Ocuphire Pharma, Inc. Announces Publication of ORION-1 Phase 2 Results for Nyxol in Clinical Ophthalmology
January 20, 2021 at 05:30 pm IST
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Ocuphire Pharma, Inc. announced that results from its ORION-1 Phase 2 clinical trial evaluating the safety and efficacy of Nyxol® in glaucoma and presbyopia have been published in Clinical Ophthalmology, an international, peer-reviewed, open access journal covering all subspecialties within ophthalmology. The paper, titled Phentolamine Mesylate Ophthalmic Solution Provides Lasting Pupil Modulation and Improves Near Visual Acuity in Glaucoma Patients in a Randomized Phase 2b Clinical Trial, reported the following key findings: Use of Nyxol eye drops produced a statistically significant 20% mean reduction or approximately 1 mm in pupil diameter under daytime and nighttime lighting conditions that was sustained for over 30 hours post-dosing; Over 60% of patients in the Nyxol treatment group demonstrated a statistically significant improvement of 1-line or greater in near visual acuity compared to 20% on placebo; There was no statistical difference in eye redness compared to placebo upon examination the following morning after dosing the prior evening before bedtime; and Nyxol eye drops demonstrated with daily evening dosing for 2 weeks a tolerable profile with no systemic effects and an intraocular pressure (IOP) lowering trend, especially for those with IOP baselines that were slightly higher than the normal range. The ORION-1 Phase 2 trial together with the MIRA-1 Phase 2 trial established Ocuphire’s strategy to focus on acute and chronic pupil modulation indications: night vision disturbances (NVD), reversal of mydriasis, and presbyopia. The observation from the trial of durable moderate miotic effects combined with many presbyopia patients experiencing a 1-line improvement in near visual acuity confirmed the potential overall benefits of a smaller pupil aperture for improvement in everyday vision. The results also reaffirmed the potential for Nyxol, a moderate miotic, to be combined with another moderate miotic with the goal to achieve “pinhole” diameter of 1.6 mm to 2.0 mm. This target diameter has been demonstrated by ophthalmic devices and pharmacological treatments to achieve the primary endpoint of 3-line near vision improvement in many patients. Accordingly, Ocuphire is planning to initiate VEGA-1, a Phase 2 randomized, double-masked, placebo-controlled trial investigating a combination of 1% Nyxol and low dose (0.4%) pilocarpine to treat presbyopia. Ocuphire believes that the addition of low-dose pilocarpine, a miotic that works through a different iris muscle and mechanism than Nyxol, may synergistically produce the “pinhole” effect on the pupil as well as reduce the side effects common with higher approved doses of pilocarpine.
Ocuphire Pharma, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders. The Companyâs lead retinal product candidate, APX3330, is a small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein). Ref1 is a regulator of transcription factors such as HIF-1α and NF-B. The Inhibiting REF-1 reduces levels of vascular endothelial growth factor (VEGF) and inflammatory cytokines which are known to play key roles in ocular angiogenesis and inflammation. APX3330 is an oral tablet to be administered twice per day for the treatment of DR. The Companyâs pipeline candidates include APX2009 and APX2014. The Company is initially pursuing APX3330 for the DR indication as first-line therapy and may explore opportunities for clinical benefit as monotherapy or adjunctive therapy for other retinal indications such as DME, wAMD, and GA.