FDA Shoots Down Ocular Therapeutix’s Dextenza NDA
The Food and Drug Administration (FDA) denied approval of Ocular Therapeutix’s resubmitted New Drug Application (NDA) for its Dextenza dexamethasone insert 0.4 mg for treatment of post-surgery ocular pain, citing ongoing concerns with manufacturing processes. Ocular Therapeutix first submitted the NDA in September 2015. The company filed an amendment to the NDA earlier in July, but the FDA’s Complete Response Letter (CRL) states the agency did not review that information before issuing the CRL. Ocular Therapeutix is working with the FDA to identify those outstanding issues, company president, CEO, and chairman Amar Sawhney, PhD, said.
Ophthotech, Novartis Revise Fovista Pact
Nervous that a third Phase III trial of Fovista (pegpleranib)for treatment of wet age-related macular degeneration (AMD) may fail to meet endpoints, as happened in two previous Fovista trials, Ophthotech has joined its development partner Novartis in revising their collaborative agreement. Last year, Ophthotech reported disappointing results from two pivotal Phase III trials of Fovista in combination with Lucentis (ranibizumab, Genentech) for treatment of wet AMD. Meanwhile, Ophthotech announced that it is shifting its focus to treat orphan ophthalmic diseases.
Aerie Reports Positive Roclatan Safety Results
Aerie Pharmaceuticals reported the successful 12-month safety results of its Mercury 1 Phase III registration trial for Roclatan, its fixed-dose combination product candidate composed of Rhopressa (netarsudil) 0.02% and latanoprost. The latest safety results for Roclatan were consistent with those observed for the 90-day efficacy period. The trial found no new adverse events that developed following the initial 90-day period and no drug-related serious or systemic adverse events.
Kala IPO Exceeds Expectations
Kala Pharmaceuticals closed an initial public offering (IPO) that raised over $100 million – about 10% more than the company expected when it priced the IPO at $15 a share only five days before closing it. In all, Kala issued 6.9 million shares of common stock, including the underwriters’ exercise in full of their option to purchase an additional 900,000 shares, bringing the amount of gross proceeds raised to approximately $103.5 million. Kala is developing two Phase III candidates: KPI-121 1% for the treatment of inflammation and pain following ocular surgery; and KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.
Inotek May Be for Sale, But Who Will Buy?
With another failed trial of its glaucoma candidate trabodenoson in hand Inotek Pharmaceuticals Corp. is pondering options that could include selling the company, but finding a buyer could be difficult. Inotek has hired the global advisory firm Perella Weinberg Partners to help evaluate its options. Liabilities of $249.5 million far exceed Inotek’s estimated $108.7 million in cash and marketable securities at the end of second-quarter 2017.
4% CAGR for US Ophthalmic Drug Market
A rising incidence of eye diseases in the US will fuel steady growth in the US ophthalmic drug market through the next decade, according to a report by Transparency Market Research (TMR). The value of the market is set to pass $34.3 billion by 2025, posting a compound annual growth rate of 4% and rising from $24.4 billion last year.