Triols

Nicox’s Licensee Bausch + Lomb Receives Approval for VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% in the United Arab Emirates

Retrieved on: 
Friday, June 25, 2021

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that its exclusive global licensee Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., has received approval for VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% in the United Arab Emirates.

Key Points: 
  • Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that its exclusive global licensee Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., has received approval for VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% in the United Arab Emirates.
  • Now approved in 12 countries, VYZULTA is commercialized in the United States (since 2017), Canada (2019), Argentina (2020), Mexico (2020), Hong Kong (2020) and Taiwan (2021).
  • It is also approved in Brazil, Colombia, Qatar, South Korea, Ukraine and the United Arab Emirates.
  • VYZULTA is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension in the United States and other territories that have the same indication.

Crude Glycerine Market Size Worth $1.26 Billion By 2028 | CAGR: 8.1%: Polaris Market Research

Retrieved on: 
Monday, April 26, 2021

b'NEW YORK, April 26, 2021 /PRNewswire/ -- The global crude glycerine market size is expected to reach USD 1.26 billion by 2028 according to a new study conducted by Polaris Market Research.

Key Points: 
  • b'NEW YORK, April 26, 2021 /PRNewswire/ -- The global crude glycerine market size is expected to reach USD 1.26 billion by 2028 according to a new study conducted by Polaris Market Research.
  • the market isanticipated to register a CAGR of 8.1% from2021 2028.
  • Increasing industrialization globally and a rise in demand from wastewater treatment is anticipated to create lucrative opportunities in the crude glycerine market.
  • Feel Free To Ask Our Industry Experts At : https://www.polarismarketresearch.com/industry-analysis/crude-glycerine-...\nPolaris Market Research has segmented the crude glycerine market report on the basis of glycerol content, application, region:\nCrude Glycerine Glycerol Content Outlook (Revenue, USD Million, 2016 2028)\n'

Nicox’s NCX 470 Mont Blanc Phase 3 Glaucoma Trial Reaches 50% Enrollment Milestone

Retrieved on: 
Tuesday, March 23, 2021

Mont Blanc is a 3-month multi-regional Phase 3 clinical trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1% versus latanoprost ophthalmic solution, 0.005%, for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Key Points: 
  • Mont Blanc is a 3-month multi-regional Phase 3 clinical trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1% versus latanoprost ophthalmic solution, 0.005%, for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
  • The Mont Blanc trial was initiated in the U.S. in June 2020 with an initial adaptive design portion wherein the highest dose of NCX 470 tested in the Dolomites Phase 2 clinical trial, 0.065%, was evaluated together with a higher 0.1% concentration of NCX 470.
  • The 0.1% dose of NCX 470 was selected in the adaptive stage of the Mont Blanc trial and enabled the second part of the Mont Blanc Phase 3 trial and the start of Denali Phase 3 trial.
  • Nicoxs lead program in clinical development is NCX 470, a novel nitric oxide-donating prostaglandin analog, for lowering intraocular pressure in patients with glaucoma.

Nicox’s NCX 470 Receives Approval by Chinese Authorities for Local Start of Denali Phase 3 Trial

Retrieved on: 
Thursday, March 4, 2021

Nicoxs lead clinical product candidate, NCX 470, is a novel nitric oxide (NO)-donating prostaglandin analog licensed exclusively to Ocumension Therapeutics for the Chinese, Korean and South East Asian markets.

Key Points: 
  • Nicoxs lead clinical product candidate, NCX 470, is a novel nitric oxide (NO)-donating prostaglandin analog licensed exclusively to Ocumension Therapeutics for the Chinese, Korean and South East Asian markets.
  • Dr. Jos Boyer, Interim Head of R&D at Nicox, said: This approval allows us to initiate Chinese patients in the Denali trial on schedule.
  • Denali, the second Phase 3 trial of NCX 470 for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension, was initiated in the U.S. on November 9, 2020.
  • Denali is a 3-month trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1% versus latanoprost ophthalmic solution, 0.005% and will also include a long-term safety extension.

Bausch Health Announces Vyzulta® (latanoprostene Bunod Ophthalmic Solution), 0.024%, is Now Approved in South Korea

Retrieved on: 
Tuesday, February 9, 2021

Bausch + Lomb remains focused on bringing forward innovative eye health treatment options to help address unmet medical needs around the world.

Key Points: 
  • Bausch + Lomb remains focused on bringing forward innovative eye health treatment options to help address unmet medical needs around the world.
  • VYZULTA is now approved in nine markets, including Argentina, Canada, Colombia, Hong Kong, Mexico, South Korea, Taiwan, Ukraine and the United States.
  • VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
  • Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., is solely focused on helping people see.

Glaukos’ iDose® TR Demonstrates Sustained IOP Reduction and Favorable Safety Profile Over 24 Months in Phase 2b Study

Retrieved on: 
Wednesday, January 13, 2021

Once all travoprost is released, the iDose TR was designed to be removed and replaced with a new iDose TR, thus offering an alternative to daily eye drop treatment.

Key Points: 
  • Once all travoprost is released, the iDose TR was designed to be removed and replaced with a new iDose TR, thus offering an alternative to daily eye drop treatment.
  • All IOP analyses were calculated using all IOP observations over 24 months weighted equally with no imputations for protocol-mandated medications.
  • Subjects who had been on a single pre-study IOP-lowering medication at the screening visit had greater average IOP reduction over 24 months on iDose TR versus the pre-study IOP-lowering eye drops.
  • The 12-month iDose TR Phase 3 trial results are expected to support Glaukos NDA submission in 2022 and the company is now targeting FDA approval for iDose TR in 2023.

Nicox’s Licensee Bausch + Lomb Launches VYZULTA in Mexico

Retrieved on: 
Wednesday, January 6, 2021

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that an affiliate of its licensee, Bausch + Lomb, has launched VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% in Mexico.

Key Points: 
  • Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that an affiliate of its licensee, Bausch + Lomb, has launched VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% in Mexico.
  • First approved by the U.S. Food and Drug Administration in late 2017, VYZULTA is now commercialized in the United States, Canada, Argentina and Mexico.
  • Under the terms of the exclusive license agreement with Bausch + Lomb, Nicox receives increasing tiered royalties of 6% to 12% on net global sales of VYZULTA plus up to $150 million in potential future milestones payments.
  • Nicoxs lead program in clinical development is NCX 470, a novel, second-generation nitric oxide-donating prostaglandin analog, for lowering intraocular pressure in patients with glaucoma.

Aerpio Announces Statistically Significant Topline Results from Razuprotafib Glaucoma Phase 2 Trial

Retrieved on: 
Friday, December 11, 2020

The razuprotafib once-daily (QD) dose group did not show a statistically significant improvement at Day 28.

Key Points: 
  • The razuprotafib once-daily (QD) dose group did not show a statistically significant improvement at Day 28.
  • The study was designed to evaluate the safety and efficacy of a topical ocular formulation of razuprotafib as an adjunct to standard of care latanoprost.
  • The primary endpoint of the study was mean diurnal IOP at 28 days in the razuprotafib treated groups compared to the latanoprost monotherapy group.
  • Aerpio is studying a topical ocular formulation of razuprotafib in open angle glaucoma and exploring the utility of subcutaneous razuprotafib for diabetic complications, including diabetic nephropathy.

Information update - LEO Pharma Inc. is withdrawing the drug Picato (Ingenol mebutate), used to treat skin lesions, due to the potential increased risk of skin cancer

Retrieved on: 
Tuesday, October 27, 2020

What to do: Stop your treatment and talk to your healthcare professional about other treatment options.

Key Points: 
  • What to do: Stop your treatment and talk to your healthcare professional about other treatment options.
  • Monitor your skin for signs or symptoms of skin cancer.
  • At Health Canada's request, LEO Pharma Inc. is withdrawing Picato from the Canadian market.
  • On October 26, 2020, LEO Pharma Inc. initiated the recall of Picato from the Canadian market.

Nicox’s NCX 470 Receives Approval by Chinese Authorities for Local Start of Mont Blanc Phase 3 Trial

Retrieved on: 
Monday, October 26, 2020

NCX 470 development remains on track, with first results from the Mont Blanc trial expected in Q4 2021.

Key Points: 
  • NCX 470 development remains on track, with first results from the Mont Blanc trial expected in Q4 2021.
  • Initiation of Chinese sites in this trial will be essential in preparing the way for Denali, the second Phase 3 trial with NCX 470, which will include a larger number of Chinese patients.
  • The NCX 470 Mont Blanc Phase 3 clinical trial is a 3-month trial to evaluate the safety and efficacy of NCX 470 ophthalmic solution, 0.1%, versus the current standard of care, latanoprost ophthalmic solution, 0.005%, for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension.
  • The Mont Blanc trial was initiated in the U.S. in June 2020 and top-line results are currently expected in Q4 2021.