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Travoprost XR Phase 2 Data Shows 9-Month Duration Of Action After A Single Dose in Glaucoma Patients
Envisia Therapeutics released an interim analysis of its ENV515 (travoprost XR) phase 2 trial in glaucoma patients showing clinically meaningful reduction in IOP for the entire 9-month evaluation period following a single administration. ENV515 also demonstrated an IOP-lowering effect comparable to prestudy topical prostaglandin analogs (XALATAN and LUMIGAN) and in-study topical timolol maleate 0.5% ophthalmic solution (daily eye drops). Glaucoma is the leading cause of preventable vision loss and blindness due largely in part to poor patient compliance with once-daily eye drops.
“ENV515 continues to show great potential with a favorable safety profile and a sustained, clinically meaningful reduction in IOP over the initial 9 months,” Benjamin Yerxa, President of Envisia, said in a news release.”We plan to initiate enrollment in a new cohort of this phase 2 trial by year-end, which will enable us to evaluate the high dosage form of ENV515 that has been formulated with the goal of achieving efficacy comparable to TRAVATAN Z with a duration greater than 9 months.”
The ongoing phase 2 trial is a 12-month safety and efficacy evaluation that enrolled five glaucoma patients at sites within the United States. The pre-washout baseline for all patients in this cohort, treated with LUMIGAN or XALATAN prior to enrollment, was 19.7 mmHg, with a post-washout baseline of 26.1 mmHg for 8 AM IOP. Single low dose of ENV515 decreased the mean + SD 8 AM IOP by 6.7 ± 3.8 mmHg or 26 percent over nine months (mean of all 8 AM IOPs over nine months). The mean 8 AM IOP after a single low dose of ENV515 was 19.4 mmHg over the nine-month period. ENV515 was well tolerated and there were no serious adverse events, no changes in corneal endothelial cell counts evaluated by an independent reading center, and no changes in corneal thickness. The most common adverse event was early-onset transient hyperemia, or eye redness, related to the dosing procedure.
“These 9-month results are very promising and continue to validate Envisia’s novel extended-delivery approach,” Thomas Walters, MD, the lead investigator for the ENV515 phase 2 trial, said in the news release. “Based on these results, ENV515 has the potential to change the way we treat glaucoma in the majority of our patients and to potentially provide the type of efficacy, safety and compliance that is needed to prevent disease progression.”
AOA Calls for Change, Federal Investigation Following Data Breach
In light of an ongoing data breach affecting optometry, the American Optometric Association (AOA) leadership issued a profession-wide call to action to curb current and future cases of identity theft, while also notifying the nation’s chief law enforcement authority, according to an AOA statement.
As yet another wave of malicious credit card applications keeps the profession reeling, the AOA Board of Trustees passed a motion on October 8 encouraging optometric organizations to take immediate steps to meet recognized standards for data security.
The new resolution calls for a united effort by AOA, affiliates and others, asking each to petition optometric testing organizations, including the National Board of Examiners in Optometry (NBEO), and state boards of optometry to eliminate the use of social security numbers (SSNs) as personal identifiers, in favor of unique identifier numbers, wholly unrelated to SSNs or other sensitive personal information.
While the source of this particular data breach is still unknown, students are preparing to take their board examinations and, to do so, they currently need to provide sensitive information, including SSNs. This requirement is not consistent across health care professions, the release stated.
The Joint Commission on National Dental Examinations, for instance, requires dental students to use a unique identifier—known as a DENTPIN—to access testing resources, instead of an SSN. The American Dental Educators Association states the DENTPIN replaced “Social Security numbers, Canadian Social Insurance Numbers, or Reference Numbers to help protect sensitive, identifying information while facilitating data collection and reporting.”
This AOA Board motion comes two weeks after AOA President Andrea P. Thau, O.D., called on the NBEO to issue privacy reassurances to students and recent graduates that their personal data will be protected. “In order to allay these concerns, can you provide assurances that the current NBEO registration system for new registrants—which includes the required entry of Social Security numbers—comports with best practices for testing bodies in other professions and meets all applicable industry standards for data security?” Dr. Thau questioned.
The AOA has yet to receive a formal reply, but will continue insisting on the latest, most accurate information to provide to its members. The AOA encourages all doctors of optometry—not only students and new graduates—to initiate credit monitoring, as all signs point to profession-wide involvement. Click here to learn more about protecting your identity, even if you haven’t been affected by this particular breach.
Optometry deserves to know the source of this breach and be assured that steps are being taken to eliminate the chance of this occurring again, the AOA stated. The AOA is taking those steps, not only by calling on testing organizations and state boards, but also by reaching out to federal investigators.
Following initial reports of unsolicited, fraudulent applications for Chase Amazon.com Visa cards on and around August 2, the AOA contacted the FBI and Federal Trade Commission to apprise investigators. Now, AOA’s leadership has taken another step. At the direction of AOA’s Board of Trustees, the AOA also drafted a letter to the U.S. Attorney General’s Office that calls for further Department of Justice investigation into the identity thefts currently affecting untold numbers in optometry.
As stated in the letter (http://www.aoa.org/documents/secure/advocacy/aoa_lynch_stokes_letter_101316.pdf), the AOA hopes that by holding those responsible accountable, and reforming state licensing and testing requirements to address privacy concerns, “the profession may begin to put this episode behind it and reduce the likelihood of any similar occurrence in the future.” The letter continues: “The AOA respectfully requests the Department of Justice, acting through the FBI, pursue an investigation to identify the data thieves responsible for this criminal act.”
The AOA reiterates that no breach of AOA’s systems occurred, and furthermore, AOA does not gather SSNs through its membership process. The AOA continues to follow this situation closely and will provide updates when possible.
Sensimed Enters into Collaboration, Financing Agreement With SEED
Sensimed announced the expansion of its current collaboration in Japan with SEED, a Japanese contact lens manufacturer. The agreement enables the companies to combine efforts to work to obtain registration of the SENSIMED Triggerfish, according to a company news release. Following approval and agreement with PMDA, the companies will then work to conduct key pivotal clinical activities in Japan. A CHF 10M financing was completed through a convertible loan to support the registration in Japan and to further validate unique diagnostic and predictive clinical claims for the technology. SEED contributed half of these funds with current investors matching this amount.
Sensimed AG, a Swiss company, has developed a unique noninvasive soft contact lens-based solution, the Sensimed Triggerfish, with the aim of revolutionizing glaucoma management by providing an automated recording of continuous ocular dimensional changes over 24 hours. The contact lens itself is very well tolerated over the measurement period and uses telemetry in combination with a fully integrated sensor to measure volumetric changes of the eye. To date, Sensimed has published over 35 peer review articles in major ophthalmic journals to support these conclusions. The Sensimed Triggerfish is a platform technology which obtained a “first of a kind” FDA approval in March of 2016 and which can be used to support alternative sensors focused on other clinical measurement applications.
“We are very pleased to expand our partnership with SEED who have a solid organization to support the registration of our Smart Contact Lens technology in Japan,” David Bailey, CEO of Sensimed, said in the news release.
Assuming agreement with PMDA and after formal approval of the technology the two companies intend to accumulate clinical data from specialized medical centers. In Japan, these efforts will be directed toward the large number of patients who have normal tension glaucoma where standard IOP measurement tools are inadequate and where there is a large unmet need for an additional diagnostic indicator. The 24 hour profiles provided by the Sensimed Triggerfish device will be analyzed and modeled to fully categorize the disease state and aid personalized treatment.
“The prevalence of normal tension glaucoma in Asia presents an additional challenge for doctors in managing their glaucoma patients. In this situation, standard tonometry alone can often lead to misdiagnosis and delayed treatment. This study is aimed at providing highly valuable information on the behavior of the eye during 24 hours in order to better categorize and diagnose this dominant group of NTG patients” said Mr. Bailey.
“Sensimed is pleased to partner with SEED to work toward obtaining such a break through approval in Japan. We are also delighted that SEED chose to become a shareholder in Sensimed by joining current investors to complete the 10MCHF convertible instrument to fund these efforts” added Mr. Bailey.