Ocular Pain Treatment Shows Promise in Phase 2 Trial
Experimental drug shows promise in treatment of pain and dry eye.
Positive results were found from a pair of phase 2 clinical trials that tested SYL1001 for the treatment of patients with ocular pain relating to dry eye syndrome.
The randomized, parallel group, double-masked, and placebo controlled phase 2 trials were conducted in 8 centers in Spain and Estonia, with 127 patients who suffered from ocular discomfort related to dry eye syndrome.
The 4 doses of SYL1001 (0.375%, 0.75%, 1.125% and 2.25%) came in the form of eye drops and were tested for safety and efficacy against a placebo following 10 days of daily administration.
The results of the study showed that the 1.125% dose of SYL1001 achieved the best primary and secondary endpoints, which reduced both ocular pain and conjunctival hyperaemia.
“These positive results support continuing clinical development of SYL1001,” said COO of Sylentis, Ana Isabel Jiménez. “Sylentis is currently designing the Phase 3 clinical program which will be validated with the relevant regulatory authorities.”
The 2 trials were also able to confirm a favorable safety and tolerance profile of SYL1001, and showed no difference in the percentage of adverse events between the placebo group and the SYL1001 group.