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Details:
In the VIRGO trial evaluating twice-daily administration of VUITY (pilocarpine HCl ophthalmic solution), the primary endpoint of improving near vision without compromising distance vision at Day 14, Hour 9 was met.
Lead Product(s): Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Vuity
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2022
EMWA 2024
Not Confirmed
Contact SupplierDetails:
FDA approval of VUITY (Pilocarpine), is a once-daily prescription eye drop that improves near and intermediate vision without impacting distance vision for adults with age-related blurry near vision.
Lead Product(s): Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Vuity
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2021
EMWA 2024
Not Confirmed
Contact SupplierDetails:
VUITY, an optimized formulation of pilocarpine, established eye care therapeutic, specifically designed to treat age-related blurry near vision. It is delivered with proprietary pHast™ technology, which allows VUITY to rapidly adjust to physiologic pH of the tear film.
Lead Product(s): Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Vuity
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2022
EMWA 2024
Not Confirmed
Contact SupplierDetails:
VUITY is an optimized formulation of pilocarpine, an established eye care therapeutic, specifically designed to treat age-related blurry near vision. It is delivered with proprietary pHas technology, which allows VUITY to rapidly adjust to physiologic pH of the tear film.
Lead Product(s): Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Vuity
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2022
EMWA 2024
Not Confirmed
Contact SupplierDetails:
VUITY™ (pilocarpine HCL ophthalmic solution) 1.25% is a prescription eyedrop to treat age-related blurry near vision (presbyopia) in adults. VUITY to improve near and intermediate vision without impacting distance vision with one drop daily.
Lead Product(s): Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Vuity
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 29, 2021
EMWA 2024
Not Confirmed
Contact SupplierDetails:
The company will present patient-reported outcomes for AGN-190584, an investigational therapy for the treatment of presbyopia. Recently the company submitted an NDA to the U.S. Food and Drug Administration based on data from the Phase 3 GEMINI 1 and GEMINI 2 clinical trials.
Lead Product(s): Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: AGN-190584
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: AbbVie Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2021
EMWA 2024
Not Confirmed
Contact SupplierDetails:
Allergan has submitted a New Drug Application to the U.S. Food and Drug Administration for investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. The FDA is expected to act on the NDA by the end of 2021.
Lead Product(s): Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: AGN-190584
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: AbbVie Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2021
EMWA 2024
Not Confirmed
Contact SupplierDetails:
Data presented at the meeting will include an analysis examining the safety and efficacy of DURYSTA™ and a second analysis of data from the Phase 3 ARTEMIS studies that identify different characteristics of glaucoma patients who may respond after being treated with DURYSTA™.
Lead Product(s): Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: AGN-190584
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 06, 2020
EMWA 2024
Not Confirmed
Contact SupplierDetails:
Phase 3 GEMINI 1 and 2 studies evaluating AGN-190584 (pilocarpine 1.25%) ophthalmic solution met the primary endpoint, reaching statistical significance in improvement in near vision.
Lead Product(s): Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: AGN-190584
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: AbbVie Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2020
EMWA 2024
Not Confirmed
Contact SupplierDetails:
CSF-1 is a preservative-free formulation of low-dose pilocarpine, a muscarinic cholinergic agonist used on the eye to treat elevated intraocular pressure, various types of glaucoma, and to induce miosis. It is being investigated for the treatment of presbyopia.
Lead Product(s): Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: CSF-1
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 21, 2023
Details:
Pilocarpine is a muscarinic cholinergic agonist used on the eye to treat elevated intraocular pressure, various types of glaucoma, and to induce miosis. Also available orally to treat symptoms of dry mouth associated with Sjogren's syndrome and radiotherapy.
Lead Product(s): Pilocarpine Hydrochloride
Therapeutic Area: Dental and Oral Health Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2023
Details:
Nyxol® is a preservative-free ophthalmic solution containing 0.75% phentolamine (or 1% phentolamine mesylate), a nonselective alpha adrenergic antagonist that inhibits the contraction of smooth muscle of the iris.
Lead Product(s): Phentolamine Mesylate,Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 09, 2023
Details:
Nyxol® eye drops (0.75% phentolamine ophthalmic solution), is once-daily, preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size.
Lead Product(s): Phentolamine Mesylate,Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2022
Details:
ARVN003 (pilocarpine microdose ophthalmic solution/Microline), a proprietary formulation based on microdosing platform Optejet® for the pharmacologic treatment for presbyopia.
Lead Product(s): Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: MicroLine
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eyenovia
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2022
Details:
Two presentations on Phase 2b clinical trial show CSF-1 met primary endpoints and achieved statistically significant and clinically meaningful improvements in distance-corrected near visual acuity (DCNVA) for participants with presbyopia.
Lead Product(s): Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: CSF-1
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2022
Details:
ARVN003 is a pharmacologic treatment for presbyopia. The product is developed based on Optejet, a proprietary micro-dosing administration device utilizing MAP technology, and pilocapine, the well-established ophthalmic medicine for temporary improvement of near vision.
Lead Product(s): Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: MicroLine
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eyenovia
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2021
Details:
Nyxol® (0.75% phentolamine ophthalmic solution) Eye Drops, is a once-daily preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size, and is being developed for several indications.
Lead Product(s): Phentolamine Mesylate,Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2021
Details:
61% of subjects treated with Nyxol + LDP improved 15 letters or greater (≥ 3 lines) in photopic binocular near vision at 1 hour compared with 28% of subjects on placebo with statistical significance.
Lead Product(s): Phentolamine Mesylate,Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2021
Details:
Eyenovia previously announced initial topline data from its Phase 3 VISION-1 clinical trial, which evaluated the company’s proprietary pilocarpine solution, administered via the Optejet®, for the treatment of presbyopia.
Lead Product(s): Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: MicroLine
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2021
Details:
The VEGA-1 clinical trial is designed to evaluate the efficacy and safety of Nyxol in combination with low-dose pilocarpine compared to placebo in presbyopic subjects.
Lead Product(s): Phentolamine Mesylate,Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2021
Details:
Nyxol alone in multiple Phase 2 trials has reduced pupil diameter by approximately 20% and has significantly improved near visual acuity by one eye-chart line for over 24 hours after an evening eye drop.
Lead Product(s): Phentolamine Mesylate,Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 18, 2021
Details:
The offering are expected to be used for the MicroLine and MicroPine clinical studies, to advance MicroStat’s new drug application, and for working capital & general corporate purposes.
Lead Product(s): Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Securities Corporation
Deal Size: $6.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement March 24, 2020
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