Positive topline results from the phase III pivotal study, BRIO-II, evaluating BRIMOCHOL™ PF, a preservative-free ophthalmic solution for the treatment of presbyopia, have been announced by biotech company Tenpoint Therapeutics.1 Presbyopia results in the gradual loss of the eye’s ability to focus on nearby objects with age, a condition that affects around 2 billion individuals globally.2 BRIMOCHOL™ PF is a fixed-dose combination of carbachol and brimonidine tartrate, developed to improve near visual acuity while maintaining distance vision. The Phase 3 BRIO-II trial aimed to assess the safety, efficacy, and tolerability of this novel therapeutic.
The multicenter, randomized, double masked, BRIO-II study (NCT05135286) met its primary endpoint, demonstrating statistically significant improvements in near vision versus vehicle at all timepoints out to 8 hours (p<0.008). It also showed clinically and statistically significant reductions in pupil size at all timepoints. BRIMOCHOL™ PF was well-tolerated over a 12-month daily dosing period, with no treatment-related serious adverse events. Additional analyses revealed that BRIMOCHOL™ PF significantly improved reading speed and patient-reported quality of life outcomes, as measured by the NEI-Refractive Error Quality of Life questionnaire.
Following the positive results from BRIO-II, Tenpoint Therapeutics plans to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in the coming months. Further information will be presented at upcoming scientific meetings.
With the potential to be the first preservative-free ophthalmic treatment for presbyopia, the ophthalmology community eagerly anticipates further updates.
References:
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Tenpoint Therapeutics Announces Positive Topline Data from Phase 3 Pivotal Study, BRIO-II, of BRIMOCHOLTM PF for the Treatment of Presbyopia. Tenpoint Therapurics websiste. Available at: https://cdn.prod.website-files.com/64b01a75c3f993c7c15191dd/677ff7ffefa72f00cca150c7_PR%20Tenpoint%20Announces%20Positive%20Topline%20Clinical%20Data_8Jan2025_1pm.pdf (accessed 10 January 2025).
- Wolffsohn JS, Davies LN, Sheppard AL. New insights in presbyopia: impact of correction strategies. BMJ Open Ophthalmol. 2023;8:e001122. doi: 10.1136/bmjophth-2022-001122
Disclosures: This article was created by the touchOPHTHALMOLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
