Ocular Therapeutix, Inc. announced positive Phase 2 data for PAXTRAVA (travoprost intracameral implant or OTX-TIC) in patients with open-angle glaucoma or ocular hypertension (reported together as ?glaucoma?, below) The data are being presented by Mark Gallardo, MD during the 2024 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. Summary of Data and Findings: Efficacy: PAXTRAVA 26 µg single implant demonstrated consistent IOP control through 6 months: Statistically significant IOP changes from baseline were observed for each and every individual and mean diurnal measurement at Week 2 (M0.5), Week 6 (M1.5), and Week 12 (M3), as well as Months 4.5 and 6 (p<0.0001), although no formal statistical testing was prespecified; Clinically meaningful mean IOP reduction of ~24-30% from baseline observed over six months and A majority (81.3%) of treated eyes did not require additional IOP-lowering therapy through 6 months indicating sustained and consistent treatment effects. Safety: PAXTRAVA 26 µg was generally well-tolerated: No impact on corneal endothelium was observed at 6 months following a single administration; Majority of adverse events (AEs) were mild in severity and generally resolved with topical medical treatment.

Most ocular AEs within 3 days were deemed related to the injection procedure by the investigators. Post injection AEs observed (>3 days post injection procedure) were consistent with the travoprost label. One implant required removal (classified as a serious adverse event), most likely due to a peri-implantation bacterial infection, per investigator and Consistent bioresorption of the implant coupled with the durable effect seen in the trial suggests redosing would be possible, without the risk of stacking implants.

The complete presentation (Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension: Results from a Phase 2 Clinical Trial) will be available in the Scientific and Medical presentations section of the Company?s investor website. Phase 2 Study Overview: The PAXTRAVA Phase 2 study was designed as a randomized, parallel-group, controlled study to evaluate the safety and efficacy of PAXTRAVA in subjects with open-angle glaucoma (?OAG?) or ocular hypertension (?OHT?) and reported together as ?glaucoma?, per above. Following a standard medication wash-out, patients were randomized 1:1:1 into one of three dosing groups (5 µg or 26 µg of PAXTRAVA or DURYSTA® (bimatoprost implant)), dosed in ?the study eye?

and followed for frequent assessments through the six month analysis point. Due to elevations in IOP observed in seven out of the 16 subjects enrolled in the PAXTRAVA 5 µg arm of the trial, the Company closed enrollment in this arm and continued with the PAXTRAVA 26 µg and DURYSTA arms of the trial. Safety and efficacy data presented at ASCRS and reported in this press release are based on the 26 µg dosing group, as a result.

The enrolled subjects had a mean age of 65 years and had been previously treated with a mean of about 1.2 IOP-lowering agents prior to study entry. The treatment groups were well balanced for key demographics and baseline characteristics. The primary efficacy endpoints included measurement of changes in intraocular pressure (IOP) at three diurnal measurements (8 AM, 10AM and 4 PM) at weeks 2, 6, 12 and secondary endpoints included measurements at all other visits including 4.5 and 6 months.

No formal statistical testing was prespecified in the clinical trial protocol or the statistical analysis plan. Other assessments included an evaluation of the need for additional IOP-lowering therapy, changes in endothelial count and central corneal thickness, as well as an evaluation of safety for the period. Summary of next steps: Seek an end-of-Phase 2 meeting with the FDA to finalize development plans for PAXTRAVA Phase 3 trials and move to a next generation, commercial injector that eases initiation of therapy.