Breakthrough Eye Drop for Dry Eye Disease Achieves Positive Phase 3 Results; Hengrui Medicine Holds Exclusive Rights in China

Recently, Novaliq announced positive results from the second pivotal Phase 3 clinical trial of its investigational topical anti-inflammatory eye drop CyclASol for the treatment of dry eye disease (DED). The trial results showed that by Day 29, patients treated with CyclASol experienced significantly greater symptom improvement compared to the control group, with a higher responder rate, and the drug was observed to take effect within two weeks. Novaliq plans to discuss the latest trial results and the next steps for submitting a New Drug Application (NDA) with the U.S. FDA. At the end of 2019, Hengrui Medicine reached an agreement to obtain exclusive rights for the clinical development, manufacturing, and market sales of CyclASol in China.

Dry eye disease is one of the most common chronic ocular conditions, affecting millions of people’s quality of life, and can cause persistent stinging, burning sensation, light sensitivity, blurred vision, and eye fatigue. Damage to the tear film is one of the main reasons for the occurrence of dry eye disease. Currently, the primary treatment for dry eye disease is the use of artificial tears, but most patients do not achieve satisfactory treatment outcomes.

Developed based on Novaliq's proprietary water-free drug delivery EyeSol technology platform, CyclASol is an immunomodulator with local anti-inflammatory effects, containing a 0.1% cyclosporine A formulation. This eye drop delivers the drug using a novel semi-fluorinated alkane carrier, without the use of water, oil, surface lubricants, or preservatives, thereby offering improved solubility, stability, bioavailability, safety, and comfort.

This randomized, double-blind, placebo-controlled, multicenter pivotal Phase 3 clinical trial was conducted in 328 patients with dry eye disease who did not respond to artificial tear treatment. The trial demonstrated superior improvement at the primary sign endpoint compared to the control group, with a greater change from baseline in total corneal fluorescein staining score (tCFS) in the CyclASol group on Day 29 (p=0.0278). The majority of patients treated with CyclASol (71.6%) responded within four weeks, showing clinically meaningful improvements (≥3 grades) in total corneal staining, with a significantly higher response rate compared to the control group (p=0.0002).

In terms of safety, the number of all adverse events (AE) in the trial was low, generally mild. At the end of the 4-week trial, more than 75% of patients reported positive or neutral satisfaction with CyclASol treatment.

References:

[1] Novaliq Announces Positive Topline Results for Second Phase 3 Trial (Essence-2) of CyclASol® in Dry Eye Disease. Retrieved December 21, 2021, from https://www.novaliq.com/press-releases/2021/12/21/novaliq-announces-positive-topline-results-for-second-phase-3-trial-essence-2-of-cyclasol-in-dry-eye-disease/

[2] Sheppard, J. D., et, al. (2021). A Water-free 0.1% Cyclosporine A Solution for Treatment of Dry Eye Disease. Cornea, Publish Ahead of Print. https://doi.org/10.1097/ico.0000000000002633

(Original text has been abridged)

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