Allergan Submits New Drug Application for Treatment of a Common Age-Related Eye Condition
On February 25, 2021, Allergan announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) for the investigational drug AGN-190584, more commonly known as pilocarpine 1.25% ophthalmic solution, for the treatment
of presbyopia. Presbyopia, the natural age-related loss of the eyes’ ability to focus on close-up objects, affects approximately 128
million people across the U.S., or about half of the adult population. This condition typically occurs in adults over the age of 40 years.
Symptoms, such as blurred vision up close, eyestrain or headaches, occur as a result of the hardening of the lens of the eye, preventing
it from changing shape to focus on close-up images. Although the onset and progression of presbyopia cannot be prevented, options
do exist to help alleviate signs and symptoms, including glasses, contact lenses and certain surgeries. Pilocarpine 1.25% is a once daily
eye drop that may serve as a new alternative treatment for patients who prefer not to wear eyewear or do not wish to undergo invasive
surgical procedures. It works by contracting the eye muscles, which constricts the pupil and enhances the depth of focus while still
allowing some pupil response to light, which is important in protecting the eye from damage from bright lights. Pilocarpine eye drops
have previously been approved to treat various conditions associated with the eye such as glaucoma and elevated fluid pressure within
the eye. Allergan’s NDA was submitted after data from two Phase 3 trials, GEMINI 1 and GEMINI 2, showed a favorable efficacy and
safety profile for pilocarpine 1.25%. When compared to placebo, pilocarpine 1.25% showed an improvement in near vision in lowlight conditions without sacrificing distance vision. There were no serious adverse events observed within the trial, with headache
being among the most common. If approved, this medication would provide a non-surgical alternative for individuals with presbyopia
seeking an improvement in their reading vision.
Nationwide Recall of Spironolactone Tablets Due to Mislabeling
On March 9, 2021, the FDA announced a voluntary recall of spironolactone tablets manufactured by Bryant Ranch Prepack. The
recall was issued as a result of a labeling error in which certain lots of spironolactone 50 mg were labeled as 25 mg tablets and vice
versa. Spironolactone belongs to a class of medications known as aldosterone antagonists, which work by helping the kidneys produce
more urine, thereby decreasing excess fluids in the body. It is approved to treat a variety of conditions including heart failure, edema
(fluid retention), and as an add-on therapy for patients with uncontrolled high blood pressure. A sudden change in the dose of
spironolactone may cause fluctuations in potassium levels which may lead to abnormal heart rhythms. Other potential side effects
from a change in the dose of spironolactone include elevation, or drop, in blood pressure as well as fluctuations in body weight caused
by edema. Patients are advised to contact their health care provider if they have experienced any complications related to taking this
drug. The manufacturer has arranged for the return of all recalled products from both distributors and impacted patients. As of March
9, the manufacturer had not received any reports of adverse reactions reported to their company or the FDA’s MedWatch Adverse
Event Reporting Program.
From the Industry
FDA Approves Fotivda® (tivozanib) for Renal Cell Carcinoma
On March 10, 2021, the FDA approved AVEO Oncology’s Fotivda® (tivozanib) for the treatment of adult patients with advanced
relapsed or refractory renal cell carcinoma (RCC). RCC is the most common type of kidney cancer and typically occurs as a single tumor
within a kidney but may also occur in both kidneys or spread to other organs such as the liver, lungs or brain. Traditional treatment
options for individuals with renal cell carcinoma include surgery, radiation therapy, chemotherapy, immunotherapy, and other targeted
therapies. Patients with this disease may relapse, with disease re-emerging sometimes years after initial treatment. Fotivda® works
by targeting and selectively inhibiting vascular endothelia growth factor (VEGF) receptors and other enzymes thought to contribute
to cell growth and survival. VEGF binds to VEGF receptors and promotes angiogenesis, a process by which new blood vessels form,
thereby carrying oxygen and nutrients to stimulate the growth of cells. In cancer patients, VEGF signaling has been shown to enable
tumors and cancerous cells to grow and survive. This approval comes after results from a Phase 3 study, TIVO-3, which showed that
tivozanib was superior to sorafenib — another chemotherapy drug — in producing progression-free survival (PFS) in individuals with
relapsed or refractory advanced RCC following two or more prior therapies. Median PFS in the tivozanib group was 5.6 months
compared to 3.9 months in the sorafenib group. The recommended tivozanib dose is 1.34 mg given once daily as an oral tablet for
21 consecutive days, followed by 7 days off, every 28 days until patients experience disease progression or intolerable side effects.
The most common side effects associated with the use of tivozanib included conditions such as hypertension, fatigue and diarrhea.
Available on the market as of March 22, 2021, Fotivda® offers a new treatment option for a growing number of patients with relapsed
or refractory RCC in the U.S.
New Generic Medications Entering the Marketplace
Indication: Treatment of elevated pressure inside the eye in patients with ocular hypertension or open-angle glaucoma.
Dosage Form/Strength: 1% ophthalmic suspension (10 and 15 mL)
Average Wholesale Price (AWP): Generic = $37 | Brand = $41