travoprost (ENV-515) / Envisia Therap - LARVOL DELTA

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

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

Envisia Therapeutics selected to present during anterior segment company showcase at 2016 Ophthalmalogy Innovation Summit (PRNewswire) - "Envisia Therapeutics today announced that it has been selected to present during the Anterior Segment Company Showcase at the 2016 Ophthalmology Innovation Summit (OIS) being held at 8:30am CDT on October 13, 2016 at the Planet Hollywood Hotel in Chicago, Illinois...Dr. Yerxa will present interim clinical data for the ENV515 travoprost XR glaucoma program..."

Anticipated clinical data • Conference • Ophthalmology

Safety and Efficacy of ENV515 Travoprost Extended Release (XR) in Patients With Bilateral Ocular Hypertension or Primary Open Angle Glaucoma (clinicaltrials.gov) - P2a; N=36; Recruiting; Sponsor: Envisia Therapeutics; Active, not recruiting ➔ Recruiting; Trial primary completion date: Oct 2017 ➔ Mar 2018

Enrollment open • Trial primary completion date • Biosimilar • Cardiovascular • Glaucoma • Ophthalmology

Envisia Therapeutics announces positive three-month interim results of low dose ENV515 in patients with glaucoma (PRNewswire) - P2, N=20; NCT02371746; "Envisia Therapeutics...today reported positive results from an interim three-month analysis of an ongoing 12-month safety and efficacy evaluation of the low dosage form of ENV515..."

P2 data • Glaucoma • Ophthalmology

Envisia Therapeutics releases interim ENV515 (travoprost XR) phase 2 data demonstrating 11-month duration-of-action after a single dose in patients with glaucoma (PRNewswire) - P2, N=41; NCT02371746; Sponsor: Envisia Therapeutics; "Envisia Therapeutics...released an interim analysis of the second cohort of its ENV515...phase 2 trial in patients with glaucoma showing a clinically meaningful reduction in intraocular pressure (IOP) for the entire 11-month evaluation period following a single administration...A clinically meaningful reduction in IOP over the initial 11 months indicates that ENV515 has the potential to become a once a year therapy for glaucoma patients."

P2 data • Glaucoma • Ophthalmology

Envisia Therapeutics releases ENV515 (travoprost XR) phase 2 data showing nine-month duration of action after a single dose in patients with glaucoma (PRNewswire) - "Envisia Therapeutics...released an interim analysis of its ENV515 (travoprost XR) phase 2 trial in glaucoma patients showing clinically meaningful reduction in intraocular pressure (IOP) for the entire nine-month evaluation period following a single administration. ENV515 also demonstrated an IOP lowering effect comparable to prestudy topical prostaglandin analogs...and in-study topical timolol maleate 0.5% ophthalmic solution...plan to initiate enrollment in a new cohort of this phase 2 trial by year-end..."

Anticipated trial initiation date • P2 data • Glaucoma • Ophthalmology

Safety and Efficacy of ENV515 Travoprost Extended Release (XR) in Patients With Bilateral Ocular Hypertension or Primary Open Angle Glaucoma (clinicaltrials.gov) - P2a; N=41; Completed; Sponsor: Envisia Therapeutics; Active, not recruiting ➔ Completed

Clinical • Trial completion