0.5% timolol maleate)
- Administered via the original eye drop bottle into each eye
- n = 210
- Nanodropper-mediated microdrops (0.5% timolol maleate)
- Microdops dispensed into each eye from bottles installed with Nandropper Adaptors
- n= 214
What were the main outcome measures?
The primary outcome measure included: IOP (mmHg) at the following timepoints following drug administration:
- 1 hour
- 2 hours
- 5 hours
- 8 hours
Other outcome measures were resting heart rate (bpm) and resting systolic and diastolic blood pressure (sBP;dBP) at the same time points following drug administration.
And the final patient analysis total?
After excluding patients (n = 5) whose baseline IOP was below 21 mmHg and whose data was missing, 419 patients were included in the analysis (207 conventional eye drops and 212 microdrops).
So what were the overall findings?
In all, Nanodropper reported that there was no clinically significant difference in the IOP-lowering effects of Nanodropper-administered microdrops vs conventional eye drops.
This was true for all time points (hours 1, 2, 5, and 8).
Which time point had the largest IOP decrease?
The largest mean IOP reduction occurred at hour 5 following administration, according to the study authors. This was also the time point in which there was the largest between-group difference (0.71 mm Hg).
Give me some supporting data for hour 5.
- Conventional eye drop delivery decreased IOP by:
- 8.53 mm Hg (95% Confidence interval [CI]: 9.15 to 7.90 mm Hg) relative to baseline
- From 27.24 ± 4.61 mm Hg to 18.71 ± 4.79 mm Hg
- Mean percentage decrease: 30.91%
- 8.53 mm Hg (95% Confidence interval [CI]: 9.15 to 7.90 mm Hg) relative to baseline
- Nanodropper-administered eye drop delivery decreased IOP by:
- 7.78 mm Hg (95% CI: 8.40 to 7.17 mm Hg)
- From: 27.21 ± 4.37 mm Hg to 19.42 ± 4.24 mm Hg
- Mean percentage decrease: 27.97%
- 7.78 mm Hg (95% CI: 8.40 to 7.17 mm Hg)
Did the study meet non-inferiority criteria?
Yes! The investigators noted that the results met this criteria at hours 1, 2, and 8, but not hour 5— “where the upper limit of the 95% CI for the difference in mean IOP comparing timolol microdrops to conventional drops exceeded our non-inferiority margin of 1.5 mm Hg by 0.08 mm Hg.”
What happened with the other outcomes?
For both groups, the mean resting sBP significantly decreased at all timepoints except for hour 8, with no significant difference between the groups.
With dBP, conventional drops significantly decreased the mean resting dBP at hour 2, while the Nanodropper microdrops significantly decreased dBP at hours 2 and 5 (and no significant difference was noted between the groups either).
And the heart rate?
Once again, both groups significantly decreased the mean resting HR (relative to pre-drug baseline) at all time points; the largest decrease was noted at hour 2 for both as well.
Meaning: There may be an enhanced safety profile of using a microdrop vs conventional eye drops, according to Nanodropper.
Any limitations?
Several were noted, including the investigators’ inability to evaluate subject performance/usability of the Nanodropper (due to an ophthalmic technician administering the eye drops).
See here for more.
Take home.
"Eyedrop size has not seriously been commercially addressed in the past," stated Alan L. Robin, MD, corresponding author of the study.
The authors further wrote that they believe that “microvolume delivery technologies might offer potential solutions in the form of less waste and better safety profiles in various other ophthalmic subspecialties.
And the conclusion …
Overall, the use of the Nanodropper Adaptor provided comparable IOP-lowering efficacy “with a slightly lesser effect on resting cardiovascular parameters,” the authors stated. They concluded: “The results of this study present the adaptor as a tool to optimize topical management of ophthalmic conditions.”