Clinical Trials
15
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1996
Completed
14
93.3%
Withdrawn
1
6.7%
No approval data available
- DelveInsight's latest report identifies 18+ companies developing 20+ therapeutic candidates for open-angle glaucoma, with several treatments advancing through late-stage clinical trials. - Key players including Nicox, Qlaris Bio, and Glaukos Corporation are making significant progress with innovative treatments like NCX 470, QLS-111, and iDose TREX, demonstrating positive clinical outcomes. - Novel drug delivery mechanisms, including sustained-release implants and encapsulated cell therapies, are emerging as promising approaches to address the challenges of treatment adherence and efficacy in glaucoma management.
- New analysis from Mont Blanc Phase 3 trial reveals NCX 470 enabled more patients to achieve target intraocular pressure of ≤18 mmHg compared to standard-of-care latanoprost. - NCX 470 demonstrated consistent IOP-lowering effects regardless of baseline pressure, with a significantly higher proportion of patients achieving >10 mmHg reduction versus latanoprost. - Nicox remains on track for U.S. New Drug Application submission in H1 2026, with Denali Phase 3 trial results expected in Q3 2025.
- The ocular hypertension market is expanding due to increased prevalence of conditions affecting aqueous humor outflow, leading to elevated intraocular pressure (IOP). - Advancements like sustained-release implants and micro-dosing technologies are enhancing patient compliance and improving outcomes in ocular hypertension treatment. - Enhanced imaging techniques, such as optical coherence tomography (OCT), facilitate early diagnosis and intervention, contributing to the growth of the ocular hypertension market. - Over 60 companies are actively developing more than 70 pipeline drugs for ocular hypertension, signaling robust innovation and future growth potential in the domain.
- Nicox SA announced its Denali Phase 3 trial of NCX 470 for open-angle glaucoma or ocular hypertension is fully enrolled in China, accelerating the overall trial timeline. - The Denali trial evaluates the efficacy and safety of NCX 470 ophthalmic solution compared to latanoprost, with topline results expected in Q3 2025. - NCX 470 demonstrated robust efficacy and safety in the Mont Blanc trial, meeting efficacy requirements for potential U.S. approval. - Nicox is focusing on commercialization routes for NCX 470 in the U.S., with a potential NDA submission anticipated in H1 2026, pending partnership or financing.
- Nicox has entered a $16.5 million financing agreement with Soleus, combining royalty sales and equity financing to fund operations into Q3 2025. - Soleus acquired Nicox's VYZULTA royalties for $15 million and invested $1.5 million in Nicox shares with warrants, priced at a premium. - The agreement includes repayment of €5.2 million of Nicox’s debt by June 2025, significantly reducing the company's financial burden. - Topline results from the NCX 470 Denali Phase 3 clinical trial for glaucoma are now expected in Q3 2025 due to accelerated patient recruitment.
- Ocumension Therapeutics, Nicox's partner, has received approval in China to commercialize ZERVIATE for treating ocular itching linked to allergic conjunctivitis. - The approval of ZERVIATE marks the first cetirizine ophthalmic solution available in China, addressing a significant gap in treatment options for allergic conjunctivitis. - Nicox stands to gain a new revenue stream through royalties, ranging from 5% to 9% of Ocumension's net sales, along with potential sales milestones. - Ocumension plans to manufacture ZERVIATE locally and target peak annual sales exceeding $100 million within seven years, addressing a market expected to reach $500 million by 2030.
- Nicox has completed recruitment and randomization of the final patient in the United States for its Denali Phase 3 trial evaluating NCX 470, a novel NO-donating bimatoprost eye drop for open-angle glaucoma and ocular hypertension. - The trial compares NCX 470 ophthalmic solution 0.1% to latanoprost 0.005% across the U.S. and China, with more than 95% of the targeted patient number already randomized. - Topline results are expected in the second half of 2025, with the U.S. New Drug Application submission anticipated in the first half of 2026. - Previous Mont Blanc Phase 3 trial results showed NCX 470 achieved statistical non-inferiority versus latanoprost and demonstrated superiority at 4 out of 6 timepoints, meeting U.S. efficacy requirements for approval.
