Nicox | MedPath

NCX 470 Shows Superior IOP Control Over Latanoprost in Mont Blanc Trial Analysis

3 months ago

• 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.

Ocular Hypertension: Over 60 Companies Advance Clinical Trial Pipeline

4 months ago

• 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.

Ocumension Therapeutics Completes Enrollment in Phase III Trial of OT-301 for Glaucoma and Ocular Hypertension

6 months ago

• Ocumension Therapeutics has completed enrollment for its second Phase III clinical trial, Denali, of OT-301 (NCX 470) in China. • The Denali trial evaluates the safety and efficacy of OT-301 0.1% ophthalmic solution versus latanoprost 0.005% for lowering intraocular pressure (IOP). • OT-301 is a first-in-class nitric oxide (NO)-donating prostaglandin analog being jointly developed by Nicox S.A. and Ocumension. • The trial enrolled over 670 patients across approximately 90 clinical sites in the United States and China, including a long-term safety extension.

Nicox Secures $16.5 Million Financing to Advance NCX 470 Glaucoma Trial

7 months ago

• 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.

Regulatory Roundup: Key Approvals and Submissions in Late September 2024

8 months ago

• Apellis received regulatory approval for its geographic atrophy treatment, offering a new option for patients facing this vision-threatening condition. • Glycomine secured orphan drug designation for its therapeutic aimed at addressing a rare metabolic disorder, potentially expediting its development. • Regulatory submissions and approvals spanned multiple companies, including Merck, Novartis, and Sanofi, highlighting continued pharmaceutical innovation.

Nicox's ZERVIATE Approved in China for Allergic Conjunctivitis

8 months ago

• 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.