Phase I/II study showed eye drops improved near-vision acuity

Novartis is buying Texas-based Encore Vision to acquire the latter’s clinical-stage, disease-modifying, topical treatment for presbyopia. No financial details of the agreement have been disclosed.

Encore Vision’s lead product, EV06, is a first-in-class topical therapy for presbyopia, which the firm suggests affects more than 80% of adults over the age of 45 years. EV06 comprises a proprietary small molecule prodrug, which the firm claims works with the eye’s endogenous enzymes to break molecular cross-links that cause stiffness in the lens, and so restore lens flexibility and ability to focus.

During May 2016 Encore reported positive results from a placebo-controlled Phase I/II study evaluating EV06 eyedrops in 75 presbyopic individuals. After 3 months of twice-daily treatment with one drop of EV06, subjects in the EV06 group demonstrated improvements in all distance-corrected near-vision acuity (DCNVA) efficacy measures. By day 91, 82% of EV06-treated patients had achieved 20/40 DCNVA or better, compared with 48% of placebo patients. By day 91, 36% of EV06-treated subjects had gained 10 or more letters, compared to 16% of patients in the placebo group.

“There is a large need for innovative, effective, and safe treatment options for people with presbyopia, and there is currently no disease-modifying treatment available at all,” said Vasant Narasimhan, global head, drug development, and CMO, Novartis. “The addition of this topical disease-modifying treatment to our portfolio, if successful, will provide affected people with a new option to improve and maintain their vision and quality of life.”

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