Ocuphire Pharma
Ocuphire Pharma focuses on developing small molecule therapies for retinal and refractive eye disorders, including its lead product APX3330 for diabetic retinopathy and the FDA-approved Phentolamine Ophthalmic Solution 0.75% for mydriasis.
Company Overview
Ocuphire Pharma develops small molecule therapies aimed at treating patients with retinal and refractive eye disorders. The company is active in advancing its product pipeline, which includes multiple product candidates in various stages of clinical development. Their focus is on addressing unmet medical needs in ophthalmology, especially for conditions that impact vision health.
Products and Development
Ocuphire Pharma's lead retinal product candidate, APX3330, is an oral small-molecule inhibitor targeting Ref-1, aimed at treating non-proliferative diabetic retinopathy. The product has undergone extensive evaluation in over 340 patients through six Phase 1 and five Phase 2 trials. The company also focuses on Phentolamine Ophthalmic Solution 0.75%, approved by the FDA for treating pharmacologically-induced mydriasis under the brand name RYZUMVI™ in September 2023. This solution has been evaluated in more than 650 subjects across 12 completed Phase 1, 2, and 3 trials.
Clinical Trials and Research
Ocuphire Pharma has demonstrated progress through numerous clinical evaluations. The company has reported positive results from five clinical trials for its Phentolamine Ophthalmic Solution Eye Drops, including a Phase 3 trial in RM (MIRA-2) and a Phase 2 proof-of-concept trial in Presbyopia (VEGA-1). Additionally, APX3330 has been systematically studied in over 340 patients in Phase 1 and Phase 2 trials, proving its potential in treating non-proliferative diabetic retinopathy.
Strategic Partnerships and Future Prospects
Ocuphire Pharma has established a partnership with Viatris, Inc. to develop and commercialize Phentolamine Ophthalmic Solution 0.75%. The company is also actively exploring opportunities to acquire additional ophthalmic assets and seeks strategic partners for the late-stage development, regulatory preparation, and commercialization of its drugs in key global markets. Ocuphire Pharma's future development plans include investigating second-generation analogs of APX3330, such as APX2009 and APX2014, for use in wet age-related macular degeneration.
Second-Generation Product Candidates
APX2009 and APX2014 are Ocuphire Pharma's second-generation pre-clinical product candidates and analogs of APX3330. These candidates are under investigation for potential use in treating wet age-related macular degeneration. The company's ongoing R&D efforts aim to expand its portfolio and address various ophthalmic conditions to improve patient outcomes.