Ocumension Therapeutics has announced the completion of patient enrollment in its second Phase III clinical trial, known as the Denali trial, for OT-301 (NCX 470). This trial is a significant step in the development of a novel treatment for open-angle glaucoma and ocular hypertension. The Denali trial, conducted across multiple regions including the United States and China, aims to evaluate the safety and efficacy of OT-301 ophthalmic solution in comparison to the current standard of care, latanoprost.
Trial Design and Objectives
The Denali trial is a three-month, multi-regional Phase III clinical trial designed to assess the efficacy of OT-301 (NCX 470) ophthalmic solution, at a concentration of 0.1%, against latanoprost ophthalmic solution, 0.005%. The primary endpoint is the lowering of intraocular pressure (IOP) in patients diagnosed with open-angle glaucoma or ocular hypertension. The trial includes a long-term safety extension to monitor the long-term effects of the treatment.
More than 670 patients have been enrolled across approximately 90 clinical sites in the United States and China. This large sample size is intended to provide robust data on both the efficacy and safety of OT-301.
OT-301: A Novel Approach to IOP Reduction
OT-301 (NCX 470) represents a novel approach to reducing IOP in glaucoma and ocular hypertension patients. It is a first-in-class nitric oxide (NO)-donating prostaglandin analog. Invented by Nicox S.A., OT-301 is designed to release both bimatoprost, a prostaglandin analog already approved by the FDA, and nitric oxide (NO). This dual-action mechanism aims to enhance IOP reduction compared to traditional prostaglandin analogs.
Ocumension Therapeutics holds an exclusive license from Nicox to develop, manufacture, and commercialize OT-301 (NCX 470) in Greater China, Korea, and twelve countries in Southeast Asia. This collaboration allows Ocumension to expand its portfolio of ophthalmological treatments and address the unmet needs in these regions.
Previous Trial Data
The first Phase III clinical trial of NCX 470, the Mont Blanc trial, was initiated by Nicox in the United States in June 2020. The Mont Blanc trial utilized an adaptive design, ultimately selecting the 0.1% dose of NCX 470 based on its robust efficacy and safety profile. Topline results from the Mont Blanc trial supported the advancement of the 0.1% dose into further clinical development.
Clinical Significance
Glaucoma is a leading cause of irreversible blindness worldwide, and ocular hypertension is a significant risk factor for developing glaucoma. Effective management of IOP is crucial in preventing disease progression. The current standard of care, prostaglandin analogs like latanoprost, are effective but may not provide sufficient IOP reduction for all patients. OT-301, with its novel mechanism of action, has the potential to offer improved IOP control and benefit patients who do not respond adequately to existing treatments. The results of the Denali trial are eagerly awaited, as they could pave the way for a new treatment option for patients with open-angle glaucoma and ocular hypertension.
