EyeGate receives FDA approval to initiate PRK pivotal study

By Akshay Kedari  Date: 2019-06-04

EyeGate receives FDA approval to initiate PRK pivotal study

EyeGate Pharmaceuticals, Inc. has reportedly received approval from the U.S. Food and Drug Administration to start photorefractive keratectomy or PRK pivotal study.

As per trusted sources, the FDA has determined that EyeGate provided adequate data to support the initiation of the clinical study and has asked the pharma company to make some alterations in the patient informed consent document before enrollment. Sources claim that the company will immediately address these changes and looks forward to enrollments starting this month.

Sources familiar with the knowledge of the matter cite Stephen From, Chief Executive Officer of EyeGate, to have said in a statement that the company is extremely pleased with the comments received from the FDA about the design of the company’s PRK pivotal study and plans to initiate enrollment at the earliest.

The company expects topline outcomes by the end of 2019, anticipating them to be positive, so that the de novo application for commercialization can be submitted soon, From claimed, adding that post the successful approval, the company’s OGB platform will be the United States’ foremost prescription Hyaluronic Acid eyedrop formulation presenting a huge opportunity for the company.

According to a reliable news report, EyeGate Pharmaceuticals Inc. stock spiked 20% as of June 3. The company’s stock has reportedly climbed $0.05 from the earlier closing price of $0.25 on a volume of 3,160,386 stocks.

For the record, EyeGate is a clinical-stage specialty pharmacological company dedicated to developing and commercializing drugs and therapeutics through its two proprietary platform technologies focused on the treatment of eye diseases and disorders.

The company’s OBG platform formed on a crosslinked thiolated CMHA-S, a modified form of the natural polymer hyaluronic acid, which is a gel that holds unique physical and chemical features such as hydrating and healing properties when applied to the ocular surface, reported sources. 

Source Credit
https://finance.yahoo.com/news/eyegate-receives-approval-fda-initiate-105500530.html

https://www.investorsobserver.com/market-intelligence-center/stock-update/is-eyegate-pharmaceuticals-eyeg-stock-a-strong-buy-following-fda-study-approval/


 

About Author

Akshay Kedari     aeresearch.net

Akshay Kedari

A qualified computer engineering graduate, Akshay Kedari takes pride in having his way with words. Following his passion for content creation, he writes insightful pieces on aeresearch.net and a few other portals. Also endorsed with a short-term experience in web deve...

Read More

More News By Akshay Kedari

Klevu launches Discovery Suite to boost online retail conversion rates

Klevu launches Discovery Suite to boost online retail conversion rates

By Akshay Kedari

Klevu Oy, a leading provider of AI-based search technologies for online retailers, has reportedly launched a comprehensive solution called Discovery Suite that can allow brands to capture shoppers’ intent in order to improve their conversion ra...

SK Group acquires 16.3% stake in VinCommerce for USD 410 million

SK Group acquires 16.3% stake in VinCommerce for USD 410 million

By Akshay Kedari

SK Group of South Korea has purchased 16.3% of Vincommerce, Vietnams leading retail business operator, for USD 410 million in a bid to broaden its presence in the Southeast Asian region’s customer retailer sector. Sources close to the matter s...

Snapchat exploring options to bypass Apple’s upcoming privacy policies

Snapchat exploring options to bypass Apple’s upcoming privacy policies

By Akshay Kedari

Reportedly, American camera and social media company Snap Inc. is exploring different methods to circumvent Apple’s upcoming privacy regulations which will prohibit apps from collecting iPhone user information. Apple’s highly controversi...

SK Innovation might pull its battery business from the United States

SK Innovation might pull its battery business from the United States

By Akshay Kedari

SK Innovation Co., a South Korea-based petrochemical, energy, and e-mobility battery manufacturer, has recently announced its plans of withdrawing its battery operations from America if U.S. President Joe Biden fails to overrule a trade panel decisio...

Jeep planning to establish EV charging networks near off-road routes

Jeep planning to establish EV charging networks near off-road routes

By Akshay Kedari

Jeep, the American multinational automobile manufacturer, is reportedly planning to develop EV charging networks near or at off-road routes across several locations in the U.S, in a bid to look beyond conventional roads and to offer consistent chargi...