Eyegate Pharmaceuticals Inc (NASDAQ:EYEG) investors have a smile on their faces Friday morning, after the healthcare firm announced that the FDA has permitted the company’s ocular bandage gel (OBG, hydrogel eye drop with 0.75% CMHA-S), based on the cross-linked thiolated hyaluronic acid (CMHA-S) platform, to pursue U.S. regulatory clearance as a device through the de novo 510(k) pathway.
Eyegate shares reacted to the news, jumping nearly 21% to $1.75 in early trading Friday. EYEG has a 1-year high of $5.10 and a 1-year low of $1.11. The stock’s 50-day moving average is $1.67 and its 200-day moving average is $2.38.
“We are extremely encouraged by our dialogue thus far with the FDA around EyeGate OBG, and are pleased to have a clear clinical and regulatory path forward for our first-in-kind eye drop that could accelerate recovery from post corneal surgery and injury,” said Stephen From, President and Chief Executive Officer of EyeGate. “We believe that the De Novo process, which is for medical devices without predicates, provides evidence of the novelty of our EyeGate OBG product. We look forward to announcing the top-line data from our PRK pilot study by the end of the year.”
On the ratings front, H.C. Wainwright analyst Ram Selvaraju reiterated a Buy rating on EYEG, with a price target of $10, in a report issued on October 24. The current price target implies an upside of 441% from current levels. According to TipRanks.com, Selvaraju has a yearly average loss of 3.2%, a 37% success rate, and is ranked #3915 out of 4229 analysts.
EyeGate Pharma is a clinical stage pharmaceutical company that is focused on developing and commercializing therapeutics and drug delivery systems for treating diseases of the eye. Its Products include EGP-437 and EyeGate II Delivery System. EGP-437 for the treatment of non-infectious anterior uveitis, a debilitating form of intraocular inflammation of the anterior portion of the uvea, such as the iris or ciliary body. The EyeGate II Delivery System features a compact, elegant, and easy-to-use device that delivers drugs non-invasively and quickly into the ocular tissues through the use of iontophoresis, which can accelerate the onset of action, dramatically reduce treatment frequency versus eye drops and sustain therapeutic effect.