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Privately held specialty biopharmaceutical company developing biodegradable, sustained‑release intraocular therapeutics using a proprietary extended‑release drug delivery platform. Focus areas include applying the platform to approved ophthalmic agents to reduce development risk, conducting late‑stage clinical trials in ophthalmology, regulatory submissions (NDA), and selective partnering/out‑licensing.

Industries

Biotechnology
Health Care
Pharmaceutical
Pharmaceutical Manufacturing

Nr. of Employees

medium (51-250)

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Patents

Systems, kits and methods for loading and delivering a small volume dose from a syringe

US-11931554-B2

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Systems, kits and methods for loading and delivering a small volume dose from a syringe

US-11097061-B2

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Dose guides for injection syringe

US-10799642-B2

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Use of sustained release dexamethasone in post-cataract surgery inflammation

US-10159683-B2

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Use of sustained release dexamethasone in post-cataract surgery inflammation

US-10028965-B2

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Dose guides for injection syringe

US-10022502-B2

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Products

Dexycu (intraocular dexamethasone suspension)

A biodegradable, extended‑release intraocular suspension of dexamethasone intended to be administered as a single small‑volume intraocular injection at the conclusion of ocular surgery to control postoperative inflammation.


Services

Collaborative development and selective out‑licensing to apply the sustained‑release intraocular delivery platform to third‑party drug candidates.

Expertise Areas

  • Ophthalmic drug delivery
  • Formulation development for sustained‑release depots
  • Clinical trial management for ophthalmology (Phase 2/3 and Phase 3)
  • Regulatory strategy and NDA preparation (including 505(b)(2))
  • Show More (2)

Key Technologies

  • Extended‑release intraocular depot formulations
  • Biodegradable sustained‑release formulations
  • Intracameral and intravitreal injection delivery
  • Controlled‑release formulation design
  • Show More (1)

News & Updates

Received U.S. Food and Drug Administration approval for an intraocular dexamethasone suspension indicated for treatment of postoperative inflammation following cataract surgery (single intraocular administration).

Pivotal randomized, double‑masked, placebo‑controlled Phase 3 trial reported statistically significant improvement in anterior chamber cell and flare endpoints with the sustained‑release intraocular dexamethasone formulation versus placebo.

Submitted a New Drug Application (NDA) to the U.S. FDA seeking marketing approval of the extended‑release intraocular dexamethasone product; submission supported by data from multiple clinical studies involving several hundred patients.

Orphan Drug Designation granted by the U.S. FDA for an intraocular melphalan product developed for treatment of retinoblastoma.


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