Dexamethasone SR is under clinical development by Ocular Therapeutix and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Dexamethasone SR’s likelihood of approval (LoA) and phase transition for Keratoconjunctivitis Sicca (Dry Eye) took place on 21 Oct 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Dexamethasone SR Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Dexamethasone SR overview

Dexamethasone (Dextenza) is a hydroxysteroid derivative, acts as an anti inflammatory agent. It is formulated as sustained release implant (insert) for intracanalicular insertion. Dextenza is indicated for the treatment of ocular pain and inflammation following ophthalmic surgery. Dextenza is indicated for the treatment of ocular itching associated with allergic conjunctivitis.

Dexamethasone (OTX-DP) is under development for treatment of inflammatory dry eye disease and ocular itching in allergic conjunctivitis. The drug candidate is a sustained release dexamethasone intracanalicular depot. It is a hydrogel-based punctum plug that delivers sustained and tapered-release dexamethasone for up to 30 days up on single insertion. Dexamethasone is a synthetic glucocorticoid. It is also under development for the treatment of post-surgical ocular inflammation and pain in children following cataract surgery.

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Ocular Therapeutix overview

Ocular Therapeutix is a biopharmaceutical company that discovers, develops and commercializes therapies for treating eye diseases. The company’s lead product candidate DEXTENZA is used for the treatment of post-surgical Ocular inflammation and pain. Its pipeline products include OTX-TP, used for treating glaucoma and Ocular hypertension; OTX-BPI, targeting acute Ocular pain; OTX-BDI, against post-op pain, inflammation and anti-bacterial infections; OTX-KTO for treating allergic conjunctivitis; OTX-CSI, against dry eye. Ocular Therapeutix also develops intracameral implants for treating multiple eye disorders. The company works in collaboration with Regeneron Pharmaceuticals Inc to develop formulations for the treatment of wet AMD and other serious retinal diseases. Ocular Therapeutix is headquartered in Bedford, Massachusetts, the US.

Quick View Dexamethasone SR LOA Data

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Dexamethasone SR
Administration Pathway
  • Ophthalmic
Therapeutic Areas
  • Central Nervous System
  • Ophthalmology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.