At VaRi Bioscience we are convinced that medical progress should put more emphasis on offering solutions for gender-specific diseases and medical needs. In women’s health, we identified several underserved indications. These range from highly effective, self-controlled estrogen free contraception and tailored approaches to manage the symptoms of hypo-estrogenicity, to still underdiagnosed gynecological diseases, such as e.g. endometriosis and uterine fibroids.
Gynecological therapy summarizes the pharmacotherapy of diseases in women’s reproductive system.
Major indications are uterine fibroids as well as endometriosis, both of which affect a considerable fraction of women at different stages of their life.
Endometriosis is a painful disease. It is estimated that one in ten women in their reproductive years suffer from endometriosis. Major pain categories are pelvic pain, often menstrual pain (dysmenorrhea), pain associated with intercourse (dyspareunia), but also pain during bowel movements (dyschezia).
In endometriosis, cells of the uterine lining (endometrium) grow in areas outside the uterus. It is thought that during menstruation, endometrial cells may leave the uterus through the Fallopian tubes and settle on the peritoneal lining, most commonly on the ovaries, Fallopian tubes and the tissue lining the pelvis. The misplaced endometrial tissues react to the cyclic hormonal changes as they would do inside the uterus – with each cycle grow and thicken, break down and bleed. The surrounding tissue will react with inflammation, scaring and painful adhesions.
Endometriosis is a major cause of infertility. It is estimated that 30% of patients seeking help at a fertility clinic have endometriosis.
Though the socio-economic costs may be comparable to other chronic diseases, endometriosis has largely remained neglected in the past. At present, it is still diagnosed very late – between 5 and 10 years after first occurrence.
The backbone of pharmacotherapy are pain medications, and progestins (alone or combined with estrogens as OCs). The recent advent of oral GnRH inhibitors sparked more awareness for the indication. In order to increase tolerability for this class of compounds, newer products are combined with low doses of estrogen to reduce the estrogen-withdrawal symptoms.
The gold standard for definitive diagnosis is still the laparoscopic identification of endometriotic lesions. This is one of the reasons for the late confirmation of the disease.
In many postmenopausal women vulvovaginal atrophy (VVA) is a common and underreported medical condition associated with the decrease of estrogen levels. Symptoms of VVA may include vaginal dryness and discharge, recurrent urinary tract infections, decreased vaginal lubrication, pain during intercourse, to name just the common ones.
For women the burden of vaginal atrophy is greater than most physicians realize. Up to 50% of postmenopausal women experience symptoms of vaginal atrophy, but only about 25% of them seek medical treatment. There are around 36 million prevalent cases in the seven major market, 57% of those suffering from mild, 33% from moderate, and 10% from severe symptoms. An effective treatment option for VVA is low dosed vaginally administered estrogen. It may provide better direct relief of symptoms than orally applied estrogen. The local vaginal hormone options will not treat any menopausal symptoms besides the vaginal ones.
The World Health Organization defines health as “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.” This applies to women’s health indications such as, e.g., fertility control, hormone replacement therapy, and vulvovaginal atrophy, as well as endometriosis, uterine fibroids or overactive bladder. The delivery form of vaginal rings is perfectly suited for the treatment of such women-specific indications.
In 1960, the introduction of the first fertility control pill gave women the freedom to decide about the course of their reproductive lives.
Although hormonal contraceptives are generally well tolerated and some even offer non-contraceptive benefits, all products can generate side effects or even risks. The most serious risk is the development of deep vein thrombosis (DVT). While the exact mechanism underlying the risk of DVT remains obscure, the risk is linked to the systemic estrogen exposure. At VaRi Bioscience we believe that women deserve safe, highly effective and well tolerated contraceptive methods.
Fifty is the new forty – that equally applies to the female half of society. Women are fully engaging in their professional career, in public as well as family life. Their well-being, however, may be considerably limited by symptoms of hypo-estrogenicity after menopause. VaRi Biosciences is engaged in developing products that will effectively address such symptoms without the risks of systemic estrogen exposure.
Menopause is the phase in every woman’s life when menstrual cycles will cease. This occurs typically between the age of 48 and 55 years. The process starts with the perimenopausal phase, when the ovaries produce less estrogen and progestins, and ovulation becomes less reliable.
During perimenopause and menopause, women may experience various symptoms, which are individually different and vary in severity. Some common, normal signs include irregular periods, hot flashes, vaginal dryness, sleep disturbances, and mood swings. All of these may severely impact women’s quality-of-life.
Sometimes it can be helpful or even necessary to support women during this time with a hormone replacement therapy (HRT). The most common treatment option is currently the use of estrogen in women without a uterus and estrogen plus progestin in women who have an intact uterus.
Overactive bladder, also called OAB, is the name for a group of urinary tract symptoms frequently experienced during menopause. Although it is not classified as a disease, affected women may feel embarrassed, isolate themselves, or limit their work and social life.
The most common symptom is a sudden, uncontrolled need or urge to urinate. OAB is basically the feeling that you’ve “gotta’ go” to the bathroom urgently and too often. Leaking urine is called „incontinence”. Stress urinary incontinence (SUI), is another common bladder problem. It is different from OAB.
As many as 40 percent of women in the United States experience symptoms of OAB. Many women living with OAB don’t ask for help because they may feel uncomfortable talking about it. Therefore, the prevalence of OAB can only be estimated.
Overactive bladder symptoms can be more prevalent in the perimenopause and worsen with increasing VVA.
Vaginal estrogen therapy can help strengthen the muscles and tissues in the urethra and vaginal area. Common side effects of most oral treatments include dry eyes and dry mouth – but drinking water to quench thirst can aggravate symptoms of overactive bladder. Women would have to choose between the symptoms or the side effects of treatment.
Uterine fibroids are non-cancerous growths of the uterus. Though very many women have uterine fibroids – with estimates up to 40-80% – by far most are without any symptoms. The main symptom is heavy menstrual bleeding. In severe cases, this may lead to a reduction of hematocrit and major impact in the physical well-being.
While endometriosis is typically found in young women, uterine fibroids mostly require treatment in women in their 40s and 50s. Treatment options include watchful waiting, OCs to lower the blood loss and control the cycle and tranexamic acid during bleeding days. Ultimately, surgical removal may be required.
