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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): 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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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 July 23, 2020
Details:
First Coast Service Options became the second MAC to establish a physician fee schedule for procedure code 0356T for the administration of drug-eluting intracanalicular inserts, including DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg, effective July 1, 2020.
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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 July 17, 2020
Details:
Despite the ongoing market challenges amid COVID, the Company had its strongest month to date in DEXTENZA in-market sales in June as Ambulatory Surgery Centers (ASCs) and hospital outpatient departments purchased 2,294 billable inserts.
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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 July 09, 2020
Details:
U.S FDA has approved Upneeq (oxymetazoline hydrochloride ophthalmic solution), 0.1%, formerly known as RVL-1201, its novel treatment for acquired blepharoptosis, or ptosis, a condition characterized by the abnormal drooping of the upper eyelid that can limit field of vision.
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Lead Product(s): Hypochlorous Acid
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Brill International S.L
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 26, 2020
Details:
Sonoma has agreed on a 10-year license, distribution and supply agreement with its distribution partner Brill International S.L. to market the eye care product under the private label Ocudox™ in the European markets of Italy, Germany, Spain, Portugal and the United Kingdom.
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Lead Product(s): Netarsudil Mesylate
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 April 09, 2020
Details:
Aerie expects to hold a meeting with the regulatory authorities in Japan during to discuss Phase 3 trial designs for Rhopressa® while continuing to explore partnership opportunities.
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