Brimonidine/timolol

Medicare starts a long road to cutting prices for drugs, starting with 10 costing it $50.5 billion annually – a health policy analyst explains why negotiations are promising but will take years

Retrieved on: 
Thursday, August 31, 2023

The drugs are purchased through Medicare Part D, a prescription drug coverage program for Americans ages 65 and older.

Key Points: 
  • The drugs are purchased through Medicare Part D, a prescription drug coverage program for Americans ages 65 and older.
  • The 10 medications accounted for more than US$50.5 billion in gross costs between June 1, 2022, and May 31, 2023.
  • Pending successful negotiations, these changes would amount to what researchers estimated to be net savings of about $1.8 billion in 2026.
  • Negotiations are expected to begin in October and continue until August 2024, with lower prices going into effect in 2026.

Cutting drug costs for Medicare enrollees

    • The Inflation Reduction Act allows the Centers for Medicare & Medicaid Services to negotiate prices with the companies that make some of the most expensive drugs in the Medicare program, including life-saving cancer and diabetes treatments like Imbruvica and Januvia.
    • The Biden administration hopes that these cost savings will be passed down to Americans 65 and older through reduced Medicare Part D premiums and lower out-of-pocket costs.
    • The Inflation Reduction Act also includes a separate provision that requires drugmakers, under certain conditions, to provide the Medicare program with rebates if drug price increases outpace inflation, starting in January of 2023.

Penalties for companies that won’t negotiate

    • Pharmaceutical companies have to sign agreements to participate in the upcoming negotiations by October 2023.
    • If drugmakers don’t negotiate, they will face stiff penalties in the form of a tax, reaching as high as 95% of U.S. pharmaceutical product sales.
    • Alternatively, the companies may pull their drugs from the Medicare and Medicaid markets, meaning that seniors on Medicare would lose access to them.

Why US drug prices are so high

    • While Americans spent more than $1,100 a year in 2019, Germans paid $825, the British paid $285 and Australians paid $434 per person.
    • Of course, many other countries also directly set prices for drugs or use their monopoly on health services to drive down costs.
    • For example, Dulera, an asthma drug, costs 50 times more in the U.S. than the international average.
    • Januvia, a diabetes drug that is among the first 10 drugs up for price negotiation, and Combigan, a glaucoma drug, cost about 10 times more.

Strong resistance

    • This is because potential Republican wins in the 2024 presidential and congressional elections could unravel or severely curtail the new drug negotiation policy.
    • Indeed, Republicans have been working feverishly on designing a strategy to use the negotiations against Democrats in the upcoming elections.

Weighing the prospects

    • For now, the effect will likely be small because patients already receive discounts on the listed drugs, bringing the net savings down substantially.
    • However, the potential for real savings for Americans ages 65 and older will undoubtedly grow as more drugs become subject to negotiation.
    • Moreover, drugmakers could also simply pull their drugs from Medicare and Medicaid to force the government’s hand.

Antiglaucoma Drugs Global Market Report 2023

Retrieved on: 
Monday, February 20, 2023

The global antiglaucoma drugs market will grow from $14.02 billion in 2022 to $15.04 billion in 2023 at a compound annual growth rate (CAGR) of 7.3%.

Key Points: 
  • The global antiglaucoma drugs market will grow from $14.02 billion in 2022 to $15.04 billion in 2023 at a compound annual growth rate (CAGR) of 7.3%.
  • The regions covered in the antiglaucoma drugs market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
  • The countries covered in the antiglaucoma drugs market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.
  • The antiglaucoma drug market research report is one of a series of new reports that provides antiglaucoma drug market statistics, including antiglaucoma drug industry global market size, regional shares, competitors with an antiglaucoma drug market share, detailed antiglaucoma drug market segments, market trends and opportunities, and any further data you may need to thrive in the antiglaucoma drug industry.

TearClear Announces Positive Topline Results from CLEAR Phase 3 Study for the Treatment of Glaucoma with TC-002 (latanoprost ophthalmic solution 0.005%)

Retrieved on: 
Thursday, September 29, 2022

CHICAGO, Sept. 29, 2022 (GLOBE NEWSWIRE) -- TearClear, an ophthalmic pharmaceutical company that transforms trusted drugs into branded best-in-class therapies, announced today that the company’s lead product, TC-002 (latanoprost ophthalmic solution 0.005%) met the primary and all secondary endpoints in the CLEAR Phase 3 pivotal trial. With these results, TearClear plans to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) in the first quarter of 2023. Upon approval, TC-002 will offer patients the first and only means of delivering preservative-free doses of latanoprost from conventional multi-dose bottles.

Key Points: 
  • With these results, TearClear plans to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) in the first quarter of 2023.
  • Upon approval, TC-002 will offer patients the first and only means of delivering preservative-free doses of latanoprost from conventional multi-dose bottles.
  • Many patients on preserved glaucoma medications experience moderate to severe signs and symptoms of ocular surface disease (OSD)1.
  • This causes discomfort for patients, frustration for physicians and drives additional costs for payers, said Stuart Raetzman, CEO of TearClear.

Apotex Corp. Launches First-to-Market Authorized Generic Version of Combigan® Ophthalmic Solution in the United States

Retrieved on: 
Wednesday, January 19, 2022

WESTON, Fla., Jan. 19, 2022 /PRNewswire/ - Apotex Corp. launched the authorized generic version of Combigan (Brimonidine Timolol OPSO 0.2%/0.5%) in the United States.

Key Points: 
  • WESTON, Fla., Jan. 19, 2022 /PRNewswire/ - Apotex Corp. launched the authorized generic version of Combigan (Brimonidine Timolol OPSO 0.2%/0.5%) in the United States.
  • Brimonidine Timolol isindicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.
  • "We are proud to provide American patients with cost savings by bringing the first generic version of Combigan to patients, allowing for a low-cost, high-quality solution," said Peter Hardwick, President, Apotex Corp.
  • Apotex Corp. is a US based company, headquartered in Weston, Florida.

Global Glaucoma Market Pipeline Spotlight Report 2021-2031: Key Marketed & Pipeline Drugs, Clinical Trials, Regulations, Probability of Success, Disease Prevalence, Licensing and Acquisition, Revenue - ResearchAndMarkets.com

Retrieved on: 
Tuesday, June 15, 2021

This Market Spotlight report covers the Glaucoma market, comprising key marketed and pipeline drugs, clinical trials, upcoming and regulatory events, probability of success, recent events and analyst opinion, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Points: 
  • This Market Spotlight report covers the Glaucoma market, comprising key marketed and pipeline drugs, clinical trials, upcoming and regulatory events, probability of success, recent events and analyst opinion, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
  • The majority of approved drugs in the glaucoma space target beta adrenergic receptors or the prostaglandin F receptor.
  • The highest proportion of industry-sponsored drugs in active clinical development for glaucoma are in Phase II, with only one drug in the NDA/BLA phase.
  • Novartis leads industry sponsors with by far the highest overall number of clinical trials for glaucoma, followed by AbbVie

Skye Bioscience’s THCVHS Demonstrates Superior Therapeutic Benefit Compared to Glaucoma Standard of Care, both as Combination and Single Agent, in Preclinical Study

Retrieved on: 
Monday, May 17, 2021

More than half of patients eventually require two or more drugs to adequately control their IOP.

Key Points: 
  • More than half of patients eventually require two or more drugs to adequately control their IOP.
  • Clinical evidence suggests that combining different classes of IOP-lowering drugs can provide additional benefit for some patients.
  • \xe2\x80\x9cThese data suggest there is strong potential for THCVHS to be a once-a-day treatment, a desirable outcome for glaucoma treatments.
  • In the combined drug study, the second drug was administered 15 minutes after administering the first drug.

Ocular Therapeutix™ Announces FDA Acceptance of Supplemental New Drug Application for DEXTENZA® (dexamethasone ophthalmic insert) for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis

Retrieved on: 
Thursday, March 4, 2021

If approved, this sNDA would include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA.

Key Points: 
  • If approved, this sNDA would include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA.
  • DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery.
  • Ocular Therapeutixs first commercial drug product, DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery.
  • Ocular Therapeutix has also submitted a Supplemental NDA for DEXTENZA to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication.

Ocular Therapeutix™ Announces Submission to the FDA of a Supplemental New Drug Application for DEXTENZA® (dexamethasone ophthalmic insert) for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis

Retrieved on: 
Tuesday, December 22, 2020

If approved, this sNDA would include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA.

Key Points: 
  • If approved, this sNDA would include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA.
  • We are excited to share the allergic conjunctivitis data with the FDA and feel this sNDA supports an expanded label.
  • Ocular Therapeutixs first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery.
  • Ocular Therapeutix has completed Phase 3 clinical trials evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis.

Ocular Therapeutix Announces Preliminary Net Product Revenue of $5.8 Million to $5.9 Million for Third Quarter 2020, Representing Greater Than a 250% Increase Over the Previous Quarter

Retrieved on: 
Wednesday, October 7, 2020

The Company is reporting preliminary third quarter 2020 total net product revenue of $5.8 to 5.9 million, representing a greater than 250 % sequential increase over the second quarter.

Key Points: 
  • The Company is reporting preliminary third quarter 2020 total net product revenue of $5.8 to 5.9 million, representing a greater than 250 % sequential increase over the second quarter.
  • For the quarter, our end-customers purchased almost 10,000 billable units with nearly half of that total coming in September.
  • Ocular Therapeutixs first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery.
  • Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis.

Ocular Therapeutix™ Announces First Patient Dosed in Phase 3 Clinical Trial of DEXTENZA® for the Treatment of Post-Surgical Ocular Inflammation and Pain in Children

Retrieved on: 
Thursday, September 10, 2020

The Phase 3 clinical trial is a U.S.-based, randomized, multicenter clinical trial that intends to enroll approximately 60 subjects between the ages of 0-3 years.

Key Points: 
  • The Phase 3 clinical trial is a U.S.-based, randomized, multicenter clinical trial that intends to enroll approximately 60 subjects between the ages of 0-3 years.
  • The safety of DEXTENZA was assessed in three Phase 3 clinical trials and a Phase 2 clinical trial.
  • Ocular Therapeutixs first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery.
  • Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis.