Following positive data from its first Ocular Bandage Gel (OBG) pilot study, EyeGate Pharmaceuticals Inc (NASDAQ:EYEG) has filed an amended Investigational Device Exemption (IDE) application with the FDA for a second trial. If accepted, the OBG may return to human trials in Q218. Data readouts from the trials in H218 in addition to the ongoing Phase III study for EGP-437 could prompt key value inflection drivers.
Ocular Bandage Gel supports corneal health
EyeGate’s Ocular Bandage Gel is a topical eye drop based on its proprietary crosslinked thiolated carboxymethyl-hyaluronic acid (CMHA-S), a modified form of the natural polymer, hyaluronic acid (HA). HA has hydrating and healing properties when applied to the ocular surface, but it degrades rapidly. Through crosslinking, CMHA-S may adhere longer to the ocular surface and resist degradation. In Q117, EyeGate completed a pilot trial (n=39) of patients undergoing bilateral photorefractive keratectomy (PRK) surgery and found that at day 3, 83% of those receiving OBG had complete wound closure vs 54% in the standard-of-care arm.
Amended filing could lead to OBG studies in Q218
Prior to permitting the next OBG study to proceed, the FDA requested the filing of an IDE amendment detailing processes used in OBG’s manufacturing to eliminate sources that could lead to contamination or raise microbial burden risk. EyeGate anticipates it could start its next PRK study (in upto 45 subjects) in H118 and it also plans another pilot OBG study in punctuate epitheliopathies (in upto 30 patients), a common sign of moderate dry eye. Each study could report data in H218 potentially leading to pivotal studies that could drive a 510(k) de novo regulatory filing in 2019.
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