Foresight Biotherapeutics, Inc. announced completion of a multi-center open-label pilot study of FST100 in the treatment of viral conjunctivitis. FST-100 is a novel formulation of dexamethasone that includes povidone iodine. The trial studied patients with clinical signs and symptoms of acute conjunctivitis who tested positive for adenoviral antigen by the RPS Adeno Detector® (RPS). Patients were enrolled in a single arm utilizing FST-100 topical ophthalmic suspension given 4 times daily for 5 days. The RPS Adeno Detector® test was performed at baseline and at each visit along with conjunctival swabs for adenoviral titers by quantitative PCR (qPCR) and cell culture with confirmatory immunoflourescence (CC-IFA). The primary endpoint of the study was clinical resolution of conjunctival injection and conjunctival discharge. These signs were scored on a scale from zero to three. Secondary endpoints included reduction of viral titers measured by qPCR and eradication of infectious virus determined by CC-IFA. FST-100 met the primary endpoint of the study by demonstrating complete resolution of conjunctivitis signs (a score of zero) in all eyes completing the study. One patient was lost to follow-up. In all RPS positive eyes with confirmed viral infection by qPCR and CC-IFA clinical symptoms resolved within 72 hours. All eyes completing the study with detectable adenovirus by qPCR demonstrated significant reduction in viral titers by 48-96 hours and the majority demonstrated elimination of infectivity by CC-IFA by 72-96 hours. There were no adverse events in the study. Lead investigator Jesse Pelletier, M.D. commented, “We are excited about this preliminary data and look forward to enrolling patients in a larger controlled clinical study. Currently, there are no drugs approved for the treatment of viral conjunctivitis and it is certainly an area of unmet medical need.”
