travoprost punctal plug (OTX-TP) / Ocular 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

A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert (clinicaltrials.gov) - P3; N=40; Completed; Sponsor: Ocular Therapeutix, Inc.; Active, not recruiting ➔ Completed; Trial completion date: Feb 2020 ➔ Sep 2020

Clinical • Trial completion • Trial completion date • Glaucoma • 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

OTX-TP: Top-line efficacy data from P3 trial (NCT02914509) in glaucoma and ocular hypertension by the end of 2018 (Morgan Stanley Global Healthcare Unplugged Conference 2017, Ocular Therapeutix)

P3 data: top line • Glaucoma • Ophthalmology

OTX-TP: Top-line efficacy data from P3 trial (NCT02914509) in glaucoma and ocular hypertension by the end of 2018 (Morgan Stanley Global Healthcare Unplugged Conference 2017, Ocular Therapeutix)

P3 data: top line • Glaucoma • Ophthalmology

Ocular Therapeutix to present data on anterior and posterior segment drug product candidates at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting (Businesswire) - "Ocular Therapeutix...today announced that 11 abstracts on drug product candidates incorporating its proprietary hydrogel platform technology will be presented at the Association for Research in Vision and Ophthalmology...Clinical data on some of the Company’s current pipeline products including DEXTENZA...0.4 mg, OTX-TP (travoprost insert) and OTX-TKI...will be presented during the conference."

Clinical data • Glaucoma • Ophthalmology

A PROSPECTIVE, RANDOMIZED, MULTI-CENTER PHASE 2 STUDY EVALUATING TRAVOPROST INTRAOCULAR IMPLANTS COMPARED TO TIMOLOL: THREE-MONTH INTERIM RESULTS (EGS 2018) - "This study is designed to evaluate initial safety and efficacy of two Travoprost Intraocular Implants, one with fast-elution rate and one with slow-elution rate (referred to as iDose-slow and iDose-fast) compared to timolol maleate ophthalmic solution, 0.5%, in subjects with OHT or OAG taking 0-3 ocular medication(s). The iDose is a novel sustained-release travoprost implant which anchors into the sclera via the trabecular meshwork... Interim results of this phase 2 trial demonstrate initial efficacy of both the iDose-fast and iDose-slow implants through Month 3, with at least 30% IOP reduction. An excellent safety pro le was observed with no hyperemia, intraoperative or serious ocular AEs reported to date in the implant groups. Two phase 3 pivotal trials are currently being planned."

Clinical • P2 data • Ophthalmology

Study Evaluating OTX-TP in OAG and OH (clinicaltrials.gov) - P3a; N=550; Recruiting; Sponsor: Ocular Therapeutix, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Biosimilar • Cardiovascular • Glaucoma • Ophthalmology

Ocular Therapeutix: Q4 2015 Results (Ocular Therapeutix) - “…meeting with the FDA in January of 2016…we have announced that our Phase 3 development program for OTX-TP in glaucoma and hypertension. The planned trial design for the two Phase 3 clinical trials includes an OTX-TP treatment arm and a placebo controlled comparator arm that would use a non-drug eluting intracanalicular depot. We do not expect our Timolol comparator, our validation arm will be required in the study design and do not expect that eye drops of placebo or active will be administered in either arm. We expect that the FDA will require the OTX-TP to show a statistically superior reduction of intraocular pressure compared to the placebo as a primary efficacy end point while also inducing a clinically meaningful IOP reduction…expect to initiate the first of the two planned Phase 3 clinical trials in the third quarter of 2016 after holding an end of Phase 2 meeting with the FDA in the second quarter of 2016.”

Anticipated FDA event • Anticipated new P3 trial • Eye Care

Ocular Therapeutix reports first quarter 2016 financial results and provides corporate update (Ocular Therapeutix Press Release) - "...the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of July 24, 2016 for the NDA...and launch this product in early 2017."; Anticipated topline P3 data of DEXTENZA for post-surgical ocular inflammation and pain in Q4 2016. ; Anticipated topline P3 data of DEXTENZA for the treatment of allergic conjunctivitis in Jun 2016; Anticipated new P3 trial for OTX-TP for Glaucoma and Ocular Hypertension Q3 2016.

Anticipated launch • Anticipated new P3 trial • Anticipated P3 data: top line • PDUFA date • Glaucoma • Ocular Inflammation • Ophthalmology

Ocular Therapeutix begins enrollment in first phase 3 clinical trial with OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension (Ocular Therapeutix Press Release) - "Ocular Therapeutix...announced the enrollment of the first patient in the first of two planned Phase 3 clinical trials with OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension...We expect topline results from the first Phase 3 clinical trial to be available in the first half of 2018, and plan to commence the second phase 3 clinical trial in the first half of 2017."

Anticipated P3 data: top line • Anticipated trial initiation date • Enrollment open • Glaucoma • Ophthalmology

Ocular Therapeutix: Annual Report 2015 (Ocular Therapeutix) - “OTX-TP Two Month Formulation: Mean 8:00 a.m. IOP Reduction from Baseline"

Clinical data • Glaucoma • Ophthalmology

OTX-TP: Patents expiry in US, Japan and EU related to compositions and methods of use in 2030 (Ocular Therapeutix) - Annual Report 2017: Patent expiry in US related to hydrogel composition of the intracanalicular inserts and methods of making and using hydrogel implants between 2018 and 2020; Patent expiry in US in 2018; Patent expiry in US related to process of making the hydrogel composition in 2024

Patent • Glaucoma • Ophthalmology

Ocular Therapeutix: Investor Day (Ocular Therapeutix) - "Phase 2b IOP Reduction"; "Mean 8 am Reduction from Baseline"; "Influence of Visualization of Depot on IOP: Mild effect on Mean IOP, Depot material may still be present in partially resorbed state"; "OTX-13-004: Depot visualized at Day 75, but not at Day 90 - Observed data"

P2b data • Glaucoma • Ophthalmology

OTX-TP: Initiation of safety extension P3 trial for glaucoma in Q2 2018 (Ocular Therapeutix) - Q1 2018 Results: Topline efficacy data from P3 trial (NCT02914509) for glaucoma in H1 2019

New P3 trial • P3 data: top line • Glaucoma • Ophthalmology

Ocular Therapeutix: Annual Report 2015 (Ocular Therapeutix) - “OTX-TPa and OTX-TPb Formulations, Compared to Timolol + Placebo Plug: Mean 8:00 a.m. IOP Reduction from Baseline”

P2a data • Glaucoma • Ophthalmology

Ocular Therapeutix: Annual Report 2015 (Ocular Therapeutix) - “OTX-TP One Month Formulation: Mean 8:00 a.m. IOP Reduction from Baseline”

P1 data • Ophthalmology

Evaluation of the Safety and Efficacy of OTX-TP, an intracanalicular travoprost insert, for the treatment of patients with open-angle glaucoma or ocular hypertension: A Phase 3 Study (ARVO 2020) - "The most common ocular adverse events seen in the study eye were dacryocanaliculitis (approximately 7% in OTX-TP vs. 3% in placebo) and lacrimal structure disorder (approximately 6% in OTX-TP vs. 4% in placebo).Conclusions OTX-TP exhibits fair IOP lowering with a single insert, with a greater magnitude of effect early in the drug’s lifecycle. Adverse events were transient, mild and resolved over time."

Clinical • P3 data

Ocular Therapeutix reports third quarter 2019 financial results and business update (Businesswire) - "The Company recently completed its Type C meeting with the FDA to discuss OTX-TP. While the FDA did not feel that the data from this trial met the standard of clinical meaningfulness in the population studied, there were constructive discussions about potential pathways forward in specific patient populations for whom drops are problematic. Given the feedback, there are no immediate plans to bring this program forward without the assistance of a partner."

FDA event

OTX-TP: FDA meeting to discuss P3 trial results on October 30, 2019 (Ocular Therapeutix, Cantor Fitzgerald Global Healthcare Conference 2019)

FDA event

OTX-TP: FDA meeting to discuss P3 trial results on October 30, 2019 (Ocular Therapeutix, Cantor Fitzgerald Global Healthcare Conference 2019)

FDA event

OTX-16-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-TP in Subjects With Open-Angle Glaucoma and Ocular Hypertension (clinicaltrials.gov) - P3a; N=550; Completed; Sponsor: Ocular Therapeutix, Inc.; Recruiting ➔ Completed; Trial primary completion date: Dec 2018 ➔ Mar 2019

Clinical • Trial completion • Trial primary completion date

A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert (clinicaltrials.gov) - P3; N=40; Active, not recruiting; Sponsor: Ocular Therapeutix, Inc.

Clinical • New P3 trial

Ocular Therapeutix reports second quarter 2019 financial results and business update (Ocular Therapeutix Press Release) - "OTX-TP...for the reduction of elevated intraocular pressure in patients with glaucoma: The Company plans to meet with the FDA in the second half of 2019 to discuss results from its Phase 3 clinical trial and determine appropriate steps forward."

P3 data: top line

OTX-TP: “Reductions from baseline for OTX-TP treated subjects in this trial ranged from 3.27-5.72 millimeters of mercury (mm Hg)”; Glaucoma (Ocular Therapeutix, Raymond James 2019 Life Sciences and MedTech Conference)

P3 data: top line