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Upcoming pharmaceutical treatments for presbyopia may prevent, delay surgery
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WAIKOLOA, Hawaii — PRX100 developed by Presbyopia Therapies could be the first pharmaceutical approach for presbyopic near vision correction and may be the first new treatment to go through the FDA for presbyopia correction, according to Richard L. Lindstrom, MD, at Hawaiian Eye 2019.
PRX 100 contains aceclidine and a low dose tropicamide, Lindstrom said.
Presbyopia Therapies have determined and targeted the ideal pupil size of 1.5 mm to 1.8 mm for reduced glare and improved nighttime driving vision.
“At about 1.8 mm you start to get some negative effects of refraction,” Lindstrom added.
The drop is once-daily for both eyes or in the non-dominant eye.
It improves the quality of near visual acuity for multiple hours past dose.
The onset of action is fast, reversible, non-invasive and well tolerated, he said.
The phase 2b clinical trial is in its final stages and phase 3 is anticipated to start soon, Lindstrom said.
This treatment may delay or prevent the need for glasses, contact lenses or surgical intervention.
“They showed nice improvement in VA, both at two and three lines,” he said. “They might be the leading company right now [for new presbyopia therapies].”
EV06 from Novartis is a prodrug with lipoic acid, which has a good safety record, Lindstrom said.
“Basically it does the opposite of cross-linking,” he said. “It uncross-links collagen and makes the lens more malleable.”
Its phase 1 and 2 compared day 8, 15, 31, 61 and 91 btwn EV06 and placebo.
EV06 was deemed clinically significant as early as day 8, he said.
At day 31, over 30% of subjects showed a gain in bilateral near vision of 10 letters or more and at day 61, it was nearly 50% of subjects, respectively.
“It’s goal is to restore natural accommodation,” Lindstrom said.
CSF-1 (Orasis Pharmaceuticals) is a unique drop featuring a miotic and NSAID in a drug combination ophthalmic solution, to eliminate the need for reading glasses.
It reduces the pupil and increases the depth of field.
CSF-1 showed a statistically and meaningful improvement at 2-lines in a comprehensive phase 2 study.
“Reassuringly, it doesn’t seem to impact driving at night,” he said. – by Abigail Sutton
Reference: Lindstrom RL. Update on the pharmacologic treatment of presbyopia. Presented at: Hawaiian Eye; Jan. 19-25, 2019; Waikoloa, Hawaii.
Disclosures: Lindstrom reports being a consultant to Novartis and Orasis.