Novaliq’s mission is to “transform ocular therapeutics” using a proprietary water-free platform to accomplish the goal. A key limitation of water-based technologies is bioavailability, which EyeSol and CyclASol overcome with smaller drop size, better bioavailability, and enabling lipophilic drugs. The company has put its platform to good use, with “one of the richest pipelines in dry eye therapy.”
Because the bioavailability is better with EyeSol than other formulations, there is no need for preservatives in the drop, Dr. Roesky noted. Clinical studies are showing that translates into higher efficacy and tolerability. NovaTears is undergoing commercial rollout, NovaTears Omega-3 is expected to launch in Europe in 2018, and CyclASol is expected to have a Phase IIb/III readout in 2018 with a launch target date of 2021.
CyclASol has a much lower rate of instillation site irritation than other dry eye drugs, 2% compared with 10% or more with Restasis and Xiidra), and onset of action is within one month (compared with three for Xiidra and six for Restasis). Novaliq’s pivotal ESSENCE trial (n=158) is expected to have topline data in 2018, and the study will target a 12-week endpoint in improvement of the signs and symptoms of dry eye; primary efficacy endpoint will be at week 4. NovaTears is “the first dry eye drug to address meibomian gland dysfunction and evaporative-caused dry eye disease,” remarked Dr. Roesky. NOV03 is entering Phase II studies in the US in both once- and twice-daily formulations (n=100 in each arm). Topline data from that study is expected around September 2018. The platform technology is not limited to dry eye, and Novaliq is in early-stage development in glaucoma and retina diseases.