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Lead Product(s): Fluocinolone Acetonide
Therapeutic Area: Ophthalmology Product Name: Yutiq
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 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.
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Lead Product(s): Netarsudil Mesylate,Latanoprost
Therapeutic Area: Ophthalmology Product Name: Roclanda
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 13, 2020
Details:
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of the marketing authorisation application (MAA) for Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%.
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Lead Product(s): Dexamethasone
Therapeutic Area: Ophthalmology Product Name: Dextenza
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: AffaMed Therapeutics
Deal Size: $103.0 million Upfront Cash: $12.0 million
Deal Type: Licensing Agreement October 30, 2020
Details:
AffaMed has received rights to develop and market DEXTENZA to reduce post-surgical inflammation and pain and ocular itching in patients with allergic conjunctivitis, and OTX-TIC t reduce high intraocular pressure in ocular hypertension in Greater China, South Korea and Asia.
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Lead Product(s): Netarsudil
Therapeutic Area: Ophthalmology Product Name: Rhopressa
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Santen Pharmaceutical
Deal Size: $149.0 million Upfront Cash: $50.0 million
Deal Type: Licensing Agreement October 28, 2020
Details:
Santen will look after sales, marketing and pricing decisions relating to Rhopressa® and Rocklatan®. Aerie and Santen will collaborate for the first Phase 3 study for Rhopressa® in Japan.
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Lead Product(s): Loteprednol Etabonate
Therapeutic Area: Ophthalmology Product Name: Eysuvis
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2020
Details:
The FDA granted approval to EYSUVIS based on results from four clinical trials, including three Phase 3 trials and one Phase 2 trial, that demonstrated significant improvements in both the signs and symptoms of dry eye disease.
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Lead Product(s): Atropine Sulfate
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2020
Details:
U.S FDA has approved the Company’s Abbreviated New Drug Application (“ANDA”) for Atropine Sulfate injection 0.1mg/mL in the 10 mL Luer-Jet® Prefilled Syringe System.
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Lead Product(s): Oxymetazoline
Therapeutic Area: Ophthalmology Product Name: Upneeq
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 01, 2020
Details:
Phase 3 trials showed UPNEEQ was associated with positive outcomes after instillation on days 1 and 14 and was well-tolerated, demonstrating its potential promise for the treatment of acquired ptosis.
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Lead Product(s): Netarsudil Mesylate,Latanoprost
Therapeutic Area: Ophthalmology Product Name: Roclanda
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 24, 2020
Details:
Aerie Pharmaceuticals successful interim 90-day topline data from its six-month Phase 3b clinical trial in Europe known as Mercury 3, comparing Roclanda® to Ganfort®.
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Lead Product(s): Dexamethasone
Therapeutic Area: Ophthalmology Product Name: Dextenza
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 10, 2020
Details:
The clinical trial is designed to evaluate the safety and biological activity of DEXTENZA compared to an active control, prednisolone acetate suspension eye drops, for the treatment of postoperative inflammation and pain following ocular surgery for pediatric cataract.
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Lead Product(s): Cenegermin
Therapeutic Area: Ophthalmology Product Name: Oxervate
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Dompe Farmaceutici
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership July 30, 2020
Details:
The agreement names Tanner Pharma Group as the exclusive provider of Oxervate (cenegermin) in countries outside of the United States, Canada, Italy, China and CIS countries (Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, and Uzbekistan).
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