Lacripep is currently in a phase 2 trial to compare its efficacy versus placebo in patients with Sjogren’s syndrome dry eye (ClinicalTrials.gov Identifier: NCT03226444). The primary endpoint is change in fluorescein corneal staining score at week four from baseline.
Secondary endpoints include changes in eye dryness, mean SANDE 2 scores, and individual symptom assessments, among others.
Mitotech is developing a few drug formulations of SkQ1, such as Visomitin, which is currently in phase 3 trials for the treatment of DED (ClinicalTrials.gov Identifier: NCT03764735).
Visomitin is already approved for this indication in Russia. Clinical trials have shown that Visomitin is efficacious in improving corneal and conjunctival staining, tear quality, and other DED symptoms.
According to the company website, one part of SkQ1 functions as a molecular “tow truck,” carrying the other part of the molecule — an extremely active antioxidant plastoquinone — into mitochondria.
The molecule was designed to act as a mitochondria-targeted ROS scavenger in general and as a very efficient cardiolipin peroxidation inhibitor, in particular. Mitotech is also developing SkQ1 as a potential treatment for uveitis and dry age-related macular degeneration.
Novaliq has two DED products in the pipeline: NOVO3 (100% perfluorohexyloctane) and CyclASol (ophthalmic solution of 0.1% cyclosporine A in EyeSol). NOVO3 is being developed for evaporative DED from meibomian gland dysfunction. The SEECASE-1 U.S. study, enrolled 336 patients, and the SEECASE-2 study, which is beginning this year. CyclASol is in development for the treatment of aqueous deficient DED. The ESSENCE-1 U.S. study enrolled 328 patients; the ESSENCE-2 study is beginning this year. New Drug Application submissions for both drugs are expected in 2021.
Oyster Point Pharma has two nasal spray therapeutics in clinical trial development for the treatment of DED. OC-01 (ClinicalTrials.gov Identifier: NCT03873246) and OC-02 are selective nicotinic acetylcholine receptor (nAChR) agonists that harness the trigeminal parasympathetic pathway to improve tear film production.
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