Glaukos | 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.

Glaukos' iDose TR Shows Sustained IOP Reduction in Glaucoma Patients

4 months ago

• Glaukos announced positive 36-month follow-up data from Phase 3 trials of iDose TR, demonstrating sustained intraocular pressure (IOP) reduction in glaucoma patients. • Approximately 70% of patients treated with iDose TR remained well-controlled on the same or fewer IOP-lowering medications compared to 58% in the timolol control group. • A Phase 4 study showed iDose TR, when implanted during cataract surgery, achieved a mean IOP reduction of 11.3 mmHg (44%) at six months post-operation. • Glaukos has initiated Phase 2b/3 clinical trials for iDose TREX, a next-generation sustained-release platform with nearly double the drug capacity of iDose TR.

Glaukos' Epioxa NDA Accepted by FDA for Keratoconus Treatment

5 months ago

• Glaukos announced FDA acceptance of its New Drug Application (NDA) for Epioxa, a novel therapy for keratoconus. • Epioxa is a next-generation, non-invasive corneal cross-linking therapy designed to strengthen corneal tissue. • The FDA has set a PDUFA goal date of October 20, 2025, for the completion of its review of the Epioxa NDA. • Phase 3 trials demonstrated that Epioxa achieved primary efficacy endpoints with favorable safety and tolerability.

Nicox's NCX 470 Phase 3 Glaucoma Trial Fully Enrolled in China Ahead of Schedule

6 months ago

• 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.

Glaukos' Epioxa Shows Positive Phase 3 Results for Keratoconus Treatment

7 months ago

• Glaukos' Epioxa met its primary efficacy endpoint in a Phase 3 trial, showing a statistically significant improvement in maximum corneal curvature (Kmax) at 12 months compared to placebo. • The company plans to submit a New Drug Application (NDA) to the FDA by the end of the year, based on this trial and a previous Phase 3 study. • Epioxa is designed to strengthen corneal tissue using a minimally invasive procedure, offering a potential improvement over existing treatments by not requiring removal of the corneal epithelium. • The treatment was well-tolerated, with no discontinuations due to treatment-emergent adverse events, supporting its potential as a safe and effective option for keratoconus.

Nurix Therapeutics Advances BTK Degrader NX-5948 and Reinitiates NX-2127 Trial

7 months ago

• Nurix Therapeutics initiated Phase 1b dose expansion of NX-5948 in CLL patients with Fast Track designation, also expanding to WM, follicular lymphoma, and marginal zone lymphoma. • Enrollment has reinitiated for NX-2127 in a Phase 1a/b trial in oncology, utilizing a new chirally controlled drug product for dose escalation studies. • Preclinical data on Degrader-Antibody Conjugates (DACs) were presented, highlighting a novel therapeutic class with potential for improved therapeutic index and broader applicability.