June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Phentolamine Ophthalmic Solution, with and without Low Dose Pilocarpine, Provides Durable Improvement in Distance Corrected Near Vision in Presbyopic Patients: A Responder Analysis
Author Affiliations & Notes
  • Mitchell G Brigell
    Ocuphire Pharma Inc, Farmington Hills, Michigan, United States
  • Jay Stuart Pepose
    Pepose Vision Institute, Chesterfield, Missouri, United States
    Ocuphire Pharma Inc, Farmington Hills, Michigan, United States
  • Kavon Rahmani
    Ocuphire Pharma Inc, Farmington Hills, Michigan, United States
  • Louis Haddad
    Ocuphire Pharma Inc, Farmington Hills, Michigan, United States
  • Mina Sooch
    Ocuphire Pharma Inc, Farmington Hills, Michigan, United States
  • Footnotes
    Commercial Relationships   Mitchell Brigell Ocuphire Pharma, ONL Therapeutics, Code C (Consultant/Contractor); Jay Pepose Ocuphire Pharma, Code C (Consultant/Contractor), Pepose Vision Institute, Code O (Owner); Kavon Rahmani Ocuphire Pharma, Code C (Consultant/Contractor); Louis Haddad Ocuphire Pharma, Code C (Consultant/Contractor); Mina Sooch Ocuphire Pharma, Code E (Employment), Ocuphire Pharma, Code I (Personal Financial Interest)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 5423. doi:
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      Mitchell G Brigell, Jay Stuart Pepose, Kavon Rahmani, Louis Haddad, Mina Sooch; Phentolamine Ophthalmic Solution, with and without Low Dose Pilocarpine, Provides Durable Improvement in Distance Corrected Near Vision in Presbyopic Patients: A Responder Analysis. Invest. Ophthalmol. Vis. Sci. 2023;64(8):5423.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To evaluate the durability of 0.75% phentolamine ophthalmic solution (POS) and the added value of 0.4% low dose pilocarpine (LDP) for improvingdistance corrected near visual acuity (DCNVA) in presbyopic patients.

Methods : In the VEGA-1 multicenter, randomized, placebo-controlled, double-masked clinical trial, subjects with DCNVA of 20/50 or worse were randomized to 0.75% POS or placebo (evening dosing), with or without a dose of LDP the morning after the 3rd or 4th dose of POS. At 12, 13, and 18 hrs after the last dose of POS, the percent of patients with improvement of ≥ 3 lines binocular photopic DCNVA relative to baseline was compared between treatment groups using logistic regression.

Results : Of 150 subjects, (mean age 53 years, 72% female), 43 were randomized to placebo alone, 30 to POS alone, 43 to POS+LDP, and 31 to LDP alone. At 0 hours, prior to LDP dosing 39/73 (53%) and 20/73 (27%) patients who received POS gained ≥2 and ≥3 lines of DCNVA, respectively. In the POS group, 14/15 patients who gained ≥2 lines at 12 hrs maintained their response at 13 hrs, and 13/15 (87%) maintained this response through 18 hrs. Using a ≥3 line criterion, 5/8 were POS responders at 13 hrs and 7/8 met this criterion at 18 hrs. In the POS + LDP group, 23/24 patients who gained ≥2 lines at 12 hrs maintained their response at 13 hrs and 11 more patients were responders with the addition of LDP. Using a ≥3 line criterion, 13/14 patients were responders at 13 hrs and 13 more patients were responders with the addition of LDP. At 18 hrs post-POS dose (6 hrs post-LDP dose), the added benefit of LDP waned with 9 (vs. 11) more patients gaining ≥2 lines and 6 (vs. 13) more patients gaining ≥3 lines of DCNVA.

Conclusions : In this Phase 2 presbyopia trial, POS demonstrated a sustained durable response as 53% of subjects gained 2 or more lines of DCNVA and 87% of responders maintained their response through 18 hours. The addition of LDP increased the percent of patients who gained ≥2 line gain 1 hour after dosing by 48% (11/23) and the number of patients who gained ≥3 lines by 100% (13/13).

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

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