Further study planned based on positive results for presbyopia drug
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Novartis plans further clinical development of UNR844, a topical ophthalmic solution for treating presbyopia, based on results of phase 1 and 2 studies, according to a presenter here at the American Academy of Optometry virtual meeting.
Kathryn Richdale, OD, PhD, FAAO, said during an academy-sponsored press conference that an increase in the stiffness of the ocular lens, which causes presbyopia in conjunction with a weakening of the ciliary muscle, is though to be due to an increase in disulfide content.
“UNR844 is an ester of naturally occurring R-lipoic acid and choline,” she said. “UNR844 penetrates the cornea, where it is metabolized into choline and R-lipoic acid. Enzymes within the lens break down the lipoic acid to the active form, DHLA [dihydrolipoic acid], and it’s the DHLA that’s thought to reduce the disulfide bonds, thus allowing a restoration of elasticity in the lens.”
UNR844 has been previously studied in phase 1 and 2 trials, she said, where 88% of the subjects randomized to UNR844 had improvement of at least one line of uncorrected visual acuity.
“Novartis purchased the drug and conducted its own phase 2a trial,” Richdale said.
Seventy-six subjects 45 to 65 years old with presbyopia completed the study. According to the study abstract, they received either 1.5% UNR844 as a chloride salt or placebo drops in each eye, twice a day for 3 months. Researchers saw a four-letter median difference between the two groups (p = .0924), with no meaningful differences in side effects.
The researchers stated in the study abstract that based on these results as well as the previous phase 1/2 results, a phase 2b dose-finding study is planned.
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Richdale K, et al. UNR844 ophthalmic solution for the topical treatment of presbyopia: Results of a phase 2 randomized controlled trial. Presented at: American Academy of Optometry meeting; October 7-22, 2020; virtual meeting.
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