Novaliq recently announced its agreement with the US Food and Drug Administration (FDA) regarding the second registrational trial ESSENCE-2 for its late-stage therapy, CyclASol, for dry eye syndrome (DES). This is a positive development for the DES market, particularly due to its favorable tolerability profile, according to GlobalData, a leading data and analytics company.

ESSENCE-2 will be a multicenter, randomized, double-blind clinical trial to test the efficacy, safety, and tolerability of CyclASol for treatment of signs and symptoms of DES. Results from its earlier pivotal Phase IIB/III trial, ESSENCE-1, demonstrated an early onset of action and a favorable tolerability profile versus vehicle. If similar results are produced from ESSENCE-2 trial, then it will likely lead to ophthalmologists preferring CyclASol over other cyclosporine formulations.

Vinie Varkey, M.Sc, Senior Ophthalmology Analyst at GlobalData, comments: “One of the unmet needs in DES is for a therapy option with favorable tolerability profile compared to currently available treatment options. The hydrophobic nature of currently available cyclosporine formulations can limit the use of aqueous ophthalmic vehicles. Oil-based emulsions can contribute to poor tolerance, as well as low bioavailability on the ocular surface due to a short retention time, all of which can reduce treatment efficacy.

“Although therapies with novel MOAs are welcome and encouraging, key opinion leaders interviewed by GlobalData have also indicated that if therapies with well-established mechanisms of action in DES are able to demonstrate a more favorable tolerability and efficacy profile, then that would also help to address the aforementioned unmet need. This is where CyclASol could potentially help to fill the gap that is otherwise partially served by currently available cyclosporine formulations.”