Antibiotic Eye Ointments: Uses, Side Effects, Dosages
Implant For Ocular Hypertension, Glaucoma Gets FDA Green Light
The FDA approved the travoprost intracameral implant (iDose TR) for treatment of ocular hypertension and glaucoma, device developer Glaukos announced on Thursday.
The implant is designed to provide long-duration treatment for the "full range of glaucoma disease severity," according to a statement from the company. The implant releases the prostaglandin analog travoprost, which is already approved for the two ocular conditions.
"With the next generation of procedural pharmaceutical solutions for glaucoma such as iDose TR, we now have a new tool that will confront the standard legacy practice of relying on topical drops, which are known to cause uncomfortable side effects and present a myriad of challenges such as treatment adherence, complex dosing regimens, and difficulty with self-administration," said John Berdahl, MD, of Vance Thompson Vision, in Sioux Falls, South Dakota, in the Glaukos statement. "The clinical data suggest that iDose TR is not only effective with a favorable safety profile, but it has potential to relieve patients from the burdens of prescription eye drops for an extended period of time."
Primary support for the approval came from two phase III randomized trials that demonstrated noninferiority versus timolol eye drops. Patients randomized to the implant had a decrease in intraocular pressure (IOP) from baseline (mean 24 mm Hg) to 90 days: by 6.6-8.5 mm Hg in one trial and 6.7-8.4 mm Hg in the second. The timolol eye drops achieved reductions of 6.6-7.7 mm Hg and 6.8-7.2 mm Hg in the trials.
During a presentation at the American Society of Cataract and Refractive Surgery meeting, Berdahl said that 90% of the implant group had well-controlled IOP at 12 months as compared with 67% of the timolol group. The device had a favorable safety profile, including low rates of conjunctival hyperemia, no corneal endothelial cell loss, no serious corneal adverse events, and no adverse events of periorbital fat atrophy. The implant could be exchanged without evidence of significant endothelial cell loss.
According to the company statement, a single administration of the implant has maintained IOP control for as long as 36 months. The company intends to begin sales of the implant during the first quarter of 2024 at an estimated wholesale acquisition cost of $13,950 per implant.
Charles Bankhead is senior editor for oncology and also covers urology, dermatology, and ophthalmology. He joined MedPage Today in 2007. Follow
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Ocular Hypertension Market Size Expected To Reach US$ 4,446.4 Million By 2033IMARC Group
(MENAFN- EIN Presswire)
HOUSTON, ALABAMA, USA, December 26, 2023 /EINPresswire / -- Market Overview:
The ocular hypertension market reached a value of US$ 2,941.6 Million in 2022 and expects to reach US$ 4,446.4 Million by 2033, exhibiting a growth rate (CAGR) of 3.82% during 2023-2033.
The ocular hypertension market report offers a comprehensive analysis of the market in the United States, EU5 (including Germany, Spain, Italy, France, and the United Kingdom), and Japan. It covers aspects such as treatment methods, drugs available in the market, drugs in development, the market share of various therapies, and the market's performance in the seven major regions. Additionally, the report evaluates the performance of leading companies and their pharmaceutical products. Current and projected patient numbers across these key markets are also detailed in the report. This study is essential for manufacturers, investors, business planners, researchers, consultants, and anyone interested or involved in the ocular hypertension market.
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Ocular Hypertension Market Trends:
Ocular hypertension is characterized by higher-than-normal intraocular pressure (IOP) in the eye. The ocular hypertension market is experiencing substantial growth, driven by a convergence of factors. Key among these is the increasing prevalence of ocular hypertension and related eye conditions, particularly among the aging population. As individuals age, their susceptibility to eye problems, including glaucoma (where ocular hypertension is a significant risk factor), rises. Consequently, there is an expected surge in demand for diagnostic services and treatment options for ocular hypertension. Additionally, technological advancements in the medical field are contributing significantly to market expansion. Cutting-edge diagnostic tools, such as advanced tonometers and optical coherence tomography, enable earlier and more precise detection of ocular hypertension. Pharmaceutical innovations like prostaglandin analogs are providing advanced and minimally invasive therapies, driving their adoption among both healthcare providers and patients. Efforts to increase awareness are also pivotal for market growth. Healthcare organizations and institutions are actively engaged in raising awareness about the importance of regular eye examinations and early detection. These initiatives serve to educate the public while promoting preventive care, thereby increasing the demand for diagnostic services and medications.
Furthermore, strategic partnerships and financial investments by major market players are contributing to the market's dynamism. Companies are proactively collaborating with academic institutions and other enterprises to accelerate drug discovery and enhance existing treatment options. These collaborative endeavors often merge academic research with business expertise, propelling the market forward. Lastly, supportive government regulations, including subsidies for eye care and reimbursement policies, are expected to further stimulate the ocular hypertension market in the near future. These regulatory measures enhance patient access to necessary treatments and services, fostering market growth.
Countries Covered:
. United States. Germany. France. United Kingdom. Italy. Spain. Japan
Analysis Covered Across Each Country:
. Historical, current, and future epidemiology scenario. Historical, current, and future performance of the ocular hypertension market. Historical, current, and future performance of various therapeutic categories in the market. Sales of various drugs across the ocular hypertension market. Reimbursement scenario in the market. In-market and pipeline drugs
This report also provides a detailed analysis of the current ocular hypertension market drugs and late-stage pipeline drugs.
In-Market Drugs:
. Drug Overview. Mechanism of Action. Regulatory Status. Clinical Trial Results. Drug Uptake and Market Performance
Late-Stage Pipeline Drugs:
. Drug overview. Mechanism of action. Regulatory status. Clinical trial results. Drug uptake and market performance
Competitive Landscape With Key Players:
The competitive landscape of the ocular hypertension market has been studied in the report with the detailed profiles of the key players operating in the market.
Some of the Key Players:
Alcon
AbbVie
Bausch & Lomb
R-Tech Ueno Ltd
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If you need specific information that is not currently within the scope of the report, we will provide it to you as a part of the customization.
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Glaucoma & Ocular Hypertension More Likely In Patients With Refractive Errors
A study which appeared in the clinical journal of Ophthalmology concludes that farsightedness appears to be associated with a five-year risk of ocular hypertension, and nearsightedness is associated with a significantly increased prevalence of glaucoma, in Caucasians. The study was conducted with nearly 5000 participants, aged between 43 to 84, who received baseline assessments of refractive error (nearsightedness and farsightedness), intraocular pressure and glaucoma, and five-year follow-up measurements of intraocular pressure and ocular hypertension.Researchers found that farsighted participants were 40 percent more likely to have incident ocular hypertension than those without refractive error. Incident ocular hypertension is high intraocular pressure with no apparent damage to the optic nerve and visual field defects that characterize glaucoma, though glaucoma may develop with time. The study also found nearsighted participants were 60 percent more likely to have glaucoma than those without refractive error. The researchers who noted that farsightedness has been associated with primary angle-closure glaucoma, say that the shallower front chamber of the eye may predispose a person to higher intraocular pressure. They also say it is possible farsightedness "may simply be a marker for biologic aging". However, they added that they do not have adequate explanation for the association and that further research is needed.
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Andrew Iwach, M.D. Concluded that people need to get comprehensive, dilated eye exams to determine if they are at risk for glaucoma or ocular hypertension, what their exam frequency should be, and whether they require individualized management plans, instead of just refractive eye exams for glasses or contacts.
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