AG-80308 aqueous solution eye drop is used for the treatment of Dry Eye Disease. Credit: Orawan Pattarawimonchai / Shutterstock.

Allgenesis Biotherapeutics has unveiled encouraging data from its Phase Ib clinical trial of AG-80308 aqueous solution eye drop to treat dry eye disease (DED).

The double-masked, multi-centre study has assessed the tolerability, safety, and dose response of two formulations of AG-80308 in 84 patients with DED.

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Formulation A including 0.001%, 0.03%, or 0.1% and formulation B with 0.03% were given two times a day for three months.

AG-80308, a formyl peptide receptor (FPR) agonist, showed improvements in tear production, conjunctival staining, and corneal staining responders.

Symptomatic improvements were also observed in the seven-item visual analogue scale, including photophobia, foreign body sensation, pain, itching, eye dryness, burning/stinging, and dry eye discomfort.

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Among all the formulations, 0.001% of formulation A and 0.03% of formulation B provided the best efficacy profile, tolerability, and overall safety.

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Allgenesis Biotherapeutics CEO Dr Madhu Cherukury said: “We are very encouraged with our data showing that patients are seeing improvements in multiple signs and symptoms from the Phase Ib trial as early as two weeks.

“AG-80308 can offer dry eye patients an effective treatment that can be used long-term without the AEs associated with other therapies.”

The company is planning to commence a Phase II trial of AG-80308 in the first quarter of next year.

Allgenesis Biotherapeutics chief medical officer Dr Sunil Patel said: “With the positive results from the Phase Ib trial, we are looking forward to moving this programme into Phase II, where we will evaluate two doses of AG-80308 in formulation B against the vehicle. 

“This will be an ideal drug for treating chronic dry eye patients due to its unique MOA and excellent potency.”