A phase 3 clinical trial of Eyenovia’s MicroLine in patients with age-related long-sightedness has hit its primary endpoint. The formulation has the same active ingredient, pilocarpine, as a near-approval Allergan drug but is administered via a dispenser designed to improve on conventional eyedroppers.
Pilocarpine is a muscarinic cholinergic agonist that is already used to reduce pressure inside the eye. In recent years, Allergan, Eyenovia and a clutch of other companies have worked to show pilocarpine and other miotic agents can counter the long-sightedness that develops in people after the age of 40. The condition, known as presbyopia, is typically corrected using reading glasses.
New York-based Eyenovia took a step toward establishing MicroLine as an alternative treatment this week when it reported top-line results from its VISION-1 study. The phase 3 clinical trial randomized 84 patients to receive one of two doses of pilocarpine or placebo.
Eyenovia linked MicroLine to a statistically significant improvement over placebo in the proportion of patients who experienced a three-line or greater improvement on a vision test in low light conditions two hours after treatment. The company is yet to share further efficacy information. On the safety front, Eyenovia said MicroLine was very well tolerated, causing only mild adverse events.
Buoyed by the findings, Eyenovia outlined plans to run a second phase 3 registration study. The plan is to use data from the two clinical trials to support an application for approval to the FDA.
Eyenovia is likely to face competition for the market. AbbVie’s Allergan filed for FDA approval of its pilocarpine ophthalmic solution in presbyopia in February on the strength of a phase 3 program that enrolled 750 patients. The two Allergan trials assessed the change in vision after 30 days of daily dosing with its pilocarpine eye drops.
Allergan looks set to get to market before Eyenovia and is a bigger organization. Eyenovia is looking to its Optejet dispenser as a source of differentiation, pointing to evidence that it delivers more consistent doses than typical eyedroppers.