Dompé Farmaceutici S.p.A and Dompé U.S. announced that the first patient has been enrolled in NGF0118, a multicenter, randomized, double-masked, vehicle-controlled, parallel group study to evaluate the safety and efficacy of rhNGF eye solution vs. vehicle in patients with moderate to severe dry eye disease (DED).
The study will analyze approximately 300 patients at 11 different sites in the United States for a period beginning with 4 weeks of active treatment followed by 12 weeks of observation. In a separate clinical study, the company plans to collect a variety of biomarker information from DED patients as part of an initiative to develop tailored treatments.
“The effects of currently available treatments for chronic dry eye disease mostly address only inflammation and wear off soon after discontinuing therapy. Our researchers have decades of understanding of the mechanism of action of nerve growth factor, and this knowledge gives us hope that a new therapy, which includes rhNGF, could produce a more durable treatment effect. Our aim is to potentially free some patients from the burden of continuous treatment,” Flavio Mantelli, MD, PhD, a cornea specialist and Chief Medical Officer of Dompé, said in a company news release.
“We are pleased to be part of the team involved in the NGF0118 Dry Eye Disease study,” said Dr. Melissa Toyos, MD, Partner and Research Director at the Toyos Clinic and an investigator in the trial. “Dry eye can be challenging to diagnose and manage because it is multifactorial, and the signs and symptoms vary considerably from patient to patient. We are excited to be partnering with Dompé to explore a treatment that may address the underlying tear production deficiency and the neuro-sensory abnormalities, which could result in a disease modifying therapy.”
This study will enroll eligible adult patients with moderate to severe DED, which is diagnosed through a variety of tests related to ocular surface health, objective measures of dryness, and patient reported ocular comfort.
The primary endpoint for the current study is the change from baseline in ocular surface tear wetting measured via Schirmer I test. Key secondary endpoints include signs and symptoms of DED, including ocular surface staining, which is an objective measure of ocular surface integrity and health.
The study design was informed by a phase 2a, prospective open label, multiple-dose, efficacy and safety study of rhNGF eye drops in a cohort of patients with DED. The study was supported by the company and was conducted at the General Hospital of Vienna (Austria), and the results were recently published in the British Journal of Ophthalmology (BJO).
For additional information about the NGF0118 study and to learn more about eligibility, find more information at ClinialTrials.gov on the study page (NCT03982368).