Submission of HTX-019 (aprepitant) NDA for the Prevention of Postoperative Nausea and Vomiting to FDA

 

 

 

 

Heron Therapeutics, Inc.  announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-019 (aprepitant) injectable emulsion for the prevention of postoperative nausea and vomiting (PONV) in adults. HTX-019 is a proprietary intravenous (IV) formulation of aprepitant, a substance P/neurokinin-1 (NK₁) receptor antagonist (RA) that is approved for PONV prevention.

The NDA filing includes data demonstrating the bioequivalence of HTX-019 32 mg as a 30-second IV injection to oral aprepitant 40 mg, supporting its efficacy for the prevention of PONV. Results also showed HTX-019 was well-tolerated with a similar safety profile compared to oral aprepitant. Because HTX-019 is administered as an IV injection, it provides convenient, rapid, consistent, and reliable exposure in all patients and overcomes the need to take the oral formulation 1 to 3 hours before anesthesia. The HTX-019 injectable emulsion formulation intended for PONV prevention is identical to the approved CINVANTI^® (aprepitant) injectable emulsion formulation for prevention of chemotherapy-induced nausea and vomiting (CINV).

Despite advances in postoperative care, nausea and vomiting has remained a challenge for many patients undergoing surgery. There are approximately 65 million diagnostic and surgical procedures at risk of resulting in PONV in the U.S. each year. More than half of these patients are at moderate to high risk of developing PONV. Recent data has also shown that PONV can lead to increases in medical costs and delays in discharge and recovery following procedures. Aprepitant is the first and only NK₁ RA to be approved for prevention of PONV based on showing superiority to ondansetron, the current standard of care.

"In a recent Cochrane Meta-Analysis, aprepitant was found to be the most effective agent for PONV prevention with activity similar to two-drug combinations. In fact, the use of oral aprepitant has grown by almost 80% in the past three years without any promotional efforts. Our IV formulation is designed to directly deliver the active form of the drug, aprepitant, to patients over 30 seconds so it can take effect much more quickly than when taken orally," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "The HTX-019 NDA was filed with the same FDA division that previously approved CINVANTI without delays."

"There remains an important unmet need for effective and convenient products for PONV prevention," said Ashraf Habib, MBBCh, MSc, MHSc, FRCA, Chief, Division of Women's Anesthesia at Duke University Hospital. "If approved, this innovative IV formulation of aprepitant, with rapid achievement of therapeutic drug levels, will enable physicians to provide patients with a well-established agent that effectively prevents nausea and vomiting after surgery, using a route of administration that fits well in the perioperative workflow."

About HTX-019 for PONV

HTX-019 is an IV injectable emulsion formulation designed to directly deliver aprepitant, the active ingredient in EMEND^® (aprepitant) capsules, which is the only substance P/neurokinin-1 receptor antagonist to be approved in the U.S. for the prevention of postoperative nausea and vomiting (PONV) in adults. The FDA-approved dose of oral EMEND is 40 mg for PONV prevention, which is given within 3 hours prior to induction of anesthesia for surgery. In a Phase 1 clinical trial, 32 mg of HTX-019 as a 30-second IV injection was demonstrated to be bioequivalent to oral aprepitant 40 mg. The NDA for HTX-019 for PONV was submitted in November 2021.

 More

 https://en.wikipedia.org/wiki/Aprepitant

 

Obseva Announces U.S. FDA Acceptance of New Drug Application for Linzagolix

Obseva SA   announced   the New Drug Application (NDA) for linzagolix for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women has been accepted for review by the United States Food and Drug Administration (FDA). The submission is based on data from the two Phase 3 PRIMROSE trials. Linzagolix has a differentiated profile and if approved, would be the first and only GnRH receptor antagonist with flexible dosing options for uterine fibroids, including a low dose option to address the needs of women who cannot or do not want to take hormones.1,4 The FDA set a target action date of September 13, 2022 for this NDA under the Prescription Drug User Fee Act (PDUFA).

“Today marks an important milestone not only in the linzagolix clinical development process, but for Obseva as a company, and most importantly, the millions of women living with uterine fibroids throughout the US. Linzagolix is a significant innovation in the field of women’s health – an area that is consistently underinvested in – and we are incredibly excited about the potential of bringing this important treatment to market” said Brian O’Callaghan, CEO of Obseva. “We are encouraged by our positive Phase 3 PRIMROSE results. If approved, we believe linzagolix will address a significant unmet need in offering a more individualized treatment option for a broader range of women.”

The Phase 3 PRIMROSE trials of linzagolix (PRIMROSE 1: US; n=574 and PRIMROSE 2: Europe and US; n=535) investigated the efficacy and safety of two dosing regimens, 100mg once daily and 200mg once daily, alone or in combination with hormonal ABT (1 mg estradiol and 0.5 mg norethisterone acetate) for the treatment of heavy menstrual bleeding associated with uterine fibroids. The NDA submission comprises positive 24-week treatment results from both studies, as well as supportive results from Week 52 and the 76-week post-treatment follow-up.

“Uterine fibroids can have a devastating impact on women’s day-to-day life. With its unique dosing options, linzagolix has the potential to significantly advance medical options for women,” stated Elizabeth Garner, MD, MPH, Chief Medical Officer of Obseva. “A dosing option without hormonal ABT would be welcomed by the significant number of women who either have contraindications to or a personal preference to avoid the use of estrogen-based therapies, while also providing a dosing option for women in whom hormonal ABT is indicated.”

The linzagolix marketing authorization application (MAA) was validated by the European Medicine Agency (EMA) with an approval recommendation from the Committee for Medicinal Products for Human Use (CHMP) expected in Q4 2021. Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU.

https://en.wikipedia.org/wiki/Linzagolix

https://www.drugs.com/nda/linzagolix_211122.html

New Drug Application of Plinabulin (Response Letter from the FDA) for Prevention of Chemotherapy-Induced Neutropenia (CIN)...

 BeyondSpring Pharmaceuticals  announced the receipt of  a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) seeking approval of plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN). The FDA issued the CRL to indicate that they have completed their review of the application and have determined that it cannot be approved in its present form.

 

The FDA’s CRL indicated that the results of the single registrational trial (106 Phase 3) was not sufficiently robust to demonstrate benefit and that a second well controlled trial would be required to satisfy the substantial evidence requirement to support the CIN indication.

“BeyondSpring strongly believes that plinabulin in combination with G-CSF has significant potential to raise the standard of care in CIN, a devastating side effect of chemotherapy,” said Dr. Lan Huang, BeyondSpring’s co-founder, chief executive officer and chairwoman. “The Company plans to request a meeting with the FDA and remains committed to its goal of bringing plinabulin to cancer patients in need globally.”

BeyondSpring remains confident in the efficacy and safety data for plinabulin in combination with G-CSF for the prevention of CIN. The Company expects to work closely with the FDA to consider the possible future clinical pathway for CIN, which may include a second study.

Plinabulin is the first drug candidate submitted for FDA approval that has the potential to work in the critical first week of chemotherapy treatment before G-CSF is effective, to prevent the onset and improve clinical outcomes of CIN.

Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. It is a novel, intravenous infused, patent-protected, NDA-stage asset for CIN prevention and a Phase 3 anti-cancer candidate for non-small cell lung cancer (NSCLC) with recently released positive topline data. Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells, and the second is early-onset of action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). Plinabulin received Breakthrough Therapy designation and priority review from both U.S. and China FDA for the CIN prevention indication. As a “pipeline in a drug,” plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody-resistant patients.

More

https://en.wikipedia.org/wiki/Plinabulin

FDA Approves Cytalux (pafolacianine) Injection for Identification of Ovarian Cancer During Surgery

 

Target Laboratories, Inc.,  announced the U.S. Food and Drug Administration (FDA)  approval of Cytalux for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions. Cytalux is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal. Cytalux, administered by standard IV in as little as one hour before surgery, binds to folate receptors that are overexpressed in most epithelial ovarian cancersi and illuminates intraoperatively under near-infrared light.

"Complete removal of all malignant tissue is the goal of ovarian cancer surgery, however identifying all lesions can be challenging," said Dr. Janos L. Tanyi, MD, PhD, Associate Professor of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine and Investigator on the Phase 2 and 3 studies. "In the Phase 3 study, additional cancer was detected in 27% of patients, showing great promise in the ability of Cytalux to help surgeons identify malignant lesions that may otherwise be missed during surgery."

Ovarian cancer is the number one cause of gynecologic cancer death in the United Statesii. Cytoreductive surgery is a well-established treatment for ovarian cancer, however, a study showed that among patients reported to have undergone optimal cytoreduction, 40% were found to have measurable disease on 30-day postoperative imagingiii. Cytalux serves as an adjunctive tool for surgeons to identify additional malignant ovarian cancer lesions that may have been missed by standard visual inspection and palpation, increasing the detection of more cancer during surgery.

Adverse reactions consisting of nausea, vomiting, abdominal pain, flushing, indigestion, chest discomfort, and itching were reported during the administration of Cytalux (see additional Important Safety Information below).

"This FDA approval is a significant milestone towards achieving On Target's mission to make cancer visible during surgery so it can be removed more completely," said Chris Barys, President and Chief Executive Officer of On Target Laboratories. "We are excited about the potential impact Cytalux can have for patients in their fight against ovarian cancer. Our goal is to make Cytalux a standard of care for ovarian cancer surgery and we look forward to exploring the use of our technology for patients suffering from other cancers."

Cytalux received Priority Review and both Fast Track and Orphan designations from the FDA. Additionally, Cytalux is being investigated in cancer of the lung in a Phase 3 trial under Fast Track designation.

To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. On Target Laboratories' targeted fluorescent imaging agents are comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. The imaging agents illuminate the cancerous tissue, which may enable surgeons to detect more cancer that otherwise may have been left behind.

On Target's first novel compound, Cytalux, targets folate receptors commonly found on many cancers, such as ovarian cancer. A single dose of the agent is administered via intravenous infusion prior to surgery to help the surgeon identify additional malignant tissue during the operation using a near-infrared imaging system. More...

FDA Approves Livtencity (maribavir) for Post-Transplant Cytomegalovirus (CMV) Infection/Disease

Takeda Pharmaceutical Company Limited   (“Takeda”)   announced   the U.S. Food and Drug Administration (FDA)   approval of  Livtencity™ (maribavir) for the treatment of adults and pediatric patients (12 years of age or older and weighing at least 35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir, or foscarnet. Overall, more than twice the proportion of adult transplant patients with refractory or resistant (R/R) CMV infection/disease achieved confirmed CMV DNA level <LLOQ* (lower limit of quantification, i.e. <137 IU/mL) at Week 8 (end of treatment phase), the study’s primary endpoint, with Livtencity (56%; n=131/235), compared to those treated with conventional antiviral therapies (24%; n=28/117) (adjusted difference: 33%, 95% CI: 23–43; p<0.001).  Livtencity is Takeda’s second new molecular entity to receive FDA approval in FY2021.

Livtencity is a new molecular entity which targets CMV at pUL97, resulting in inhibition of viral DNA replication, encapsidation and nuclear egress. Though a rare disease overall, CMV is one of the most common infections experienced by transplant recipients, with an estimated incidence rate of around 16%–56% in solid organ transplant (SOT) recipients3 and 30%–70% in hematopoietic stem cell (HSCT) transplant patients.2 CMV can be acquired or reactivated following transplant leading to serious consequences—including loss of the transplanted organ and failure of the graft—or loss of life. In patients with compromised immunity, CMV causes clinically challenging complications that can be fatal.

Livtencity will be available in the coming days. For appropriate patients, physicians can submit a prescription to initiate access to treatment by contacting Takeda Patient Support at 1-855-268-1825.

“The FDA approval of Livtencity marks a major step forward in the treatment of post-transplant CMV, bringing a new therapeutic option to those living with this potential life-threatening opportunistic infection,” said Roy F. Chemaly, M.D., M.P.H., FACP, FIDSA, Department of Infectious Diseases, Infection Control & Employee Health at The University of Texas MD Anderson Cancer Center in Houston, TX. “In clinical studies, we observed Livtencity was statistically superior to conventional antiviral therapies in achieving the primary endpoint at Week 8.”

Prior to FDA approval, Livtencity (maribavir) was granted Orphan Drug Designation by the FDA for treatment of clinically significant CMV viremia and disease in at-risk patients, as well as Breakthrough Therapy Designation as a treatment for CMV infection and disease in transplant patients resistant or refractory to prior therapy. Takeda is looking forward to continuing our discussions with regulatory agencies across the globe to potentially bring maribavir to patients worldwide. The company is also investigating maribavir as a first-line treatment of CMV in hematopoietic stem cell transplant recipients in an ongoing Phase 3 clinical trial.

Livtencity was evaluated in the TAK-620-303 (SOLSTICE) trial, a global, multicenter, randomized, open-label, active-controlled superiority trial assessing the efficacy and safety of treatment with either maribavir or investigator-assigned treatment (IAT, conventional antiviral therapy) in 352 HSCT and SOT adult recipients with CMV infection refractory, with or without or resistance, to one or a combination of conventional antiviral therapies: ganciclovir, valganciclovir, foscarnet, or cidofovir. Participants were randomized 2:1 to receive maribavir (N=235) (400 mg, twice daily) or IAT (N=117) (as dosed by the investigator) for up to 8-weeks. After completion of the treatment period, subjects entered a 12-week follow-up phase. The primary efficacy endpoint was confirmed CMV DNA level <LLOQ* (lower limit of quantification, [i.e. <137 IU/mL] as assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test at the end of Week 8).

The most common adverse events occurring in all grades, >10% of patients receiving maribavir were taste disturbance, nausea, diarrhea, vomiting, and fatigue.  A higher proportion of subjects in the IAT group discontinued study medication due to an adverse event compared to the Livtencity group (32%, n=37/116 versus 13%, n=31/234, respectively). Taste disturbance events (46%, n=108/234) were generally mild, and rarely led to discontinuation of maribavir (1%).  In 37% of patients, these events resolved while patients remained on therapy (median duration 43 days; range 7 to 59 days).  For the patients with ongoing taste disturbance after drug discontinuation, resolution occurred in 89%.1 In patients with resolution of symptoms after drug discontinuation, the median duration of symptoms off treatment was 6 days (range 2 to 85 days). All-cause mortality was similar in each treatment group (Livtencity 11%, n=27/235; IAT 11%, n=13/117).

More..

https://en.wikipedia.org/wiki/Maribavir

https://go.drugbank.com/drugs/DB06234

FDA Approves Eprontia (topiramate) Oral Solution for Epilepsy and Preventive Treatment of Migraine

 In continuation of my update on topiramate...

Azurity Pharmaceuticals, Inc.announced the U.S. Food and Drug Administration (FDA) approval of Eprontia™ (topiramate) oral solution, 25 mg/mL.

“Our ability to address each patient’s needs, with a tailored approach and a proven therapy, is transformative for patients, caregivers, and the healthcare professionals (HCPs) who treat them,” said Amit Patel, Chairman and CEO of Azurity Pharmaceuticals. “Eprontia’s ready-to-use liquid formulation provides HCPs a therapy that addresses an unmet medical need.”

Globally, an estimated 65 million people have epilepsy, and 1 billion suffer from migraine. In the United States, 1 in 26 people will develop epilepsy at some point during their lifetime and approximately 39 million people suffer from migraines.1,2 For HCPs working with patients suffering from serious neurological conditions, such as seizures associated with epilepsy and migraine headaches, Eprontia™ provides a ready to use liquid medication for patients, such as those who have trouble swallowing pills. Caregivers also may benefit from the ease of giving the medication.

“I am pleased that there will now be an FDA-approved liquid formulation of topiramate for patients who may require or prefer a liquid formulation,” said Michael C. Smith, MD, Director, Rush Epilepsy Center, and Professor, Department of Neurological Sciences, Rush University Medical Center. “Clinical challenges have existed for years for clinicians looking for a high quality, predictable formulation option of topiramate to effectively meet the varied needs of patients and caregivers.”

More..

FDA Approves Scemblix (asciminib) for the Treatment of Philadelphia Chromosome-Positive Chronic Myeloid Leukemia (Ph+ CML)

 

Novartis announced   the US Food and Drug Administration (FDA) approval of Scemblix® (asciminib) for the treatment of chronic myeloid leukemia (CML) in two distinct indications. The FDA granted Scemblix accelerated approval for adult patients with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors (TKIs), based on major molecular response (MMR) rate at 24 weeks; and full approval for adult patients with Ph+ CML-CP with the T315I mutation. In accordance with the Accelerated Approval Program, continued approval for the first indication may be contingent upon verification and description of clinical benefit from confirmatory evidence1. Scemblix is the first FDA-approved CML treatment that works by binding to the ABL myristoyl pocket, and represents an important development for patients who experience resistance and/or intolerance to currently available TKI therapies1-3. Also known as a STAMP inhibitor in scientific literature, Scemblix is being studied across multiple treatment lines for CML-CP, including the ASC4FIRST Phase III study evaluating Scemblix as a first-line treatment.

“The introduction of TKIs twenty years ago revolutionized treatment for CML; however, there remain many patients who do not respond adequately to at least two available treatments and often experience challenging side effects that add a burden to their daily lives,” said Lee Greenberger, Chief Scientific Officer at The Leukemia & Lymphoma Society. “The approval of Scemblix may offer hope to patients by addressing gaps in CML care.”

For many patients, current treatment for CML may be limited by intolerance or resistance, and sequential use of available TKIs is associated with increased failure rates. In an analysis of patients with CML treated with two prior TKIs, approximately 55% reported intolerance to previous treatment. Additionally, a pooled analysis in the second-line setting showed that up to 70% of patients are unable to achieve major molecular response (MMR) within two years of follow-up. Moreover, patients who develop the T315I mutation are resistant to most available TKIs, leaving them at an increased risk of disease progression.

“CML can be difficult to treat when currently available treatments fail patients, when treatment side effects cannot be tolerated, or sometimes both,” expressed Dr. Michael J. Mauro**, Hematologist and Myeloproliferative Neoplasms Program Leader at Memorial Sloan Kettering Cancer Center (MSK). “The addition of Scemblix into the CML treatment landscape gives us a novel approach to combat this blood cancer, helping address clinical challenges in patients struggling after switching to a second treatment, as well as in patients who develop the T315I mutation and face significantly worse outcomes.”

FDA Approves Tyrvaya (varenicline solution) Nasal Spray for the Treatment of the Signs and Symptoms of Dry Eye Disease...

 Oyster Point Pharma, Inc. (Nasdaq: OYST),  announced  the U.S. Food and Drug Administration (FDA) approval of  Tyrvaya (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease. Tyrvaya Nasal Spray is the first and only nasal spray approved for the treatment of dry eye disease. Tyrvaya Nasal Spray is believed to bind to cholinergic receptors to activate the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease. Oyster Point Pharma is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies to treat ophthalmic diseases.

Tyrvaya Nasal Spray is a highly selective cholinergic agonist delivered twice daily as an aqueous nasal spray into each nostril to activate basal tear production. Nasal spray administration provides a new way to treat dry eye disease without administering medication onto an already irritated ocular surface. In addition, nasal delivery may allow some patients who have difficulty independently administering topical eye drops to administer independently their prescribed dry eye disease therapy.

Jeffrey Nau, Ph.D., MMS, president and CEO of Oyster Point Pharma commented, "The approval of Tyrvaya Nasal Spray marks a milestone for patients and eye care professionals by providing a new drug treatment option for the signs and symptoms of dry eye disease with a differentiated route of administration that is believed to leverage a nerve pathway that can be accessed within the nose." Dr. Nau further stated, "In any therapeutic area, it's always an exciting moment when you follow the science and develop a truly innovative pharmaceutical treatment option for patients that addresses an important unmet medical need. In conjunction with the FDA, it has been an honor to work alongside my colleagues at Oyster Point to bring Tyrvaya Nasal Spray to the dry eye disease community. We look forward to making Tyrvaya Nasal Spray available to eye care professionals and their patients."

Ed Holland, M.D., Director of Cornea Services at Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati said, "I see many patients in my practice whose lives are impacted by dry eye disease. Tyrvaya Nasal Spray is a new pharmaceutical approach with a differentiated mechanism of action for the dry eye disease community. Having a product that provides clinically meaningful production of basal tear film as early as four weeks is incredible for the dry eye patient."

Tyrvaya Nasal Spray was studied in the ONSET-1, ONSET-2, and MYSTIC clinical trials in over 1,000 patients with mild, moderate or severe dry eye disease. In ONSET-1 and ONSET-2, the majority of patients were female (74%), the mean (standard deviation [SD]) age was 61 (12.5) years, the mean (SD) baseline anesthetized Schirmer's score was 5.1 mm (2.9), and the mean (SD) baseline eye dryness score (EDS) was 59.3 (21.6). Use of artificial tears was allowed during the studies. Enrollment criteria included minimal signs [i.e., anesthetized Schirmer's score (range, 0-10 mm) and corneal fluorescein staining (range, 2-14)] and enrollment was not limited by baseline EDS (range, 2-100).

Basal tear production was measured by change from baseline in anesthetized Schirmer's score, based on a test that utilizes calibrated filter paper to wick tears and measure tear volume. Eye dryness was measured by change from baseline in Eye Dryness Score, a visual analogue scale where patients rated their level of eye dryness discomfort, with a greater reduction in score indicating greater symptom relief. Eye dryness score was evaluated both in the Controlled Adverse Environment (CAE®) * and in the clinic environment.

Tyrvaya-treated patients showed statistically significant improvements in tear film production as assessed using the anesthetized Schirmer's score (0-35 mm) at Week 4. Of the patients treated with Tyrvaya, 52% achieved ≥10 mm increase in Schirmer's score from baseline in the ONSET-1 study, and 47% achieved ≥10 mm increase in Schirmer's score from baseline in the ONSET-2 study, compared to 14% and 28% of vehicle-treated patients in the ONSET-1 study and the ONSET-2 study, respectively at Week 4 (p<0.01 in both studies). Of the patients treated with Tyrvaya, the mean change in Schirmer's score was 11.7 mm and 11.3 mm as compared to 3.2 mm and 6.3 mm in the vehicle treated patients in the ONSET-1 study and ONSET-2 study, respectively at Week 4.

In the Controlled Adverse Environment (CAE®), in ONSET-1 the observed mean change from baseline in Eye Dryness Score at week 3 was -16.0 mm in Tyrvaya-treated patients (n=45) compared to -4.4 mm in vehicle- treated patients (n=42). This endpoint was met (p<0.01). In ONSET-2, the observed mean change from baseline in Eye Dryness Score at week 4 was -10.3 mm in Tyrvaya-treated patients (n=187) compared to -7.4 mm in vehicle-treated patients (n=169). This endpoint was not met (p>0.05).

In the clinic environment, in ONSET-1 the mean change from baseline in Eye Dryness Score at week 4 was -18.9 mm in Tyrvaya-treated patients (n=46) compared to -5.4 mm in vehicle-treated patients (n=43). This endpoint was met (p=0.01). In ONSET-2, the mean change from baseline in Eye Dryness Score at week 4 was -19.8 mm in Tyrvaya-treated patients (n=255) compared to -15.4 mm in vehicle-treated patients (n=248). As the CAE® endpoint was not statistically significant, this secondary endpoint was not eligible for statistical testing and was not met.

The most common adverse reaction reported in 82% of patients was sneezing. Events that were reported in 5- 16% of patients were cough, throat irritation, and instillation-site (nose) irritation.

Tyrvaya Nasal Spray will be available with a prescription in November 2021 in cartons containing two multidose nasal spray bottles. Each nasal spray bottle covers treatment for 15 days, administered twice daily into each nostril. Samples that provide 15 days of treatment will also be made available to eye care providers.

FDA Approves Xipere (triamcinolone acetonide injectable suspension) for the Treatment of Macular Edema Associated with Uveitis

In continuation of my update on triamcinolone .......

Biomedical,Inc., a biopharmaceutical company   announced  the U.S. Food and Drug Administration (FDA)   approval of  XIPERE™ (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation.

"With this FDA approval, XIPERE™ is the first and only therapy available in the United States that utilizes the suprachoroidal space to treat patients suffering from macular edema associated with uveitis, which is the leading cause of vision loss in people with uveitis2. The utilization of the suprachoroidal space provides targeted delivery and compartmentalization of medication," said Joseph C. Papa, chairman and CEO, Bausch Health. "The approval of XIPERE™ exemplifies our commitment to bringing innovative new options to help patients improve their treatment journey. We expect to make XIPERE™ available during the first quarter of 2022."

"The suprachoroidal space is an untapped frontier in eye health. We are proud to be the pioneers in treating serious retinal diseases by implementing this novel, targeted approach. With this approval, we begin a new era in delivering therapies to the back of the eye," said George Lasezkay, Pharm.D., J.D., president and CEO, Clearside. "XIPERE™ is the first commercial product developed by Clearside, the first product approved for injection into the suprachoroidal space and the first therapy approved for macular edema associated with uveitis. Our unique approach now has the potential to positively impact this patient population, which previously had no other treatment options approved for this indication."

Macular edema is the buildup of fluid in the macula, which causes retinal swelling and distorted vision, and if left untreated, may lead to permanent vision loss. XIPERE™ is designed to treat macular edema associated with uveitis via suprachoroidal administration using the proprietary SCS Microinjector developed by Clearside. Suprachoroidal administration is an innovative technique for delivering ocular therapies that may facilitate more targeted delivery of therapeutic agents to the retina and choroid.

The SCS Microinjector® offers unique access to the back of the eye where sight-threatening disease often occurs. It is designed to provide targeted and compartmentalized delivery and higher proportions of absorption relative to intravitreal injection (IVT). Targeted drug delivery via the suprachoroidal space (SCS) may also limit corticosteroid exposure to the anterior segment5 with the potential to reduce the risk of certain adverse events, such as cataracts, intraocular pressure elevation and exacerbation of glaucoma, that are commonly associated with local delivery techniques.

"The safety and efficacy data of XIPERE™ was demonstrated in multiple clinical studies and its unique suprachoroidal administration approach provides exceptional access and high bioavailability to the posterior segment of the eye," said Steven Yeh, M.D., professor of ophthalmology and director of retinal disease and uveitis, Stanley M. Truhlsen Eye Institute, University of Nebraska Medical Center, and principal investigator for the XIPERE™ Phase 3 (PEACHTREE) pivotal study. "With the approval of XIPERE™, eye care professionals now have a new and innovative treatment option for their patients with macular edema associated with uveitis.".. More