10.29.19

Eyenovia Advances MicroLine for the Treatment of Presbyopia; Reprioritizes Late-Stage Ophthalmology Pipeline

Source: Eyenovia

Eyenovia announced that the company is advancing the development of its MicroLine program for the improvement in near vision in patients with presbyopia toward phase 3 development. As a result of prioritizing MicroLine in tandem with its MicroPine (progressive myopia) and MicroStat (mydriasis) programs, the company is deferring development activities for its MicroProst (glaucoma and ocular hypertension) and MicroTears (red eye and itch relief/lubrication) programs.

“The MicroLine program, based on our proprietary piezo-formulation of the well-known drug pilocarpine, could potentially be one of the first pharmacologic treatment options for presbyopia. Combined with our novel platform technology, we believe that Eyenovia can provide people interested in enhancing their lifestyle with pharmacotherapy similar to other aesthetic-focused products. MicroLine is designed to replace reading glasses for approximately 3-4 hours, while addressing the tolerability and instillation issues associated with traditional eye drop approaches,” Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer, said in a company news release. “We anticipate initiating and completing the phase 3 VISION trials for MicroLine in 2020.”

“After conducting a strategic review of Eyenovia’s pipeline with the goal of maximizing the value of its portfolio, we believe that MicroLine, MicroPine, and MicroStat represent the highest value opportunities for Eyenovia, with potential product launches from 2022 to 2024,” Dr. Fred Eshelman, Eyenovia’s Chairman of the Board, said in the news release. “We believe these three programs focus on areas with significant unmet needs or where the patient experience could be greatly improved. MicroLine, in particular, represents an exciting part of our pipeline, potentially enabling millions of people in the United States to forgo their reading glasses for approximately 3-4 hours of improved vision.”

The company expects the reprioritization of its programs to yield overall cost savings to Eyenovia of approximately $1.5 to $1.9 million in 2020.

Program Indication 2020 Milestones Estimated U.S. Market Opportunity
MicroLine Presbyopia Initiate and Complete Phase III VISION Study $2B+
MicroPine Progressive
Myopia
Complete Phase III CHAPERONE Enrollment $5B+
MicroStat Mydriasis File NDA $300M+

 

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