OphRx – Noninvasive topical drug delivery technology
OphRx develops products based on a novel drug delivery technology platform for ocular uses
OphRx, our joint venture is developing eye drops. Based on lyotropic liquid crystals (LLC) drug delivery technology. As LLC, a noninvasive alternative to current delivery modalities used to treat diseases at the front and the back of the eye, such as intravitreal injections. OphRx is currently in preclinical development stage of two product candidates: OPH-101, wet AMD topical treatment as an alternative to intravitreal injections, and OPH-100, a treatment for DES.
Ophthalmic drug delivery is one of the most challenging endeavors facing the pharmaceutical scientist. The anatomy, physiology, and biochemistry of the eye render this organ highly impervious to foreign substances. Drug delivery to the eye can be broadly classified into anterior (front) and posterior (back) segments. Conventional systems like eye drops, suspensions, and ointments mainly target the diseases in the anterior segment, and do not reach the posterior one. The posterior segment of the eye (retina, vitreous, choroid) can be treated systemically by a high drug dosage regimen given intravenously or by eye-penetrating methods such as intravitreal administration or implants or by periocular injections. The injections have several drawbacks: they are expensive, create significant discomfort to the patients, and for being invasive, increasing the risk for retina detachment and serious infections inside the eye.
Consequently, there is a significant unmet need for a non-invasive drug delivery system for the posterior segment, which circumvents the protective barriers of the eye without causing permanent tissue damage, while delivering an optimal concentration of a drug at the active site for the appropriate duration.
- AMD – is a leading cause of vision loss and irreversible blindness among people aged 50 and older. AMD causes damage to the macula, a small spot near the center of the retina which enables us to see objects that are straight ahead. It is estimated to affect 180 million people worldwide, with highest prevalence is in Europe (18%), and lowest in Asia (7%). 10% of the AMD patients (~18 million) suffer from the more severe form, ‘wet’ AMD, of which over 2 million are in the US alone. The market value of wet AMD is estimated at ~$5.8B and forecasted to grow at 7.5% p.a. from 2016-2022.
- DES – Dry Eye Syndrome is a heterogeneous group of conditions characterised by tear film insufficiency and ocular irritation and is estimated to affect between 5-35% of the adult population worldwide.
According to Research and Markets, in 2012 DES therapeutic sales were approximately $1.6 billion across the nine largest markets and by 2022 sales will grow to $5.5 billion at a compound annual growth rate, or CAGR, of 12.8%. The majority of the current DES drug sales are in the United States although China and India have the largest number of DES patients. There is only one FDA-approved prescription medication used to treat DES — Restasis, an immunosuppressive agent approved to treat inflammation, which is used to treat chronic dry eye that may be caused by inflammation. Although the product has limited efficacy as a treatment for DES, according to the Allergan Inc.’s 2014 Annual Report, it had total U.S. drug sales of more than $1 billion in 2014. A clinical trial funded by Allergan Inc. noted that eye drops increased tear production in only 15% of patients, compared with 5% of patients in the placebo group.
OphRx offers an alternative to intravitreal injection, improving patient satisfaction through saving time, effort, risk and cost. OphRx also affords greater control to the patient through self-administration.
OphRx’s is leveraging approved APIs, enabling potentially shorter time to market. Its technology is underpinned by two well-researched mechanisms which improve drug delivery: transmembrane drug delivery and targeted-release. These mechanisms have been successfully demonstrated at a commercial level.