Ocular inflammation compound from SARcode well-tolerated in phase 1 trial

SAN FRANCISCO — A phase 1 trial of SAR 1118 ophthalmic solution has demonstrated the small molecule's safety and tolerability when administered topically up to three times daily at dose strengths of up to 5% in healthy volunteers, according to a press release from SARcode Corporation, the developer of the drug.

The randomized, double-masked, placebo-controlled trial of single- and multiple-escalating doses of SAR 1118 was designed to evaluate the local and systemic safety and pharmacokinetic parameters of the drug in the plasma and tears of 28 healthy adults at four dose strengths: 0.1%, 0.3%, 1%, and 5%. The dosing schedule was divided into three phases in which subjects received a single dose of SAR 1118 twice daily for 10 days and then three times daily for 10 days with a 72-hour wash-out interval between study periods and a 2-week observation period after the completion of dosing.

All subjects completed the trial, and there were no serious or severe ocular or non-ocular adverse events at any dose strength or schedule. In addition, the pharmacokinetic parameters demonstrated adequate ocular exposure at all three dose schedules with minimal systemic exposure, according to the release.

Based on these results, SARcode has selected dose strengths and schedules for its phase 2 programs for treating allergic conjunctivitis and dry eye and expects to release data for these programs later this year.