Current standard of care is to apply mitomycin C that is locally provided by the pharmacies at the time of surgery during trabeculectomy surgery. This technique while improves the success rate , can also result in increased complications. There is no current standard to reduce postoperative fibrosis following glaucoma drainage devices.
Mitosol is a clean MMC powder that Mobius corporation from St. Louis ,MO supplies in a special package to be mixed at the time of surgery and applied one time (just like the pharmacy mixed MMC). This is a 10 million dollar company that can be potentially considered to be the market competitor. However, this is not a slow release drug delivery system, contains only MMC and is still associated with all the complications of regular MMC application and contains no 5 FU. As such, we felt that this is really NOT a competition. There really is no product in the market that is comparable to ElutiGlass .
ElutiGlass is the first of its kind in the space of slow release antifibrotic drug delivery system target glaucoma filtration surgery and glaucoma drainage device surgery. These conventional glaucoma surgeries are considered the gold standard for patients with advanced glaucomas and secondary glaucoma such as NVG, UG and Traumatic glaucoma. These account for 40% of the glaucoma market share and the global market share for 2016 was $ 108 million (per marketscope 2016 report) or 28% of the total market revenues for the global glaucoma surgical market. Marketscope forecast that these drainage device revenues will increase to $175 million by 2021, up from $108 million in 2016 at a CAGR of 10 percent.
As the first slow release drug delivery system that targets fibrosis, we believe that ElutiGlass will attract wide acceptance with in the ophthalmic community, especially since its application does not require any special training.
ElutiGlass is the first of its kind that combines the antifibrotic action of MMC and 5 FU released in small but sustained quantities and in sequence on exposure to aqueous humor. It is made of a biodegradable polymer (PLGA) that is cast using a specially to create a breath figure with the MMC suspended on the surface and 5 FU within the body of the device. This device is placed into the operative site at the time of surgery ( on surface of GDD plate ; adjacent to the trabeculectomy scleral flap). On contact with aqueous humor, MMC will be released in the first 24 hour followed by 5 FU over the next 23-30 days in a slow and sustained format. The drugs are designed to be released to time the migration of fibroblasts at the surgery site thus killing these cells on contact and preventing (or decreasing) post operative fibrosis. This decreased fibrosis may mean improved IOP control that is long lasting. Following the release of the drugs, the polymer itself will disappear completely via bio absorption.
The main functions of ElutiGlass are 1. Anti fibrosis 2. Decrease postoperative fibrosis 3. Minimize post operative complications (prevent thin cystic bleb formation) 4. Bio absorption of the polymer following the release of the drugs without any side effects. All of these targets have been proven to be true in the animal models.
Indications: 1. Trabeculectomy 2. Glaucoma drainage devices 3. Express shunt 4. Minimally invasive surgeries such as In focuss
Glaucoma affects 3 million Americans. 120,000 Americans are blind from glaucoma. It is the 2nd leading cause of blindness worldwide with 80 million affected worldwide and 10 million blind worldwide. The primary pathogenesis relates to elevated eye pressure ( intraocular pressure or IOP) secondary to obstruction in the natural drainage pathways ( junction between the trabecular meshwork and Schlemms canal). Uncontrolled IOP leads to damage to the ganglion cells of the retina and the optic nerve leading to blindness.
Primary focus of treatment is reduction of the eye pressure. This could be achieved with the help of topical or oral medications which are effective in reducing the eye pressure in majority of patients with mild and moderate glaucoma. Patients with advanced glaucoma and those that are secondary to other pathology (ex: neovascular glaucoma , uveitic glaucoma, traumatic glaucoma etc ) need some kind of surgery to divert the eye fluid (aqueous humor) out of the eye to achieve the target IOP. Diversion of aqueous humor into the subconjunctival tissues (tissues with in the eyewall) is achieved with either hole in the eye wall which is regulated by a trap door mechanism (trabeculectomy) or via a silicone tune attached to a plate (glaucoma drainage devices). These surgeries fail at the rate of 10% /year secondary to postoperative fibrosis. One time application of antifibrotic agents such as mitomycin C is commonly used to decrease the postoperative fibrosis following trabeculectomy with improved success rate. However, this is accompanied by unwanted complications such as thin blebs and leaky roofs of the blebs that can get infected. Mitomycin C (or any other drug) application does not appear to influence the outcomes of GDD surgery.