A phase 3 trial of EyeGate Pharmaceuticals’ EGP-437 for the treatment of noninfectious anterior segment uveitis failed to demonstrate non-inferiority to a control group.
Image: EGP-437 showed clinical efficacy in reducing anterior chamber cell score. Photo: courtesy of Stuart Miles at FreeDigitalPhotos.net
The treatment, delivered via the EyeGate II drug delivery system, showed clinical efficacy in reducing anterior chamber cell score but did not demonstrate non-inferiority to a prednisolone acetate ophthalmic solution control group.
Non-inferiority was measured by the proportion of patients with an anterior cell count of zero at day 14, EyeGate said.
EGP-437 incorporates a reformulated topically active corticosteroid, Dexamethasone Phosphate that is delivered into the ocular tissues through the company’s drug delivery system.
EyeGate president and CEO Stephen From said even though the company is disappointed with the results of the Uveitis study, it will continue to review the data and assess the path forward for EGP-437.
From said: “This also represents an opportunity to shift our focus toward the key clinical trials that support our innovative Ocular Bandage Gel (OBG) product, which has the potential to benefit patients with corneal surface damage.”
EyeGate is actively enrolling for the photorefractive keratectomy and punctate epitheliopathy studies.
The company randomized the first three patients in the study assessing the ability of its Ocular Bandage Gel (OBG) to reduce corneal staining, an indication of ocular surface damage, in patients with punctate epitheliopathies (PE) due to pathologies such as dry eye.
EyeGate said randomization takes place if a patient meets specific clinical criteria following a two-week qualification period and then enter the treatment phase of the study.
The company has so far enrolled 34 subjects in the qualification stage. Enrollment will continue as 30 subjects are needed to qualify for the treatment stage.
EyeGate’s other ongoing OBG study which is for patients that have large corneal defects because of photorefractive keratectomy surgery is currently greater than 80% enrolled.
The top-line data from the trials is due to be released in the fourth quarter of 2018.
EyeGate is engaged in the development and commercialization of products using its two platform technologies to treat eye diseases and disorders.