Regener-Eyes� Ophthalmic Solution: A New Therapeutic Agent to Relieve Dryness of the Eye for Tear Hyperosmolarity-Induced Pathological Changes in the Eyes of Patients Suffering From Dry Eye Discomfort

Review Article

Austin J Clin Ophthalmol. 2023; 10(4): 1151.

Regener-Eyes® Ophthalmic Solution: A New Therapeutic Agent to Relieve Dryness of the Eye for Tear Hyperosmolarity-Induced Pathological Changes in the Eyes of Patients Suffering From Dry Eye Discomfort

Carl Randall Harrell*

Regenerative Processing Plant, LLC, United States of America

*Corresponding author: Carl Randall Harrell Regenerative Processing Plant, LLC, 34176 US Highway 19 N, Palm Harbor, FL34684, Florida, USA. Tel/Fax+1 800-781-0818 Email: [email protected]

Received: February 28, 2023 Accepted: March 29, 2023 Published: April 05, 2023

Abstract

Tear hyperosmolarity is an initial and crucial step in the development, progression and aggravation of dry eye discomfort. Decreased tear secretion or altered tear composition leads to tear film instability/imbalance which in Dry Eye (DE) patients results in abnormally rapid breakup of the tear film after blinking. Numerous structural changes in epithelial cells and mucin-producing goblet cells develop as a consequence of exposition of these cells to the hyperosmolar tears. Tear hyperosmolarity causes oxidative stress, disruption of DNA repair system and induces DNA damage in the cells of ocular surface and lacrimal system, leading to their apoptosis. An injury of lacrimal glands results in decreased tear secretion, enabling the creation of “positive loop” that leads to the DE progression and aggravation. Accordingly, eye drops, which alleviate tear hyperosmolarity and restore tear homeostasis at corneal surface, will break up vicious DEcycle and will relieve eye pain, irritation, discomfort, and vision disturbance in DE patients. Regener-Eyes® Ophthalmic Solution is a hypotonic solution enriched with osmoprotectants (that address the hyperosmolarity of a tear film), which helps support tear stability and contribute to relieve dryness of the eye in DE patients. In this article, we summarized current knowledge and future perspectives about topical administration of Regener-Eyes® Ophthalmic Solution to relieve dryness of the eye in DE patients.

Keywords: Tear hyperosmolarity; Eye drops; Eye inflammation; Therapy; Dry eye

Introduction

Dry Eye (DE) disease, also known as keratoconjunctivitis sicca or dysfunctional tear syndrome, is a common, multifactorial disease of the lacrimal system and ocular surface characterized by a deficiency in quality and/or quantity of the tear fluid [1].

Since the ocular surface is highly exposed to environmental hazards, efficient tear production and optimal tear turnover is essential for appropriate eye function [2]. The tear film, lacrimal glands (main and accessory lacrimal glands), meibomian glands (oil-producing glands positioned along the edge of the eyelids that create oily layer outside of the tear film, keeping tears from drying up too quickly), mucin-producing goblet cells, ocular surface secretory cells, lacrimal outflow pathways, corneal and conjunctival epithelial cells work together and function as a Lacrimal functional Unit (LFU) to maintain the tear film, protect the transparency of the cornea and the integrity of the ocular surface [3]. Importantly, the LFU is not an isolated system, and it functions in association with nervous and endocrine systems. Damage of any LFU component and/or development of neural and endocrine disease (the dysfunction of sensory and motor nerves, hormone imbalance) will destabilize the tear film and will lead to the development of DE [1,3]. An unbalanced tear film is not able to provide sufficient nourishment or protection to the ocular surface and, therefore, usually results in permanent damage of the corneal nerve fibers, corneal and conjunctival epithelial cells [1,3].

Dry eye disease is often classified into two primary subtypes: Aqueous Tear-Deficient Dry Eye (ADDE), characterized by inefficiency or inability of the lacrimal glands to produce tears, and Evaporative Dry Eye (EDE), typically attributed to excessive evaporation of the tear fluid [4]. ADDE may have an autoimmune origin or is attributed to a compromise in the LFU integrity [4]. EDE is the more common form of dry eye disease and is frequently associated with Meibomian Gland Dysfunction (MGD) characterized by modification or reduction of tear fluid lipids, due to which, integrity and quality of the tear fluid may be compromised [4]. Although traditionally, dry eye disease has been classified into these two subtypes, there is considerable overlap between them. As such, dry eye disease is the most often characterized as a "hybrid" or "mixed" form of these two subtypes, where in each subtype adopts some clinical features of the other, initiating and exacerbating its pathology [4].

Multifactorial nature of dry eye disease involves several inter-related underlying pathologies, including the loss of homeostasis, chronic eye inflammation, instability and hyperosmolarity of the tears which leads to the neurosensory dysfunction and visual disturbance [1,5]. These detrimental events create a “pathological loop" which promotes progression and aggravation of dry eye disease [1]. DE is usually manifested by dryness, grittiness, scratchiness, soreness, irritation, burning, watering, foreign body sensation, eye fatigue and reduced functional visual acuity [5,6]. Since significantly impaired performance of vision-dependent daily activities diminishes quality of life of dry eye disease patients, better understanding of pathological steps in dry eye disease pathogenesis is of crucial importance for appropriate dry eye disease treatment [1,6].

Tear Hyperosmolarity: An Initial and Crucial Step in the Development, Progression and Aggravation of Dry Eye Disease

Decreased tear secretion or altered tear composition leads to tear film instability/imbalance which in dry eye disease patients results in abnormally rapid breakup of the tear film after blinking [7]. This leads to local drying and hyperosmolarity of the exposed surface which provokes cell death, injury of LFU components and induces a cascade of detrimental inflammatory events, resulting in eye pain, irritation, discomfort, and vision disturbance in dry eye disease patients (Figure 1) [4,8].

Citation: Harrell CR. Regener-Eyes® Ophthalmic Solution: A New Therapeutic Agent to Relieve Dryness of the Eye for Tear Hyperosmolarity-Induced Pathological Changes in the Eyes of Patients Suffering From Dry Eye Discomfort. Austin J Clin Ophthalmol. 2023; 10(4): 1151.