This morning, late-stage clinical specialty pharmaceutical company Eyegate Pharmaceuticals Inc. (EYEG:NASDAQ), which is focused on developing products for treating disorders of the eye, announced that "it has received select topline data, specifically the primary endpoint, demonstrating superiority over standard-of-care in its corneal wound repair pivotal study using the Ocular Bandage Gel (OBG) eye drop."
The company reported that "the results of this critical study demonstrated that EyeGate's OBG eye drop provided a greater improvement in corneal re-epithelialization than those treated with the standard-of-care, a bandage contact lens." The firm advised that the study was composed of 234 randomized subjects who received a large 9 mm corneal epithelial wound required for photorefractive keratectomy (PRK) surgery. EyeGate noted that next week it expects to receive additional topline data along with the full data package in mid-December.
Vance Thompson M.D., of Vance Thompson Vision in Sioux Falls, S.D. commented, "The proven effectiveness and well tolerated safety profile of EyeGate's OBG eye drop is a major step for the corneal wound repair market...I believe that the OBG eye drop will not only benefit patients with large corneal defects, but also patients with moderate to small corneal abrasions and epitheliopathies."
EyeGate's CEO Stephen From remarked, "We are thrilled with the results of this pivotal study...This allows us to submit a de novo application for commercialization, which we plan to do in H2/20. OBG, if approved, will be the first product indicated to repair corneal defects, as well as the first prescription Hyaluronic Acid ("HA") eye drop in the U.S., providing a huge opportunity for EyeGate."
EyeGate indicated that "its lead product, Ocular Bandage Gel (OBG), is based on a modified form of the natural polymer hyaluronic acid, which is a gel that possesses unique properties providing hydration and healing when applied to the ocular surface...the objective of OBG is to re-epithelialize the cornea, reduce the risk of infection, improve symptoms, and improve ocular surface integrity. Often current treatments fall short as they are ineffective in protecting and enabling corneal re-epithelialization."
The company stated in the release that "if EyeGate receives FDA approval following successful completion of the PRK pivotal study, it believes OBG will be the only prescription hyaluronic acid eye drop in the U.S. and the only eye drop in the U.S. approved for the healing of corneal epithelial defects."
EyeGate Pharmaceuticals is headquartered in Waltham, Mass., and is a late-stage clinical specialty pharmaceutical company focused on developing and commercializing therapeutics and drug delivery systems for treating eye disorders. EyeGate's leading product is Ocular Bandage Gel (OBG). The firm notes that it is currently working on clinical trials for two different patient populations: photorefractive keratectomy (PRK) surgery to demonstrate corneal wound repair; and punctate epitheliopathies (PE), which includes dry eye.
EyeGate is developing its other product EGP-437, which incorporates a topically active corticosteroid dexamethasone phosphate for treatment of various inflammatory conditions of the eye, including uveitis, a debilitating form of intraocular inflammation of the anterior portion of the uvea such as the iris and/or ciliary body, and macular edema, an abnormal thickening of the macula associated with the accumulation of excess fluids in the extracellular space of the neurosensory retina. EGP-437 is delivered into the ocular tissues through the company's proprietary innovative drug delivery system called the EyeGate II Delivery System, which is designed to deliver optimal quantities of drugs to the anterior or posterior segments of the eye.
EyeGate Pharmaceuticals started off today with a market capitalization of about $17.4 million with approximately 3.636 million shares outstanding. EYEG shares opened 85% higher today at $8.86 (+$4.79, +84.97%) over the prior day's closing price of $4.79. The stock set a new 52-week high price this morning and has traded today between $6.64 to $9.50 per share on very high relative volume. The shares are currently trading at $6.88 (+$2.09, +43.63%).[NLINSERT]
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