New presbyopia drop’s pH contributes to efficacy
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BOSTON – The pH of the recently approved Vuity from Allergan, an Abbvie company, improves the drug’s availability and translates to faster pupil size reduction, according to a presentation here at the American Academy of Optometry annual meeting.
Michael R. Robinson, MD, vice president, global therapeutic area head, eye care, AbbVie, spoke at an academy-sponsored press conference about the FDA-approved treatment for presbyopia. He said the company’s phase 2 trials for Vuity (pilocarpine HCl ophthalmic solution 1.25%) evaluated “16 different formulations to find a drop that, when it hits the ocular surface, adjusts to a pH of about 7 to improve bioavailability.”
Robinson noted that all pilocarpine formulations are stored at a low pH – about 4 – to maintain stability, but it leads to low bioavailability and “barely crosses the cornea.”
“We developed an in vitro model to assess the speed at which our formulation allows the pH to equilibrate to physiologic pH within 1 minute,” he added.
The company stated in a press release that the primary mechanism of action is through pupil constriction to improve near and intermediate vision while maintaining some pupillary response to different lighting conditions – an effect known as dynamic pupil modulation. The optimized formulation of Vuity, which was called AGN-190584 when it was under investigation, uses pHast technology.
The company also said that academy presentations covered clinical results for near and intermediate vision, functional near vision, efficacy for post-LASIK patients and the patient experience.
Robinson noted at the press conference that two phase 3 studies, GEMINI 1 and GEMINI, both met primary end points.
The primary end point was achieving statistical significance compared to vehicle in improvement in mesopic near vision on day 30, hour 3, without compromising distance vision, the company said in the release.
Most secondary endpoints were also met in both studies, including a significant improvement vs. vehicle in patient-reported outcomes, such as an increase in vision-related reading ability, and reductions in the impact of presbyopia on daily life and use of coping behaviors to manage presbyopia, according to the release.