OphRx – Non invasive topical drug delivery technology
OphRx develops products based on a novel drug delivery technology platform for ocular uses
OphRx, our joint venture which is developing eye drops based on a non-invasive drug delivery technology that utilizes lyotropic liquid crystals, or LLC, as an alternative to the current delivery modalities, such as intravitreal injections, used to treat diseases at the back of the eye. This platform technology can also be used for front of the eye treatments. OphRx is currently in the preclinical stage of development of two product candidates: OPH-101, an alternative topical treatment to intravitreal injections for wet AMD, 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, or front segment of eye, and do not reach the posterior, or back segment of the eye. The posterior segment of the eye (retina, vitreous, choroid) can be treated by a high drug dosage regimen given intravenously or by intravitreal administration or implants or by periocular injections. The injections have several drawbacks: they are invasive, create significant discomfort and are expensive, and some patients have experienced detached retinas and serious infections inside the eye as a result. 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 30 to 50 million people worldwide, of which 15 million are in the United States, with 600,000 new cases diagnosed every year globally, of which over 200,000 are in the United States.
According to Research and Markets, in 2012 DES therapeutic sales were approximately $1.6 billion across the nine largest markets: the United States, France, Germany, Italy, Spain, the United Kingdom, Japan, China and India, 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 is currently in the pre-clinical stage of development of two product candidates: OPH-101, an alternative topical treatment to intravitreal injections for wet AMD, and OPH-100, a treatment for DES.