Phase 2B clinical trials of CSF-1 for presbyopia have met primary and secondary endpoints

CSF-1 (pilocarpine hydrochloride 0.4%, Orasis Pharmaceuticals) ophthalmic solution, an eye drop candidate for presbyopia, met primary safety and efficacy endpoints in the first of 2 studies in phase 2b, and Marjan Farid, MD, ABO, discussed the results during a presentation at the 2022 American Society of Cataract and Refractive Surgery Annual Meeting in Washington, D.C.

Farid is Clinical Professor of Ophthalmology and Program Director of Cornea, Cataract, and Refractive Surgery, Ocular Surface Diseases Program, University of California San Diego School of Medicine.

In the first trial, results showed that 47% of participants treated with CSF-1 achieved an increase of 3 lines or more in distance-corrected near visual acuity (DCNAV) 1 hour after instillation of gout on day 15. vs. 16% reaching this level in the vehicle group. This difference reached significance (p = 0.0002).

The secondary endpoint was also met, 80% of participants treated with CSF-1 achieved an increase of 2 or more lines in DCNVA, compared to 43% in the vehicle group; this difference also reached significance (p = 0.0001).

In addition, distance or night vision did not decrease following treatment with CSF-1.

Farid pointed out that the safety profile showed the drug was well tolerated. The most common adverse events reported by more than 5% of participants were pain on instillation in 5.5%, headache in 9.1% and visual blurring in 10.9%. All episodes were considered mild, transient, and resolved without treatment.

In addition to the primary endpoint, Farid added that “meeting the secondary endpoint of a gain of 2 or more lines is important, especially for early presbyopes, whose vision may not be not yet altered enough to achieve wins of more than 3 lines.

Investigators were also encouraged that distance and night vision were not negatively affected.

Post-hoc analysis

Preeya K. Gupta, MD, in private practice in Cary, NC, reported the results of the second study, a post-hoc evaluation of the primary endpoint of durable improvement with CSF-1 treatment.

The analysis showed that after 1 dose of CSF-1, 47% of binocularly treated participants had a consistent improvement in VA level of 20/40 or better over an 8-hour period on day 15. , in participants treated with both monocular and binocular routes, the percentage of sustained improvements in DCNVA was greater in those treated with CSF-1 compared to vehicle treatment in those assessed for sustained vision of 20 /40 at all time points (p

“These results, which showed that a greater proportion of participants receiving CSF-1 achieved sustained functional near vision of 20/40 or better versus vehicle in a binocular test, demonstrate a clinically meaningful improvement. that would make it easier for people treated with CSF-1 to carry out daily activities that require near vision,” Gupta said.

Gupta added that binocular summation, which is the superiority of binocular performance over monocular performance, is implicated in improving visual acuity.

“Achieving binocular summation is an important marker for evaluating the effectiveness of potential treatments for this age-related condition,” Gupta concluded. “In this study, the proportion of participants who achieved sustained functional near vision, a distance-corrected near visual acuity of 20/40 or better, was higher in binocular-treated patients than in monocular-treated patients, showing the potential of CSF-1 to help patients achieve binocular summation and ultimately improve functional near vision.

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