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OTX-TPa ~4µg/day over 2 mos. with natural tears · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| OTX-TPa | EXPERIMENTAL | OTX-TPa is a hydrogel punctum plug eluting travoprost in sustained release of \~4µg/day over approximately 2 months. For study masking purposes, subjects in this arm will also have natural tears drops administered. |
| OTX-TPb | EXPERIMENTAL | OTX-TPb is a hydrogel punctum plug eluting travoprost in sustained release of \~3µg/day over approximately 3 months. For study masking purposes, subjects in this arm will also have natural tears drops administered. |
| Timolol | ACTIVE_COMPARATOR | Timolol Maleate (0.5%) ophthalmic solution dosed twice daily (BID). For study masking purposes, subjects in this arm will also have a hydrogel punctum plug with no drug placed for approximately 3 months. |
| Name | Type | Description |
|---|---|---|
| OTX-TPa ~4µg/day over 2 mos. with natural tears drops | DRUG | OTX-TPa is a hydrogel punctum plug eluting travoprost in a sustained release of \~4µg/day over 2 months. Subjects in this arm will also receive natural tears drops. |
| OTX-TPb ~3µg/day over 3 months with natural tears drops | DRUG | OTX-TPb is a hydrogel punctum plug eluting travoprost in a sustained release of \~3µg/day over 3 months. Subjects in this arm will also receive natural tears drops. |
| Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug | DRUG | Timolol Maleate (0.5%) ophthalmic solution dosed twice daily. Subjects in this arm will also have a hydrogel punctum plug without drug placed. |
Inclusion Criteria: * Subject must be greater than or equal to 18 years of age at Screening. * Subject must have a documented diagnosis of ocular hypertension, open angle glaucoma. * Subject has a mean baseline (Day -7 and Day 0) Hour 0 (T0) untreated IOP of ≥ 24 mm Hg and ≤ 34 mm Hg in each eye, a...
Top 5 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 6 | PHASE3 | Gen 2 Travoprost Intracameral, Travoprost |
| SpyGlass Pharma, Inc. | SGP | 5 | PHASE3 | Bimatoprost System, BIM-DRS |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | AGN-193408 |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE3 | Bimatoprost ophthalmic solution |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE1 | REGN22530 |
OTX-TPa is an investigational small molecule therapy being developed for the treatment of glaucoma, specifically open angle glaucoma. It is designed as a sustained-release formulation intended to deliver approximately 4 micrograms per day over two months alongside natural tears. It is not yet approved for any indication.
OTX-TPa is being developed by Ocular Therapeutix, Inc., which trades on the Nasdaq under the ticker symbol OCUL. The company is an ophthalmology-focused biopharmaceutical developer. The program is in Phase 1 clinical development for glaucoma.
OTX-TPa is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The completed study was a multi-arm feasibility study evaluating OTX-TP compared to timolol in subjects with open angle glaucoma.
OTX-TPa has been studied in one completed Phase 1 trial, NCT01845038, titled a multi-arm feasibility study evaluating OTX-TP compared to timolol in the treatment of subjects with open angle glaucoma. The trial enrolled 41 participants in South Africa and was randomized, double-blind, and active-controlled.
Yes. OTX-TPa is also referred to as OTX-TPa drops. Both names refer to the same investigational sustained-release glaucoma therapy developed by Ocular Therapeutix, designed to deliver approximately 4 micrograms per day over two months with natural tears.
The completed Phase 1 trial NCT01845038 enrolled adults aged 18 years and older of all sexes with open angle glaucoma. It was conducted in South Africa, was randomized, double-blind, and active-controlled, and enrolled 41 participants. Healthy volunteers were not eligible for this study.