Eyenovia offers results of study evaluating microdose delivery technology

According to the in vitro study design, conjunctival epithelial cells were exposed to drug by standard drop or the microdose technology

Eyenovia Inc. today announced positive results from a research study conducted in collaboration with Pedram Hamrah, MD, interim chairman of Ophthalmology at Tufts Medical Center, which evaluated the gene and protein expression of cytokines and chemokines after latanoprost+benzalkonium chloride (BAK) treatment administered via the company’s microdose formulation and delivery platform (Optejet) versus latanoprost+BAK administered via standard eye drops.

According to a news release from Eyenovia, preservatives are used to support product sterility and prolong shelf-life. Unfortunately, patients treated with BAK preserved glaucoma medications often suffer inflammatory side effects and develop subsequent ocular surface disease.

“Chronic treatment of glaucoma with BAK preserved topical ophthalmic medications introduces ocular surface stress and may trigger a vicious cycle of inflammation,” Hamrah said in the news release. “Unfortunately, the majority of glaucoma patients treated long term with drops eventually succumb to the associated inflammatory effects and discomforts of ocular surface disease.”

According to the in vitro study design, conjunctival epithelial cells were exposed to drug by standard drop or the microdose technology. Assays were then conducted to assess inflammatory Gene expression via RT-qPCR and Protein expression by ELISA. These assays targeted the common immune biomarkers and ocular surface disease inflammatory mediators such as IL6 and MIF cytokines as well as the chemokine CCL2.

The company noted that the study found that the expression of pro-inflammatory cytokines and chemokines was decreased in two out of three cytokines with the latanoprost+BAK treatment administered via microdose formulation and delivery platform technology compared to latanoprost+BAK administered via standard drops. In these early findings, the microdose formulation and delivery platform technology appears better than latanoprost+BAK administered via standard drops in reducing inflammatory processes and pathways.

Julie Whitcomb, PhD, senior director of Medical Affairs at Eyenovia, pointed out that the microdose formulation and delivery platform technology exhibits lower levels of proinflammatory cytokines and chemokines than standard drops.

“The current study further underscores that precision dosing of drug and preservatives by the Optejet decreases inflammation,” she said.

Tropicamide 1% and phenylephrine 2.5% ophthalmic spray (Mydcombi) is Eyenovia's investigational, first-in-class fixed-dose-combination product for pharmacologic mydriasis (eye dilation), which is targeted to improve the efficiency of the estimated 100 million office-based comprehensive eye exams performed every year in the United States, as well as the estimated 4 million pharmacologic mydriasis applications for cataract surgery.

Developed as a micro-formulation for use without anesthetic, Eyenovia said in the news release it believes tropicamide 1% and phenylephrine 2.5% ophthalmic spray will help improve the efficacy, tolerability, and efficiency of pharmacologic mydriasis.