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Oyster Point dry eye drug is approved, but omission in label crimps financing plan

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A medicine that initially reached the market as a smoking cessation pill now has new life as a dry eye disease drug in a formulation administered through the nose. The FDA on Monday approved Oyster Point Pharma’s nasal spray version of the drug, varenicline, as a treatment for the signs and symptoms of dry eye disease.

The drug is the first nasal spray approved for treating dry eye and it’s also the first approved product for Oyster Point. The Princeton, New Jersey-based biotech will market the spray under the name “Tyrvaya.” Oyster Point said it expects Tyrvaya will become available in November coming in cartons containing two multidose nasal spray bottles. Each bottle will have enough doses for 15 days.

The Oyster Point drug offers a new way to treat dry eye disease, a condition whose growing prevalence the company attributes to an aging population, autoimmune conditions, contact lens wear, and time spent viewing digital screens. The drug is designed to stimulate the nicotinic acetylcholine receptor. In the Pfizer smoking cessation product Chantix, the pill’s active ingredient, varenicline, binds to these receptors and stimulates them, but not to the degree that nicotine does. Binding to the receptors also prevents nicotine from activating them. Oyster Point’s nasal spray targets the same receptors, but with the intended effect of activating them to stimulate the cells and glands governing tear film production.

Tyrvaya is meant to be sprayed into each nostril twice-daily. Oyster Point said that as a nasal spray, its drug offers a new way to treat dry eye without administering medication to an already irritated eye surface. Also, for patients who have trouble giving themselves eye drops, the nasal spray formulation could be an easier alternative.

The FDA based its approval on the results of three clinical trials enrolling more than 1,000 patients with mild, moderate, or severe dry eye disease. Patients were permitted to use artificial tears during the study. The drug was evaluated by measuring the change in score according to a scale that rates the level of eye dryness discomfort. Results showed that patients treated with the Oyster Point drug showed statistically significant improvement in tear film production at week four of the study. The results also showed improvement in basal tear secretion in the treatment groups compared to those who were given a nasal spray with no active ingredient.

The most common adverse reaction in the studies was sneezing, reported in 82% of patients. Other events reported in the clinical trials included cough, throat irritation, and nose irritation.

An eye dryness score, achieved by having patients rate their level of eye dryness discomfort, was evaluated in both clinical settings and in a Controlled Adverse Environment, a chamber that offers a controlled setting for evaluating dry eye drugs. The Oyster Point drug met the eye dryness score goal in clinical settings. But the pandemic threw a wrench into plans to evaluate the drug in the controlled environment. The company said in its annual report under pandemic conditions some patients were unable to visit sites or sites were not comfortable putting staff into the controlled environment. Those factors led to results in the controlled setting that were not statistically significant.

Oyster Point will need to do some negotiating to receive all of the financing it planned to commercialize its new drug. In August, the company secured $125 million in debt financing from OrbiMed Royalty & Credit Opportunities. The agreement provides for loans in three separate tranches: $45 million up front; $50 million upon FDA approval of the drug; and another $30 million upon meeting a recurring sales threshold.

In a securities filing, Oyster Point said that the second tranche is contingent on a label that includes eye dryness score data from clinical trials. Because the controlled environment results fell short of statistical significance, the approved label does not include those data. Unless OrbiMed waives the eye dryness score requirement, Oyster Point will be unable to secure the second tranche, and therefore won’t be eligible for the third tranche. But the company does have cash available. According to the filing, Oyster Point’s cash holdings totaled $184 million as of Sept. 30.

Delay in review of Omeros drug turns into an FDA rejection

The FDA turned down Omeros’ biologics license application for narsoplimab, an antibody the Seattle-based biotech developed as a treatment for thrombotic macroangiopathy, a potentially life-threatening complication affecting the capillaries that can develop in patients who receive hematopoietic stem cell transplants.

The Omeros drug was initially set to receive a regulatory decision by July 17. In May, the company disclosed that the FDA needed more time; the company submitted additional information in response to an FDA request, constituting a major amendment that extended the target date for decision by three months. On Oct. 1, Omeros announced that the FDA found “deficiencies” that preclude any  discussion of labeling or post-marketing requirements. Those deficiencies were not specified, but the disclosure was a red flag suggesting approvability problems with the Omeros drug.

Omeros said Monday that the FDA’s complete response letter stated it was difficult to estimate the treatment effect of narsoplimab and more information will be needed to support regulatory approval. The narsoplimab submission was based on a single-arm, open-label study that tested the drug in 28 patients. The results showed 17 of the 28 patients, or 61%, showed a complete response to the treatment. According to Omeros, a 15% complete response rate was the efficacy threshold agreed upon by the FDA.

The regulator did not identify any safety or manufacturing issues. For its part, Omeros said it remains confident in the efficacy of its drug, adding that the company worked with the FDA on the clinical development plan, including the single-arm study design and use of complete response as the main goal of the trial. A response was defined as achieving improvements in measures of thrombotic microangiopathy and either improvement in organ functions or freedom from needing a transfusion.

Omeros said it plans to request a meeting with the FDA to discuss the agency’s letter and what is needed to secure approval as a treatment for thrombotic microangiopathy. In addition to that disorder, Omeros is evaluating the drug in separate Phase 3 tests in two rare kidney diseases, IgA nephropathy and atypical hemolytic uremic syndrome. The drug is also in testing as a treatment for Covid-19.

Analytical testing issue deals setback for United Therapeutics drug

A United Therapeutics drug that the company developed for two different lung disorders has been rejected by the FDA due to a problem at a third-party analytical facility that tests the active ingredient used in the medicine. That deficiency was the only problem cited by the regulator, Silver Spring, Maryland-based United Therapeutics said Monday.

The drug, Tyvaso DPI, is a dry powder formulation of Tyvaso, an inhalation solution from United Therapeutics that is approved for improving exercise ability in patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

United Therapeutics sought approval for Tyvaso DPI in the same indications covered by Tyvaso. The dry powder formulation of the drug was developed using technology licensed from MannKind, a company that developed an inhaled version of insulin. That product, Afrezza won FDA approval in 2014, but MannKind’s partner, Sanofi, struggled to build a market for the drug and the pharma giant ended the partnership in 2016.

The medical device that MannKind developed to administer Afrezza, called Dreamboat, will get a new commercialization opportunity with Tyvaso DPI. The United Therapeutics drug will be delivered by that device. United Therapeutics said that dry powder formulation administered by this device will give patients a less time consuming way to take the drug. The drug will come in pre-filled, single-use, disposable cassettes, which eliminates the need for cleaning and filling the device. Also, the device and cassettes can fit into a patient’s pocket and do not require electricity.

“We are confident that the single deficiency identified in the complete response will be resolved quickly and that Tyvaso DPI can receive approval by the summer of 2022, if not earlier,” United Therapeutics CEO Martine Rothblatt said in a prepared statement.

Photo: Karen Bleier/AFP, via Getty Images

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