nanocrystalline form of fluticasone (AC-155) / Nicox, Ocumension Therap - LARVOL DELTA

Mississippi: Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension for the Treatment of Blepharitis (clinicaltrials.gov) - P2b | N=224 | Completed | Sponsor: Nicox Ophthalmics, Inc. | N=320 ➔ 224

Enrollment change • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Nicox (BIO 2022) - "Our ophthalmic pipeline includes two programs in clinical development, NCX 470 targeting glaucoma and NCX 4251 targeting dry eye disease. We also have two products which are commercialized in the U.S., VYZULTA® (latanoprostene bunod ophthalmic solution) 0.024% and ZERVIATE® (cetirizine ophthalmic solution) 0.24%, for use in patients with open-angle glaucoma and ocular allergic conjunctivitis, respectively."

Conjunctivitis • Dry Eye Disease • Glaucoma • Ocular Infections • Ocular Inflammation • Ophthalmology

Eyelid Application of NCX 4251 for Treatment of Signs and Symptoms of Dry Eye Disease (ARVO 2022) - "NCX 4251 Ophthalmic Suspension, 0.1% was effective, safe and well tolerated. NCX 4251 has the potential to provide a safe and efficacious short-term treatment for DED. The encouraging findings from this post hoc analysis must be confirmed in larger prospective clinical trials."

Dry Eye Disease • Ocular Inflammation • Ophthalmology

Mississippi: Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension for the Treatment of Blepharitis (clinicaltrials.gov) - P2b; N=320; Completed; Sponsor: Nicox Ophthalmics, Inc.; Recruiting ➔ Completed; Trial completion date: Dec 2021 ➔ Jun 2021; Trial primary completion date: Dec 2021 ➔ Jun 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Mississippi: Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension for the Treatment of Blepharitis (clinicaltrials.gov) - P2b; N=300; Recruiting; Sponsor: Nicox Ophthalmics, Inc.

Clinical • New P2b trial • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology

[VIRTUAL] Oncolytic poliovirus as a probe for mechanisms of immune resistance in glioblastoma (SNO 2020) - "We have constructed a pathological model using murine CT2ACD155 intracranial tumors stereotactically infused with a single dose of PVSRIPO (5×107 pfu) or mock control to study the response of glioblastoma in an immune competent in vivo tumor microenvironment. This model is valuable in studying the mechanisms of intrinsic resistance and the timeline of resistance to develop in order to obtain more durable immunotherapy responses in glioblastoma. Future steps are to track inflammation induced by viral infection by RNAseq, and to find potential therapeutic interventions (including blocking PD1:PD-L1 axis) to mitigate therapy resistance in this preclinical model."

IO Biomarker • Oncolytic Virus • Glioblastoma • Immunology • Infectious Disease • Inflammation • Oncology • Solid Tumor • CASP3 • CD8

[VIRTUAL] Prospective Study of NCX 4251 (fluticasone propionate nanocrystals ophthalmic suspension, 0.1%) for Treatment of Blepharitis (ASCRS-ASOA 2020) - "Conclusion NCX 4251 has the potential to provide an effective and rapid relief of signs and symptoms of blepharitis and dry eye. The well-known efficacy of fluticasone propionate in treating inflammation, along with the safety profile of the novel formulation and its delivery method represent an important advance in the treatment of this debilitating disease."

Clinical • Dry Eye Disease • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

Nicox finalizes acquisition of Aciex Therapeutics (Healio) - "The company is also developing the therapeutic candidate, AC-155, to treat postoperative inflammation and pain and is expected to begin a phase 2 trial next year..."

Anticipated new P2 trial • Inflammation • Pain

Nicox reports strong revenue growth in 2015 and provides corporate update (GlobeNewswire) - "NCX 4251, a novel form of fluticasone propionate being developed for blepharitis, is now in formulation studies, with the goal of entering directly into Phase 2."

Pipeline update

Nicox Fourth Quarter 2019 Business Update and Financial Highlights (GlobeNewswire, NICOX) - "NCX 4251: Meeting with the U.S. FDA is scheduled in Q1 2020 to discuss the next steps of the development plan. ZERVIATE U.S. launch: Commercial launch of ZERVIATE (cetirizine ophthalmic solution), 0.24% in the U.S. is planned in H1 2020 by Nicox’s partner Eyevance Pharmaceuticals, LLC. The total number of prescriptions1 for VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, in the U.S. in the fourth quarter of 2019 increased by 12% compared to the third quarter 2019 and by 72% compared to the fourth quarter of 2018."

Clinical • Clinical data • Commercial • Launch • Regulatory

Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis (clinicaltrials.gov) - P2; N=44; Completed; Sponsor: Nicox Ophthalmics, Inc.; Recruiting ➔ Completed

Clinical • Trial completion

Nicox’s NCX 4251 meets primary endpoint in phase 2 blepharitis trial and shows promising efficacy in dry eye disease (GlobeNewswire) - P2, N=36; Danube(NCT03926026); Sponsor: Nicox Ophthalmics, Inc; "Nicox SA...today announced that NCX 4251...has met the primary objective of its U.S. multicenter, dose escalating, first-in-human, Phase 2 clinical trial (referred to as ‘Danube’) evaluating the safety and tolerability of NCX 4251 in patients with acute exacerbations of blepharitis....NCX 4251 0.1% once daily (QD) treatment was selected to advance into a larger Phase 2b clinical trial, pending the outcome of a meeting with the U.S. Food and Drug Administration (FDA) in early 2020."

FDA event • P2 data

Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Nicox Ophthalmics, Inc.

Clinical • New P2 trial

Nonclinical Evaluation of NCX 4251, a Novel Steroid Therapy for Blepharitis, Targeted Directly to the Eyelid Margin to Improve Efficacy and Reduce the Potential for IOP Elevations (ASCRS-ASOA 2019) - "Conclusion In this preclinical evaluation, safety and tolerability of eyelid administration of a novel fluticasone propionate nanocrystal ophthalmic suspension was evaluated in Beagle dogs. NCX 4251 was safe and well tolerated in this preclinical study performed in preparation for initiation of a clinical program in blepharitis patients."

Clinical

Nonclinical Evaluation of NCX 4251, a Novel Steroid Therapy for Blepharitis, Targeted Directly to the Eyelid Margin to Improve Efficacy and Reduce the Potential for IOP Elevations (ASCRS-ASOA 2019) - "Conclusion In this preclinical evaluation, safety and tolerability of eyelid administration of a novel fluticasone propionate nanocrystal ophthalmic suspension was evaluated in Beagle dogs. NCX 4251 was safe and well tolerated in this preclinical study performed in preparation for initiation of a clinical program in blepharitis patients."

Clinical

Nonclinical Evaluation of NCX 4251, a Novel Steroid Therapy for Blepharitis, Targeted Directly to the Eyelid Margin to Improve Efficacy and Reduce the Potential for IOP Elevations (ASCRS-ASOA 2019) - "Conclusion In this preclinical evaluation, safety and tolerability of eyelid administration of a novel fluticasone propionate nanocrystal ophthalmic suspension was evaluated in Beagle dogs. NCX 4251 was safe and well tolerated in this preclinical study performed in preparation for initiation of a clinical program in blepharitis patients."

Clinical

Nonclinical Evaluation of NCX 4251, a Novel Steroid Therapy for Blepharitis, Targeted Directly to the Eyelid Margin to Improve Efficacy and Reduce the Potential for IOP Elevations (ASCRS-ASOA 2019) - "Conclusion In this preclinical evaluation, safety and tolerability of eyelid administration of a novel fluticasone propionate nanocrystal ophthalmic suspension was evaluated in Beagle dogs. NCX 4251 was safe and well tolerated in this preclinical study performed in preparation for initiation of a clinical program in blepharitis patients."

Clinical

Preclinical Evaluation Of NCX 4251, A Novel Steroid Therapy For Blepharitis, Targeted Directly To The Eyelid Margin To Reduce The Potential For IOP Elevations (AGS 2019) - "NCX 4251 (fluticasone propionate nanocrystal suspension) was well tolerated in preclinical evaluations in Beagle dogs. Direct application of NCX 4251 to the eyelid margin via an applicator has the potential for improved clinical efficacy. Additionally, due to the reduced intraocular tissue exposure to the steroid when compared to eye drops, there is also a reduced potential for AEs of IOP elevations."

Preclinical