Trial’s controlled design was expected to quantify the original contribution of stem cells in the IMP. Credit: Petr Novák/Wikipedia.

Wize Pharma has completed patient enrolment in a Phase II clinical trial evaluating the efficacy and safety of LO2A in comparison with placebo to treat patients with moderate to severe Conjunctivochalasis (CCH).

The randomised, placebo-controlled trial includes 62 patients in Israel.

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In the trial, participants will be randomly assigned in a 1:1 ratio to one of two treatment groups, including LO2A or placebo. They will be treated with the LO2A eye drops for three months.

The trial’s primary endpoint is change from baseline in lissamine green conjunctival staining (LGCS) score, which is a standard measurement tool for the indication, after three months of treatment.

“We believe this data may support our clinical development path for LO2A in the US market.”

Its secondary endpoints comprise change in the lid-parallel conjunctival fold (LIPCOF) grade score at one and three months compared to baseline, and change from baseline in LGCS score at one month.

Change in tear-film break up time (TFBUT) and in ocular surface disease index (OSDI) score compared to baseline at one and three months are also included as secondary endpoints.

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Wize Pharma chairman Ron Mayron said: “This Phase II study, while conducted in Israel, is designed according to US standards by a leading US full-service ophthalmic clinical research organisation and product development firm. As such, we believe this data may support our clinical development path for LO2A in the US market.

“Data from a prior study in Hungary, conducted by the inventor of LO2A, demonstrated improvement in CCH measures following treatment with LO2A.

“These patients had previously tried and failed treatment on a variety of artificial tear preparations. LO2A is already approved in Hungary for patients with CCH.”

Wize Pharma has developed the LO2A drug for the treatment of dry eye syndrome (DES), and other ophthalmological illnesses, including CCH and Sjögren’s syndrome.

The drug is currently approved in Israel for DES treatment and its sales are expected to begin in Israel within this year.