Official title of bill: To amend the Child Care and Development Block Grant Act of 1990 and the Head Start Act to promote child care and early learning, and for other purposes.
Official summary of bill: Child Care for Working Families Act
This bill provides funds and otherwise revises certain child care and early learning programs for low- to moderate-income families.
Specifically, the bill provides funds for the Child Care and Development Block Grant program and reestablishes it as a child care and development assistance program. It also allocates program funds for states to provide services and support to infants, toddlers, and children with disabilities.
Further, it revises the program to require each state to, among other things
create a tiered and transparent system for measuring the quality of child care providers, which must include evidence-based standards and payment rates that are based on a certain cost estimation model; assure that copayments are based on a sliding scale and that no family receiving assistance pays more than 7% of their household income on child care; and use quality child care amounts for certain activities, such as improving the supply of child care providers who provide care to infants, toddlers, and children with disabilities (e.g., professional development). It also provides funds and establishes grants for states to create preschool programs for low- to moderate-income children between the ages of three and five years.
Finally, the Department of Health and Human Services must make grants to Head Start agencies to (1) provide children with access to full-school-year and full-school-day services, (2) provide access to additional service hours for migrant and seasonal agencies, or (3) enhance the quality of existing services.
Company name: Aerie Pharmaceuticals, Inc.
Company business description: We are an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma and other diseases of the eye. Our strategy is to commercialize Rhopressa ®, approved by the FDA on December 18, 2017, in North American markets and advance our product candidate, Roclatan TM, to regulatory approval. We are in the process of hiring a commercial team that will include approximately 100 sales representatives to target approximately 12,000 high prescribing eye-care professionals throughout the United States. If we obtain regulatory approval, we currently expect to commercialize Rhopressa® and Roclatan TM in Europe on our own, and likely partner for commercialization in Japan. Subsequent to December 31, 2017, we issued and sold approximately 2.3 million additional shares of our common stock, for which we received net proceeds of approximately $136.2 million, after deducting fees and expenses, upon the completion of the "at-the-market" offering that commenced in December 2017 and pursuant to an underwriting agreement, dated January 23, 2018, related to a registered public offering. Our FDA-approved product, Rhopressa ®, is a once-daily eye drop designed to reduce elevated intraocular pressure ("IOP") in patients with open-angle glaucoma or ocular hypertension. The active ingredient in Rhopressa ®, netarsudil, is a Rho kinase inhibitor. We believe that Rhopressa® represents the first of a new drug class for reducing IOP in patients with glaucoma in over 20 years. Based on clinical data, we expect that Rhopressa® will have the potential to compete with non-PGA (prostaglandin analog) products as a preferred adjunctive therapy to prostaglandin analogs ("PGAs"), due to its targeting of the diseased tissue known as the trabecular meshwork ("TM"), its demonstrated ability to reduce IOP at consistent levels across tested baselines, and its preferred once-daily dosing relative to currently marketed non-PGA products. Adjunctive therapies currently represent nearly one-half of the glaucoma prescription market in the United States, according to IQVIA (formerly known as IMS Health). We believe that Rhopressa® may also become a preferred therapy where PGAs are contraindicated, for patients who do not respond to PGAs and for patients who choose to avoid the cosmetic issues associated with PGA products. Our advanced-stage product candidate, Roclatan TM, is a once-daily, fixed-dose combination of Rhopressa® and latanoprost, the most commonly prescribed drug for the treatment of patients with open-angle glaucoma. We plan to submit a New Drug Application ("NDA") for Roclatan TM to the FDA in the second quarter of 2018. We believe, based on our clinical data, that Roclatan TM has the potential to provide a greater IOP-reducing effect than any currently marketed glaucoma medication. Therefore, we believe that Roclatan TM, if approved, could compete with both PGA and non-PGA therapies and become the product of choice for patients requiring maximal IOP reduction, including those with higher IOPs and those who present with significant disease progression despite use of the currently available therapies. We own the worldwide rights to all indications for Rhopressa® and Roclatan TM. We have patent protection for Rhopressa® and Roclatan TM in the United States through at least 2030 and internationally through dates ranging from 2030 to 2037. Our intellectual property portfolio contains patents and pending patent applications related to composition of matter, pharmaceutical compositions, methods of use, and synthetic methods. Our collaboration with DSM, a global science-based company headquartered in the Netherlands, provides access to their bio-erodible polymer technology, and our acquisition of assets from Envisia Therapeutics Inc. ("Envisia"), which includes the right to use PRINT® manufacturing technology for ophthalmology, are designed to 1 advance our progress in developing potential future product candidates to treat retinal diseases. Aided by these technologies, we are developing two preclinical molecules focused on retinal disease. AR-13503, for which we expect to submit an Investigational New Drug application ("IND") in 2019, is an Aerie-owned Rho kinase and Protein kinase C inhibitor with potential in the treatment of wet age-related macular degeneration ("AMD"), diabetic retinopathy and related diseases of the retina, such as diabetic macular edema ("DME"). As the active metabolite of AR-13154(S), AR-13503 has shown lesion size decreases in an in vivo preclinical model of wet AMD at levels similar to the current market-leading wet AMD anti-VEGF product. Also preclinically, when used in combination with the market leading anti-VEGF product, AR-13503 produced greater lesion size reduction than the anti-VEGF product alone in a model of proliferative diabetic retinopathy. Additionally, through the Envisia asset acquisition, we are also developing AR-1105, a preclinical dexamethasone steroid implant with potential in the treatment of DME, and currently expect to submit an IND in late 2018. Further, we are evaluating our owned library of Rho kinase inhibitors for potential indications beyond ophthalmology.