Eyenovia: FDA Sends CRL, Reclassifies MydCombi(tm) as Drug-Device Combination Product

 Genus Medical Technologies, LLC v. FDA legal case leads to agency-wide review and reclassification of eye cups, eye droppers, and ophthalmic dispensers

Company received Complete Response Letter with additional requests and is preparing necessary documents for expedited resubmission

 Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that MydCombi, the company’s proprietary, first-in-class combination microdose formulation of tropicamide and phenylephrine for in-office pupil dilation, has been reclassified as a drug-device combination product by the U.S. Food and Drug Administration (FDA) in a Complete Response Letter (CRL) for the company’s new drug application (NDA) received on October 22, 2021.

Eyenovia will provide additional information to the FDA, as requested in the CRL, as soon as possible, including information necessary to meet additional requirements under Genus Medical Technologies, LLC v. FDA. Genus refers to a recent decision by the U.S. Court of Appeals for the District of Columbia Circuit which has resulted in an agency-wide reclassification by FDA of certain drugs to devices or to drug-device combination products. There were no issues raised related to the phase III clinical program for MydCombi.

“While we were surprised by the FDA’s position in the CRL, given our original FDA designation, we understand the unusual situation created by the impact of the Genus case, which compelled an Agency-wide reclassification,” stated Dr. Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia. “Fortunately, we had taken actions throughout the development of MydCombi to minimize the impact of a potential reclassification by the FDA. We are preparing additional documentation requested by the FDA and look forward to resubmitting our NDA in early 2022 for the FDA’s review. Since the device used for MydCombi has commonality with that used in the MicroLine and MicroPine programs, we believe that the information submitted in support of MydCombi will pave the way in advance of those regulatory submissions. In fact, we are on track to initiate our second Phase III MicroLine study for presbyopia in the coming days.”

https://finance.yahoo.com/news/eyenovia-announces-reclassification-mydcombi-tm-120000294.html

Moderna: COVID-19 vaccine protective, safe in young children

 Moderna Inc said on Monday its COVID-19 vaccine generated a strong immune response and was generally well-tolerated in children aged six to 11 years, citing interim data from a study.

The company said it planned to submit the data to U.S., European and other regulators soon.

Moderna said the data showed two 50 microgram doses of the vaccine, half the strength of the doses used in the vaccine given to adults, generated virus-neutralizing antibodies in children.

The majority of side effects were mild or moderate in severity, the company said. The most common solicited adverse events were fatigue, headache, fever and injection site pain.

https://finance.yahoo.com/news/1-moderna-says-covid-19-124309141.html

Guardant Blood-Based Test Accurately Detects Early-Stage Colorectal Cancer

 This study indicates Guardant Health’s blood test could provide meaningful clinical performance in an average risk screening population

Guardant Health, Inc. (Nasdaq: GH), presents data at the American College of Gastroenterology Annual Scientific Meeting being held from October 22-27, showing its LUNAR-2 blood test, which has been developed to screen average-risk patients for colorectal cancer (CRC), offers optimized sensitivity and specificity in identifying those with early-stage CRC. This study was selected by the ACG Abstract Selection Committee as the recipient of the International Award.

In the study, researchers evaluated the LUNAR-2 test in a cohort of 699 patients with early-stage (Stage 1, 2, or 3) CRC and found the test achieved an overall sensitivity of 96% in detecting CRC and 94% specificity. These findings are on par with other currently available modalities, such as stool-based screening.1 The limitation of this retrospective study is that the biobanked samples are from individuals with known CRC and 37% of cases had asymptomatic disease.

"We know that the earlier CRC is detected, the better a person’s chances are of surviving it," said Dr. Hee Cheol Kim, study investigator and Professor of Surgery at Samsung Medical Center in Seoul, South Korea. "The clinically meaningful sensitivity and specificity of the LUNAR-2 blood test in detecting CRC, most notably in people with early-stage disease, indicates that it could be a very useful tool in improving patient outcomes."

A further analysis showed that in patients with Stage 1 and 2 CRC, whereby blood-based detection can be especially challenging, the test offered 93% overall sensitivity. Additionally, the blood-based test identified 90% of patients with asymptomatic Stage 1 or 2 CRC, suggesting the test may have meaningful performance in an average-risk screening population. These findings need to get further validated in a registrational screening trial.

https://finance.yahoo.com/news/data-presented-acg-shows-guardant-120500062.html

Merck's Phase 3 Trials of HIV-1 Treatment Meet Primary Endpoint

 Merck & Co. said two Phase 3 trials of a combination pill for adults with HIV-1 infection met their primary efficacy endpoint.

The drugmaker on Monday said that at 48 weeks, the trials met their safety and efficacy endpoints in adults with HIV-1 infection currently on antiretroviral therapy. The endpoint is defined as a percentage of participants with HIV-1 RNA levels of more than 50 copies per milliliter, the company said.

Merck said the first trial evaluated a switch from antiretroviral therapy to doravirine/islatravir. The second trial evaluated a switch from bictegravir/emtricitabine/tenofovir to doravirine/islatravir, the company said.

Merck said it will present detailed findings from the studies at a future scientific congress.

"We will continue to study doravirine/islatravir in diverse populations of people living with HIV and look forward to sharing data from these trials," said Joan Butterton, a vice president at Merck Research Laboratories.

https://www.marketscreener.com/quote/stock/MERCK-CO-INC-13611/news/Merck-s-Phase-3-Trials-of-HIV-1-Treatment-Meet-Primary-Endpoint-36772162/

Bausch, Clearside receive U.S. approval for eye injection

 Bausch Health Companies Inc and Clearside Biomedical Inc said on Monday they received approval from the U.S. health regulator for their eye injection, giving patients access to a novel treatment for vision loss resulting from an inflammatory eye condition.

The drug, Xipere, is injected to the back of the eye and delivers a version of a steroid commonly used for the treatment of uveitis, an inflammation of tissues in the eye.

Macular edema, a build-up of fluid in a part of the retina, is the leading cause of vision loss among people with uveitis.

Xipere achieved its main goal in Clearside's late-stage study, with nearly half the patients on the treatment showing improvement in the clarity of their vision. The drug was also shown to be generally well tolerated.

With Xipere, high levels of medication can be delivered to target tissues, such as the retina and the drug can treat the swelling, leading to visual improvement, Dr. Steven Yeh, the main investigator for the study, told Reuters in an interview.

The drug delivery approach is the first of its kind for the treatment of macular edema stemming from noninfectious uveitis, which affects about 300,000 adults in the United States, Dr. Yeh said.

Other drugs used to treat the condition in the United States include Bristol Myers Squibb's Kenalog, administered near the eye and AbbVie Inc's Ozurdex eye implant. There are some topical treatments as well.

In 2019, Bausch acquired the rights to develop and sell Xipere in the United States and Canada from Clearside.

Bausch expects to make Xipere available in the United States during the first quarter of 2022.

https://finance.yahoo.com/news/bausch-clearside-receive-u-approval-104501748.html

Alkermes fast-tracked for ovarian cancer treatment

  Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company's novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, in combination with pembrolizumab, an anti-PD-1 antibody, for the treatment of platinum-resistant ovarian cancer. The FDA previously granted Fast Track designation and Orphan Drug designation to nemvaleukin for the treatment of mucosal melanoma.

"This Fast Track designation in platinum-resistant ovarian cancer highlights the potential clinical utility of nemvaleukin in combination with pembrolizumab in this difficult-to-treat disease for which there is no approved immunotherapy and there remains significant need for new treatment options," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "We are excited to initiate our planned ARTISTRY-7 phase 3 trial in platinum-resistant ovarian cancer, as we advance nemvaleukin toward potential registration and seek to help patients living with this disease."

https://finance.yahoo.com/news/alkermes-receives-fda-fast-track-110000604.html

AstraZeneca's Imfinzi-Chemotherapy Combination Improved Biliary Tract Cancer Survival

 AstraZeneca PLC said on Monday that results from its TOPAZ-1 Phase 3 trial on its human monoclonal antibody, Imfinzi, showed it significantly improved overall survival in advanced biliary tract cancer patients.

The London-listed pharmaceutical company said Imfinzi, in combination with standard-of-care chemotherapy, showed a "statistically significant and clinically meaningful" overall survival when compared with chemotherapy alone.

"We believe the significant survival benefit demonstrated marks a new era of immunotherapy treatment in this devastating disease, and it advances our commitment to improving long-term survival for patients across these cancers where treatment options are limited," the company said.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-s-Imfinzi-Chemotherapy-Combination-Improved-Biliary-Tract-Cancer-Survival-36769249/