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Ophthalmology is known for being 10 steps ahead on the path of ground-breaking technology. A glimpse at the current pipeline confirms the field’s impressive footprint. For instance, EyeGate is developing a unique drug-delivery Iontophoresis system and a promising ocular bandage polymer platform that are rapidly making their way through the regulatory process. Here we chat with EyeGate’s President and Chief Executive Officer Stephen From, and the company’s Chief Medical Officer, Barbara Wirostko, MD, about the EyeGate II Delivery System (EGDS) and the company’s novel crosslinked thiolated hyaluronic acid (CMHA-S) ocular bandage platform’s road ahead.
Stephen From: The iontophoresis delivery system is essentially a non-invasive method of propelling a drug into ocular tissue. The system utilizes a low-level electrical current to deliver a specified amount of drug for each treatment. We originally licensed this technology from the University of Miami, and today Valeant Pharmaceuticals Inc. (through its subsidiary Bausch + Lomb), has an exclusive license to manufacture, sell, distribute and commercialize the system for the delivery of EGP-437 (corticosteroid) throughout the world for uveitis.
AOC: How does EGDS iontophoresis work?
Mr. From: Iontophoresis is based on a very simple concept of like charges repelling. The system comprises a cup which contains a foam reservoir that gets saturated with the drug product. The wet saturated foam sits on the surface of the eye covering the sclera, and the other end of the foam is sitting next to an electrode which is attached to a small, hand-held generator. The process involves applying a tiny electrical current to the electrode. It is important that the drug product has a charge and that the current going to the electrode has the same charge as the drug product. Once we apply the charge to the electrode, the drug having the same charge as the electrode will repel away from the electrode and towards the surface of the eye. The drug has nowhere to go but into the eye and the ocular tissue. We control how much drug leaves the cup and goes into the eye with two variables: the amount of current and the duration of the current. The process takes anywhere from 1 to four minutes; we are getting excellent results.
AOC: What are the benefits of iontophoresis over drops and injections?
Mr. From: The main benefit is that we are delivering a drug noninvasively into the ocular tissue. Another benefit is that it is capable of delivering substantially higher drug concentrations than traditional topical applications, leading to greater bioavailability, more sustained therapeutic effect and reduced frequency of dosing. Iontophoresis overcomes one of the key limitations of eye drops, which is patient compliance. Based on the current standard of care for anterior uveitis, patients need a minimum of 154 treatments of a topical corticosteroid delivered via drops over a 4-week period. In a phase 3 non-inferiority trial comparing our treatment to standard of care topical steroid drops, we achieved the same rate of response as the standard of care in only two treatments, with fewer incidences of elevated IOP.
AOC: What drugs can it be used to deliver and what are the main indications?
Mr. From: We are working with EGP-437 dexamethasone phosphate, a corticosteroid, and our main indication is anterior uveitis. We’re also investigating its use for postcataract surgery inflammation and pain, as well as macular edema. If a drug is soluble and has a charge, it can be delivered with the EGDS.
AOC: How safe is it?
Mr. From: More than 2,000 eyes have been treated with this device, and all we have seen is transient hyperemia. It is both patient friendly and user friendly.
Barbara Wirostko, MD: The safety profile has been quite exceptional. An important element is that we are loading the tissue with a one-delivery dose, so we are avoiding all of the preservatives and epithelia toxicity associated with multiple daily topical eye drops. We work very closely with ophthalmic eye care providers in many states and the fact that optometrists can deliver this treatment and help comanage patients is key.
AOC: Is this an opportunity for a cooperative approach between ophthalmology and optometry?
Mr. From: Yes, this offers another opportunity for optometrists to be involved in the shared care of patients. There are a lot of large ophthalmic practices that have optometrists onsite, and we could see them, under the supervision of an ophthalmologist, being the practitioner who performs these treatments. Also, there will be a CPT code that will be dedicated to this treatment, so it represents a new revenue stream for both optometrists and ophthalmologists.
AOC: Where is Iontophoresis in the pipeline and what are the next steps?
Mr. From: We are aiming to finish enrollment for our second phase 3 trial for uveitis towards the middle of 2017, and we’ll probably finish our phase 1b/2a post-cataract surgery inflammation study in late 2016. Then we’ll move on to a phase 2b study for cataract surgery. Regarding macular edema, we are exploring our options as were able to show in all different subgroups that we could get the edema reduced in the retina with just two treatments a few days apart; however, the drug is a small molecule and it clears very rapidly. When it clears, the edema returns. In general, we see no increase in IOP, and this is unique to the way the steroid is being delivered. We’re looking at some other drugs, as well, but they’re in a much earlier stage.
AOC: Describe the CMHA-S platform and its relationship to Jade Therapeutics.
Mr. From: CMHA-S, which stands for cross-linked thiolated hyaluronic acid, is essentially another drug delivery solution. It was being developed for ocular uses in humans by Jade Therapeutics, which was founded by Dr. Wirostko, and is now a wholly owned subsidiary of EyeGate. The CMHA-S product that we are working with first, is an ocular bandage gel that is applied as an eye drop. It is intended for the management of corneal epithelial defects and for the acceleration of re-epithelization of the ocular surface following a variety of epithelial defects. There is nothing like it on the market in the United States, and we’d like to be the first ones to offer it. We expect there to be widespread use of this device by ophthalmologists and optometrists for a variety of corneal and ocular surface injuries.
AOC: What role does hyaluronic acid play?
Mr. From: HA promotes wound healing and we cross link it which slows down the degradation of the polymer and allows us to put it into a liquid form that we call LiquiGel. We are currently undergoing studies to demonstrate the duration of retention on the eye, which we believe will be hours without any ocular blurring.
Dr. Wirostko: HA has a long history of being used as a device for dermal wound healing throughout the world in dermatology. There are numerous products that have been regulated and are on the market to help heal the epithelial layer of dermal tissue. This product basically coats the ocular surface and forms a cross-link meshwork, but remains clear so vision isn’t blurred. It actually interacts with mucin to protect the surface.
AOC: What are possible indications for the LiquiGel bandage?
Dr. Wirostko: We are aiming for an indication of accelerating re-epithelialization of the ocular surface in the cornea following trauma, surgery, injections or injuries -- essentially anything that could irritate injured ocular surface. It could be used for be something as simple as an exposure keratopathy, to chemicals in the eye, to surgical PRK, to a military battlefield. It could be used, for instance, for a large corneal abrasion, where the patient would need antibiotic drops, but the Liquigel would go first, help accelerate healing, and be followed by topical antibiotics.
Mr. From: Our initial pilot study is for large epithelial defects that occur as a result of PRK surgery. We hope to have the topline data in the near future.
AOC: What can you tell us about safety and efficacy of the LiquiGel bandage so far?
Dr. Wirostko: We always take a step back and ask, “why do we believe in this product?” And one key element is that this product is already on the market, sold globally in the veterinarian space for exactly this indication, marketed by Bayer DVM. It has demonstrated an excellent efficacy and safety profile. n