Invirsa has completed patient enrolment in a Phase I/IIa study of its topically administered eyedrop formulation, INV-102, for moderate dry eye.
The primary objective of the study is to determine the safety and preliminary efficacy endpoints of INV-102 in both the Phase I and Phase II portions of the study.
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The Phase I multiple ascending dose portion has 36 patients while the Phase II expansion cohort includes 48 patients.
Patients from both the studies were randomised into a 2:1 ratio to receive INV-102 or a vehicle control for two weeks, with a one-week post-treatment follow-up visit. Dosing was found to be well tolerated in all groups.
Top line data from the trial is anticipated by the third quarter of this year.
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Invirsa CEO Dr Robert Shalwitz said: “Coupled with the strong safety and tolerability profile, the Phase I portion of the study hit sufficient milestones in reducing both signs and symptoms of dry eye in order to proceed to the Phase II portion of the study.
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By GlobalData“The completion of enrollment for the Phase II dry eye subjects is exciting for INV-102 as a completely novel approach to treating the surface of the eye.”
Basis on approval from the Thailand Food and Drug Administration (FDA), Invirsa is also set to proceed with testing INV-102 in treating a second condition of acute infectious keratoconjunctivitis (AIK).
The AIK study intends to enrol patients with either bacterial or viral infections. Invirsa has selected Bangkok as a study location for AIK as it is densely populated and has large numbers of AIK subjects.
The Phase II AIK study will enrol nearly 100 subjects and is expected to commence in the second quarter of this year.
Invirsa clinical development vice-president Dr Charlotte Hartman said: “Our team has been fortunate to work with Iuvo on the Dry Eye Study here in the US, and Grand Pacific CRO on the AIK trial in Thailand.
“We are pleased to be working with both organisations, as they have added tremendous expertise in order to quickly complete one study and to shortly launch another.”
