All Data
Lead Product(s): Olopatadine Hydrochloride
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 September 17, 2020
Details:
Dr. Reddy’s has launched of over-the-counter Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% and 0.1%, the storebrand equivalents of Pataday® Once Daily Relief and Pataday® Twice Daily Relief, in the U.S. market, as approved by the USFDA.
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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: Agreement November 26, 2020
Details:
Dompé farmaceutici and FarmaMondo have inked Managed Access Program distribution agreement appointing the FarmaMondo as the exclusive partner to make Oxervate™ (Cenegermin) available for patients affected by Neurotrophic Keratitis in Russia and other CIS countries.
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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): Brolucizumab
Therapeutic Area: Ophthalmology Product Name: Beovu
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 13, 2020
Details:
Analyses of US real-world and Phase III data presented at the American Academy of Ophthalmology (AAO) 2020 Meeting reported baseline patient characteristics potentially linked with incidence of inflammation-related adverse events that may occur following treatment with Beovu.
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Lead Product(s): Sodium Hyaluronate
Therapeutic Area: Ophthalmology Product Name: LO2A
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 12, 2020
Details:
LOA2 met its primary endpoint of non-inferiority vs. comparator at the 3-month time point in corneal staining with a p value of 0.001. LO2A continued, as in prior trials, to demonstrate a good safety profile with no major adverse events or side effects reported.
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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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