Wednesday, Apr 24 2024 | Time 18:07 Hrs(IST)
image
Business EconomyPosted at: Oct 14 2020 12:49PM


SPARC reports Positive Top-line Results from Pivotal Phase 3 Clinical Trial of SDN-037

Mumbai, Oct 14 (UNI) Pharma Major, Sun Pharma Advanced Research Company Ltd. (SPARC) on Wednesday reported positive top-line results from its Phase 3 trial for its investigational drug, SDN-037, for the treatment of Inflammation and Pain associated with Ocular Surgery.
The trial met its prespecified primary and secondary objectives, demonstrating that SDN-037 is superior to its vehicle.
The objective of the trial was to assess the efficacy and safety of SDN-037 in clearing the inflammation and pain. To that end, the primary efficacy measure was the proportion of subjects with an anterior chamber cell (ACC) grade of zero (0) on Day 15 (zero inflammation). A statistically significant proportion of patients treated with SDN-037 achieved an ACC grade of 0 versus vehicle with p-values < 0.0001 in the Intent-To-Treat population.
A key secondary endpoint was the proportion of subjects with a visual analog scale (VAS) pain score of zero (0) at Day 15, and this was also statistically significant in patients treated with SDN-037 compared to vehicle.
SDN-037 was generally well-tolerated in this study with adverse events consistent with the known safety profile of difluprednate.
"On behalf of everyone at SPARC, I would like to extend my sincere gratitude to the patients, families and investigators involved in this study. We are extremely pleased with the top-line efficacy and safety results," said Anil Raghavan, CEO of SPARC.
UNI JS SB 1248
Please log in to get detailed story.
Tags: #SPARC reports Positive Top-line Results from Pivotal Phase 3 Clinical Trial of SDN-037
More News

Hyd: Former RBI Guv Duvvuri’s book launched at Kautilya

24 Apr 2024 | 5:51 PM

Hyderabad, April 24 (UNI) A book titled ‘Just A Mercenary? Notes from My Life and Career’, drawing insights from his personal and professional journey authored by Dr. Subbarao, the Former RBI Governor and Distinguished Visiting Professor at Kautilya, launched at Kautilya School of Public Policy here in Wednesday.

see more..

Kottayam-Kochi Rubber Market Rates

24 Apr 2024 | 5:07 PM

Kottayam, April 24 (UNI) Following were the Rubber Market rates announced by the Rubber Board here today per quintal.

see more..

Sensex advances 114 49 pts

24 Apr 2024 | 5:06 PM

Mumbai, Apr 24 (UNI) Extending gains for the fourth consecutive session on Wednesday, the BSE Sensex went up 114.49 pts to close high at 73,852.94 following gains in Commodities, Metal, Industrials and Health Care stocks.

see more..

Rupee advances 2 paise against USD

24 Apr 2024 | 5:05 PM

Mumbai, Apr 24 (UNI) The Rupee remained strong on Wednesday as it added two paise gains to close at 83.32 against the USD on selling US Dollar by bankers and exporters, dealers at the Foreign exchange said.

see more..
RBI issue Master Direction for ARCs; minimum Net Owned Fund set at Rs 300 cr

RBI issue Master Direction for ARCs; minimum Net Owned Fund set at Rs 300 cr

24 Apr 2024 | 4:58 PM

Mumbai, April 24 (UNI) Underlining its critical role in resolution of stressed financial assets of banks and financial institutions, the Reserve Bank of India (RBI) on Wednesday issued Master Directions for the Asset Reconstruction Companies (ARCs) and fixed minimum net owned fund (NOF) of Rs 300 crore to commence the business of securitisation or asset reconstruction.

see more..
image