A clinical study has demonstrated the effectiveness of high-precision microdosing to administer topical medications accurately and effectively to the eye using piezo-print technology.
Eyenovia’s EYN PG21 study investigated the medication administration effectiveness and IOP lowering effect of microdose latanoprost 0.005% in 60 eyes of 30 healthy volunteers. After a brief medication administration training session, investigators say they successfully administered high-precision piezo-print latanoprost with a single spray 95% of the time. A separate evaluation of patient self-administration showed an 88% success rate following limited training, which they say is a substantive improvement from the 39%-47% success rate reported in the literature using a conventional eyedropper. In addition, the proof-of-concept study showed each single medication administration was within 1 µL of the prescribed dose and the tear capacity of the eye. This differs from traditional eyedropper administration, which may deliver as much as 300% more drug than the eye can hold with high variability of dosing.
The study results also demonstrated that, while reducing drug administration volume by 75% by delivering the microdose accurately and directly on the corneal surface, piezo-print micro-formulated latanoprost achieved a very robust reduction in diurnal IOP of up to 29% from baseline unmedicated IOP. This is consistent with the reported reduction of up to 26% achieved with the same concentration of standard latanoprost eye drops.
University of California ophthalmology professor Dr Robert Weinreb, says, “microdosing can open a new chapter in topical eye disease therapy with high-precision microdosing that dramatically improves the therapeutic index of many front-of-the-eye therapies.” He says further studies have the potential to introduce a new wave of formulations with improved safety, tolerability and smart-compliance monitoring.
Harvard Medical School Professor of Ophthalmology, Dr Louis Pasquale, commented, “Conventional eye drops may overdose the eye’s tear film capacity by as much as 300%, causing significant ocular and systemic side effects leading to hyperemia, sunken globe (peri-orbitopathy), pharmacologic dermatitis and bradycardia, and ultimately the poor compliance that plagues almost all front-of-the-eye treatments. Microdosing has the potential to address all those problems by providing physiologic high-precision dosing to the eye that stays in the eye.”
