First Patient Enrolled in LYNX-2 Phase 3 Study Evaluating Phentolamine Ophthalmic Solution 0.75% (PS) for the Treatment of Decreased Visual Acuity Under Low Light Conditions Following Keratorefractive Surgery - Seite 3

LYNX-2 Design

LYNX-2 is a randomized, double-masked, placebo-controlled Phase 3 registration study designed to evaluate the safety and efficacy of PS compared to placebo in subjects who underwent keratorefractive surgery and then reported decreased visual acuity under low light conditions. The trial is expected to enroll 200 subjects. The primary endpoint, agreed with the FDA under the SPA, will be a gain of 3 lines (or 15 letters) or more of distance vision improvement on a low contrast chart in low light conditions after 15 days of dosing. Additional information about the Phase 3 trial can be found at www.clinicaltrials.gov.

About Ocuphire Pharma

Ocuphire is a clinical-stage ophthalmic biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders.

Ocuphire’s lead retinal product candidate, APX3330, is an oral small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein) for the treatment of non-proliferative diabetic retinopathy (NPDR). Ref-1 is a regulator of the transcription factors HIF-1α and NF-κB. 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 diabetic retinopathy (DR). A Phase 2 study in subjects with DR and an End-of-Phase 2 meeting have recently been completed, and a SPA is planned to be submitted.

In addition, Ocuphire has a partnership with Viatris to develop and commercialize Phentolamine Ophthalmic Solution 0.75% (PS), a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size. PS was approved by the FDA for the treatment for pharmacologically-induced mydriasis under the brand name RYZUMVI in September 2023. As discussed above, PS is also in Phase 3 clinical development for the treatment of presbyopia and for the treatment of decreased visual acuity under low light (mesopic) conditions after keratorefractive surgery.

Ocuphire is also developing APX2009 and APX2014, second-generation analogs of APX3330. These programs are being evaluated for treating other retinal diseases such as age-related macular degeneration and geographic atrophy. For more information, please visit www.ocuphire.com. 

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning the applications of PS in ophthalmology, the registration program for PS, the LYNX-2 Phase 3 registration study, the benefits, uses and side effects of PS treatment, ongoing discussions with the FDA regarding various of our drug products, and continued drug development under our agreement with Viatris.