Paxtrava (travoprost intracameral implant) / Ocular Therap, AffaMed Therap - LARVOL DELTA

A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT) (clinicaltrials.gov) - P2 | N=83 | Completed | Sponsor: Ocular Therapeutix, Inc. | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Glaucoma • Ophthalmology

Travoprost Intracameral Implant: A Review on the Novel Treatment Modality for Open-Angle Glaucoma and Ocular Hypertension. (PubMed, Ann Pharmacother) - "A literature search was conducted from drug discovery until September 2024 through PubMed, MEDLINE, and National Institutes of Health Clinical Trials Registry utilizing the following search terms: iDose, travoprost, intracameral implant, OTX-TIC, open-angle glaucoma, and ocular hypertension...With a duration of 3 years and removal of the need for patient dexterity and application compliance, the travoprost implant serves an unmet need for patients and prescribers. Travoprost intracameral implant is a safe and effective delivery system for intracameral travoprost administration for patients with OAG or ocular hypertension."

Journal • Review • Cardiovascular • Glaucoma • Ophthalmology

A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT) (clinicaltrials.gov) - P2 | N=105 | Active, not recruiting | Sponsor: Ocular Therapeutix, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Glaucoma • Ophthalmology

The XU Study: Rates and Risk Factors of Contact Between the OTX-TIC Intracameral Ocular Implant and Corneal Endothelium (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: University of Southern California | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2023 ➔ May 2024

Enrollment open • Trial completion date

A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT) (clinicaltrials.gov) - P2 | N=105 | Recruiting | Sponsor: Ocular Therapeutix, Inc. | Trial completion date: Jul 2023 ➔ Jan 2025 | Trial primary completion date: Feb 2023 ➔ Jan 2024

Trial completion date • Trial primary completion date • Cardiovascular • Glaucoma • Ophthalmology

Rates and Risk Factors of Contact Between the OTX-TIC Intracameral Ocular Implant and Corneal Endothelium (clinicaltrials.gov) - P=N/A | N=100 | Not yet recruiting | Sponsor: University of Southern California

New trial

Preclinical Safety and Tolerability of Repeated Intracameral Travoprost Implant (OTX-TIC) Administrations (ARVO 2023) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Preclinical • Glaucoma • Ophthalmology

CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension (clinicaltrials.gov) - P1 | N=19 | Completed | Sponsor: Ocular Therapeutix, Inc. | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Glaucoma • Ophthalmology

Safety and Pharmacodynamic Assessment of Repeated Intracameral Travoprost Implant Administration in Beagle Dogs (ARVO 2022) - "Multiple, repeated OTX-TIC administrations were generally safe and well-tolerated with no signs of inflammation observed and produced a clinically meaningful reduction in IOP through 30 weeks in beagles. OTX-TIC is currently being investigated in a Phase 2 clinical trial in the US. Images: Mean Reduction in Intraocular Pressure from Baseline Mean Conjunctival Hyperemia and Pupillary Reflex Scores"

Clinical • PK/PD data • Glaucoma • Ophthalmology

A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT) (clinicaltrials.gov) - P2 | N=105 | Recruiting | Sponsor: Ocular Therapeutix, Inc.

New P2 trial • Glaucoma • Ophthalmology

Sustained release glaucoma therapies: Novel modalities for overcoming key treatment barriers associated with topical medications. (PubMed, Ann Med) - P1, P2, P2a, P3, P3a | "Currently, Bimatoprost SR (Durysta) from Allergan plc is the only FDA-approved SR therapy for POAG. Other SR therapies under investigation include: bimatoprost ocular ring (Allergan) (ClinicalTrials.gov identifier: NCT01915940), iDose (Glaukos Corporation) (NCT03519386), ENV515 (Envisia Therapeutics) (NCT02371746), OTX-TP (Ocular Therapeutix) (NCT02914509), OTX-TIC (Ocular Therapeutix) (NCT04060144), and latanoprost free acid SR (PolyActiva) (NCT04060758). Additionally, a wide variety of technologies for SR therapeutics are under investigation including ocular surface drug delivery systems such as contact lenses and nanotechnology. While challenges remain for SR drug delivery technology in POAG management, this technology may shift treatment paradigms and dramatically improve outcomes."

Journal • Glaucoma • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain

Hydrogel-Based, Sustained-Release Intracameral Travoprost Implant for Glaucoma Therapy: A Phase 1 Clinical Trial (AAO 2021) - "AEs included iritis (n = 6; all cohorts) and peripheral anterior synechiae (n = 3; Cohort 1 only). Conclusion A single OTX-TIC implant reduced IOP similar to topical travoprost with durations of 6+ months (Cohorts 1 and 2) and 3-6 months (Cohorts 3 and 4), consistent resorption and a favorable safety profile."

Clinical • P1 data • Glaucoma • Ocular Inflammation • Ophthalmology • Uveitis

Evaluating Safety, Tolerability & Efficacy of a Hydrogel-Based Intracameral Travoprost Implant in Glaucoma Patients:Phase-1 Interim Analyses (ASCRS-ASOA 2021) - "OTX-TIC has a favorable safety profile and was generally well tolerated with consistent resorption and no movement to date. OTX-TIC will be evaluated in an upcoming phase 2 clinical study."

Clinical • P1 data • Glaucoma • Immunology • Inflammation • Ophthalmology

CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension (clinicaltrials.gov) - P1; N=19; Active, not recruiting; Sponsor: Ocular Therapeutix, Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Mar 2021 ➔ Nov 2021; Trial primary completion date: Oct 2020 ➔ May 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Glaucoma • Ophthalmology

[VIRTUAL] Phase 1 Study of an Intracameral Travoprost Hydrogel-based Implant for the Treatment of POAG and Ocular Hypertension (ARVO 2021) - "OTX-TIC showed similar IOP control compared to topical travoprost therapy in subjects with POAG or OHT which was sustained for at least 6 months in many subjects. OTX-TIC was generally well tolerated with a favorable safety profile. Durability of IOP lowering effect was longest and most consistent in Cohort 2."

P1 data • Glaucoma • Ocular Inflammation • Ophthalmology

Medical anti-glaucoma therapy: Beyond the drop. (PubMed, Vet Ophthalmol) - "Intracameral devices include the following: Allergan's Durysta Bimatoprost SR, Envisia Therapeutics' ENV515 travoprost implant, Glaukos' iDose , Ocular Therapeutix's OTX-TIC travoprost implant, and Santen's polycaprolactone implant with PGE2-derivative DE-117. Other prostaglandin-based technologies include Allergan's bimatoprost ring (placed in the conjunctival fornix), Ocular Therapeutics' OTX-TP intracanalicular travoprost implant, subconjunctival latanoprost in a liposomal formulation, and the PGE2 derivative PGN 9856-isopropyl ester that is applied to the periorbital skin...Stem cell technology can repopulate depleted tissues or, in the case of Neurotech's Renexus® NT-501 intravitreal implant, serve as a living drug delivery device that continuously secretes neurotrophic factors. Other unique approaches involve nanotechnology, nasal sprays that deliver drug directly to the optic nerve and noninvasive alternating current..."

Journal • Review • Fibrosis • Gene Therapies • Glaucoma • Immunology • Ophthalmology

Study of Exchange of Travoprost Intraocular Implant (clinicaltrials.gov) - P2; N=45; Not yet recruiting; Sponsor: Glaukos Corporation

Clinical • New P2 trial • Glaucoma • Ophthalmology

"$OCUL and AffaMed Therapeutics Announce License Agreement and Collaboration for DEXTENZA and OTX-TIC in Asia. $12M upfront" (@BioStocks)

Evaluating Safety, Tolerability and Efficacy of an Intracameral Hydrogel-Based Travoprost Implant in Subjects with Glaucoma - Phase 1 Trial (ASCRS-ASOA 2020) - "It has remained localized to site of insertion. Implant resorbs in 5-7 months (low and high dose cohorts) with consistent IOP-lowering effect with a single insert observed for over a year in at least one patient."

Clinical • P1 data • Glaucoma • Hypertension • Immunology • Ophthalmology

[VIRTUAL] Evaluating Safety, Tolerability and Efficacy of an Intracameral Hydrogel-Based Travoprost Implant in Subjects with Glaucoma - Phase 1 Trial (ASCRS-ASOA 2020) - "It has remained localized to site of insertion. Implant resorbs in 5-7 months (low and high dose cohorts) with consistent IOP-lowering effect with a single insert observed for over a year in at least one patient."

Clinical • P1 data • Glaucoma • Hypertension • Immunology • Ophthalmology

CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Ocular Therapeutix, Inc.

Clinical • New P1 trial • Cardiovascular • Glaucoma • Hypertension • Ophthalmology

Evaluating Safety, Tolerability and Efficacy of an Intracameral Hydrogel-Based Travoprost Implant in Subjects with Glaucoma - Phase 1 Trial (ARVO 2020) - "It has remained localized to site of insertion. Implant resorbs in 5-7 months (low and high dose cohorts) with consistent IOP-lowering effect with a single insert observed for over a year in at least one patient."

Clinical • P1 data

Effect of Hydrogel Persistence on Pharmacodynamics and Tolerability of OTX-TIC, Travoprost Intracameral Implant in Beagles (ARVO 2020) - "The release of travoprost is controlled by the encapsulated travoprost particles dispersed from the hydrogel matrix into the anterior chamber over time. No clinically significant change was observed in CCT or ECD over the course of the study indicating no damage to the corneal endothelium due to the implant."

PK/PD data

Pharmacokinetics of OTX-TIC, a Sustained Release Travoprost Intracameral Implant in Rabbits (ARVO 2019) - "Conclusions OTX-TIC delivers sustained TFA levels to the AH comparable to the Cmax delivered from a Travatan Z eye drop in NZW rabbits. As OTX-TIC resides in the inferior iridocorneal angle, it potentially releases therapeutic concentrations of TFA into the AH demonstrating promise as a potential sustained release glaucoma treatment."

PK/PD data

A Prospective, Multicenter, Open-Label First-in-Human Study to Evaluate the Safety, Tolerability and Efficacy of OTX-TIC (travoprost) Implant in Subjects with Primary Open-Angle Glaucoma or Ocular Hypertension: Preliminary Findings (ARVO 2019) - "The implant resorbs over 5-7 months and localizes to the inferior anterior chamber. Adverse events were minimal and mild and resolved over the course of the study."

Clinical • P1 data