API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
Details:
YUTIQ (fluocinolone acetonide) intravitreal implant 0.18mg is being evaluated in phase 4 clinical trials for the treatment of chronic non-infectious uveitis and related intraocular inflammation.
Lead Product(s): Fluocinolone Acetonide
Therapeutic Area: Ophthalmology Product Name: Yutiq
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2024
Details:
The product ILUVIEN (fluocinolone acetonide) is a sustained release intravitreal implant injected into the back of the eye. ILUVIEN is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies.
Lead Product(s): Fluocinolone Acetonide
Therapeutic Area: Ophthalmology Product Name: Iluvien
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2023
Details:
Through the divestment, Alimera will receive global rights to YUTIQ outside of China, Hong Kong, Taiwan, Macau and Southeast Asia. YUTIQ® (fluocinolone acetonide) is indicated for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye.
Lead Product(s): Fluocinolone Acetonide
Therapeutic Area: Ophthalmology Product Name: Yutiq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alimera Sciences
Deal Size: $82.5 million Upfront Cash: $75.0 million
Deal Type: Divestment May 18, 2023
Details:
Under the agreement, Alimera and Horus have agreed to increase the commercialization efforts for ILUVIEN (fluocinolone acetonide) for both diabetic macular edema (DME) and non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in Europe.
Lead Product(s): Fluocinolone Acetonide
Therapeutic Area: Ophthalmology Product Name: Iluvien
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alimera Sciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 03, 2023
Details:
Iluvien (fluocinolone acetonide intravitreal implant) is designed to release sub-microgram levels of fluocinolone acetonide, a corticosteroid, for 36 months, to reduce the recurrence of disease, enabling patients to maintain vision longer with fewer injections.
Lead Product(s): Fluocinolone Acetonide
Therapeutic Area: Ophthalmology Product Name: Iluvien
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2023
Details:
PALADIN phase 4 data demonstrate ILUVIEN (fluocinolone acetonide) patients experienced on average an increase in visual acuity, a significant decrease in retinal thickness and a predictable and manageable safety profile over 36 months.
Lead Product(s): Fluocinolone Acetonide
Therapeutic Area: Ophthalmology Product Name: Iluvien
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2022
Details:
The product ILUVIEN (fluocinolone acetonide) is a sustained release intravitreal implant injected into the back of the eye. ILUVIEN is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies.
Lead Product(s): Fluocinolone Acetonide
Therapeutic Area: Ophthalmology Product Name: Iluvien
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2022
Details:
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant, injected into back of eye,is designed to release sub-microgram levels of fluocinolone acetonide, a corticosteroid, for 36 months, to reduce recurrence of disease.
Lead Product(s): Fluocinolone Acetonide
Therapeutic Area: Ophthalmology Product Name: Iluvien
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: SIFI
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 08, 2022
Details:
YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg is indicated for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye, and was approved by the FDA.
Lead Product(s): Fluocinolone Acetonide
Therapeutic Area: Ophthalmology Product Name: Yutiq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: OcuMension Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2022
Details:
Iluvien (fluocinolone acetonide intravitreal implant), is designed to release sub-microgram levels, a corticosteroid, for 36 months, to reduce recurrence of disease and number of treatments required, enabling patients to maintain vision longer with fewer injections.
Lead Product(s): Fluocinolone Acetonide
Therapeutic Area: Ophthalmology Product Name: Iluvien
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2022
Details:
ILUVIEN (fluocinolone acetonide), sustained release intravitreal implant, demonstrated statistically significant improvements in best-corrected visual acuity, central subfield thickness, also resulted in a 70.5% reduction in treatment burden at 36 months in PALADIN Study.
Lead Product(s): Fluocinolone Acetonide
Therapeutic Area: Ophthalmology Product Name: Iluvien
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2022
Details:
The real-world data from the Phase 4 PALADIN study show that patients receiving one or less total injections per year for their DME after the ILUVIEN injection increased three-fold from prior to the ILUVIEN injection.
Lead Product(s): Fluocinolone Acetonide
Therapeutic Area: Ophthalmology Product Name: Iluvien
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2021
Details:
ILUVIEN is now available in Finland for diabetic macular edema (DME) and non-infectious uveitis affecting the posterior segment (NIPU), and will be marketed by Alimera and distributed by Nordic Prime.
Lead Product(s): Fluocinolone Acetonide
Therapeutic Area: Ophthalmology Product Name: Iluvien
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 18, 2021
Details:
This investment underscores eyepoints' continued strong partnership with Ocumension for YUTIQ and DEXYCU in Asia. The companies in collaboration, are conducting Phase 1 trial of EYP-1901 in wet age-related macular degeneration.
Lead Product(s): Fluocinolone Acetonide
Therapeutic Area: Ophthalmology Product Name: Yutiq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: OcuMension Therapeutics
Deal Size: $15.7 million Upfront Cash: Undisclosed
Deal Type: Financing January 03, 2021
Details:
The transaction with SWK allows EyePoint to reduce existing debt and interest obligations and improve its balance sheet in advancing its ocular disease pipeline, including EYP-1901 for wet age-related macular degeneration.
Lead Product(s): Fluocinolone Acetonide
Therapeutic Area: Ophthalmology Product Name: Iluvien
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: SWK Holdings Corporation
Deal Size: $16.5 million Upfront Cash: Undisclosed
Deal Type: Agreement December 18, 2020
Details:
Second Ph3 trial of YUTIQ confirms 36-month positive efficacy results from the first Ph3 trial. Study of DEXYCU vs. Prednisolone eye drops shows high patient preference for DEXYCU with statistically better inflammation control, pain, visual acuity outcomes in DEXYCU group.
Lead Product(s): Fluocinolone Acetonide
Therapeutic Area: Ophthalmology Product Name: Yutiq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2020