How will Pharmacotherapies help the growing number of Presbyopes?

Presbyopia is the gradual loss of near-focusing ability that occurs with age—a condition that occurs when people get older and prevails as a quite common one in many individuals. The reasons for this lack of accommodation power are undetermined. It is commonly assumed that this is due to the lens being less elastic over time. The term “Presbyopia” is derived from the Greek word “elderly vision.” The condition continues to worsen until the age of 65 when the eyes’ lenses have lost most of their elasticity. Presbyopia develops gradually, and those affected can experience a proclivity to keep reading materials further away from one’s face to see the letters more clearly, and at a standard reading distance, vision gets blurred, especially after 40. Other than this, after reading or doing close-up work, one can experience eye pressure or headaches. Read here more about other eye disorders that continue to increase the global healthcare burden.

“As per American Optometric Association, Presbyopia is expected to impact approximately 123 million US residents by 2020. As the geriatric population is projected to grow in the United States, this disease will become more common with age; hence, DelveInsight’s analysts estimate that the prevalence rate will rise as well.”

To detect Presbyopia, a simple and thorough eye examination with a bunch of different tests is required. The ophthalmologist can perform muscle integrity, refraction, slit-lamp, visual field, and visual acuity tests on the retina; these will assist in determining the condition. Patients can report increased sensitivity to light in the hours following the exams due to the eye drops used to dilate the pupils.

Current clinical management in the Presbyopia treatment market includes usage of the off-label treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), parasympathetic agonists, miotic agents, or some other tempering agents. The most commonly used agents are Pilocarpine, Carbachol, Aceclidine, Brimonidine, Nepafenac, etc. Besides, several types of refractive surgical procedures, including Conductive Keratoplasty, LASIK (laser-assisted in situkeratomileusis), LASEK (Laser-assisted subepithelial keratectomy), and Photorefractive Keratectomy, are also available for the management of Presbyopia. On the other hand, spectacles are the most cost-effective, simple, and inexpensive means of correction, especially in developing countries where other options are unavailable. However, there are obstacles to their use; for example, these can be quickly misplaced, damaged, or broken.

Gaps in the Treatments

According to the World Health Organization’s prioritization for providing Presbyopia facilities, the responsibility of unmet Presbyopia needs is a high priority. To resolve the backlog of unmet Presbyopia correction needs, efficient and cost-effective spectacles must be combined with health education and promotion activities. It is imperative to make people aware of this common prevailing condition that causes a major impact in developed and developing countries, especially in rural areas.

A majority (~3/4th cases) of the Presbyopia patients use eyeglasses to correct close-up vision problems. As per DelveInsight’s analysis, in terms of revenue, eyeglasses consisted of nearly half of the US Presbyopia treatment market in 2018.

All current care options are either inconvenient or invasive, posing a major unmet need for people with presbyopia to enhance their quality of life. There is a lack of the United States Food and Drug Administration (FDA) or European Medicines Agency (EMA)-approved pharmacological options. Besides, off-label eye drops such as pilocarpine do not exactly treat the underlying cause of Presbyopia but help treat its symptoms.

In terms of pharmacological treatment availability, Presbyopia is an untapped sector. Nevertheless, this sector possesses a more significant Presbyopia treatment market opportunity, and recently some developmental initiatives have been taken toward the management of Presbyopia.

Presbyopia Treatment Market  & Key Players

Companies like Eyenovia [MicroLine (Pilocarpine Ophthalmic)], Orasis Pharmaceuticals [PresbiDrops (CSF-1)], Allergan (acquired by AbbVie) (AGN-190584, and AGN-241622), Novartis [UNR844 (Lipoic acid choline ester, EV06)], Ocuphire Pharma (Nyxol + Pilocarpine), and Visus Therapeutics [VTI-001 (Brimochol)], and several others are investigating their candidates in the Presbyopia pipeline.

AGN-190584 is an interventional optimized formulation of pilocarpine, being developed by Allergan, an AbbVie Company, a cholinergic muscarinic receptor agonist that stimulates muscarinic receptors localized at smooth muscles such as the iris sphincter muscle and ciliary muscle, is being studied as a topical, once-daily decrease administered by a proprietary vehicle for the treatment of Presbyopia. As per the latest published data, AGN-190584 met its primary endpoint in the Phase III studies GEMINI 1 and GEMINI 2. Another candidate of Abbvie for Presbyopia is AGN-241622. It has already been tested in a Phase I/II clinical trial.

In addition to this, PresbiDrops (CSF-1) is an eye drop developed by Orasis Pharmaceuticals to help people with Presbyopia improve their quality of life by offering an alternative to reading glasses intrusive surgical procedures. CSF-1 is a topical treatment applied directly to the eyes and includes a patented blend of current and well-studied ingredients that can help people with Presbyopia regain their near vision. To date, clinical trial findings have shown substantial changes in close vision and a superior safety record, supporting possible quality of life improvement in patients with Presbyopia. Furthermore, Eyenovia’s patented pilocarpine formulation for Presbyopia is MicroLine. Pilocarpine is a well-studied ophthalmic medication. Numerous research demonstrates its potential to enhance close vision by increasing the eye’s depth of focus and counteracting the age-related loss of accommodative impact. MicroLine is designed to provide “on-demand” symptomatic care for Presbyopia-related near vision impairment.

Novartis is also investigating a treatment option for presbyopia. UNR844 (formerly known as EV06) is a lipoic acid choline ester that could be a first-in-class disease-modifying topical for the treatment of presbyopia. The therapy has already been assessed in the Phase I/II clinical trial study. Moving on, Nyxol is a nonselective alpha-adrenergic antagonist from Ocuphire pharma that prevents the contraction of iris smooth muscle. It is a preservative-free ophthalmic solution. Nyxol decreased pupil diameter in several Phase II experiments, resulting in improved contrast sensitivity and visual acuity.

Brimochol, a patented formulation combining two FDA-approved pharmaceuticals: carbachol and brimonidine tartrate, is Visus’ lead product candidate. Visus Therapeutics has announced the launch of a novel eye drop intended to restore close vision loss caused by disease, as well as a clinical development program.

In a nutshell, with the introduction of the emerging therapies in the Presbyopia treatment market, it is believed that it is going to cause a positive impact in the lives of the patients dealing with this vision impairment issue. Upcoming therapies are expected to slow down or halt the progression of presbyopia. In addition to this, reduced dosing frequency and controlled volume of solution should improve compliance and cause less toxicity.